Endpoints - Clinical Trials in Autoimmune Disorders - Multiple Primary and Secondary Endpoints are Increasingly Being Applied to Ensure Success by GBIResearch

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“Endpoints - Clinical Trials in Autoimmune Disorders - Multiple Primary and Secondary Endpoints are Increasingly Being Applied to Ensure Success” which provides an insight into different endpoints used in clinical trials in autoimmune disorders. The report examines different aspects of clinical trial endpoints in autoimmune disorders, such as analysis of major marketed autoimmune drugs with an emphasis on safety and efficacy details, Phase II and Phase III clinical trial analysis for both completed and ongoing clinical trials, most promising autoimmune drugs, and terminated trial analysis. The company profiles highlight the autoimmune drugs of different companies.

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									     Endpoints - Clinical Trials in Autoimmune Disorders -
   Multiple Primary and Secondary Endpoints are Increasingly
                Being Applied to Ensure Success
 Reference Code: GBIHC139MR                                                                                                                           Publication Date: February 2012


                                     Autoimmune disorders represent a group of disorders which primarily arise due to an overactive
   ACR response criteria,            immune response in the body against substances and tissues which are normally present. Most
   clinical remission and            cause significant morbidity and disability and are difficult to diagnose. The cause of autoimmune
   PASI score were the most          disease remains unknown, although genetic factors play a major role in susceptibility. Some
   widely used secondary             autoimmune diseases may be triggered by environmental exposure or by an infectious agent. They
   endpoints for clinical trials     can attack any tissue or organ of the body and cause a wide range of symptoms and organ injuries,
   in autoimmune disorders           depending on the site of immune attack.
                                     This report details the endpoints of clinical trials for autoimmune disorders, highlighting the five
                                     major autoimmune disorders: Multiple Sclerosis (MS), Rheumatoid Arthritis (RA), Crohn's Disease
                                     (CD), Ulcerative Colitis (UC) and psoriasis. The five major autoimmune diseases are classified on
                                     the basis of the number of pipeline molecules present in Phase III.
                                     The term endpoint refers to an outcome or measure of a clinical trial. Endpoints can include a wide
                                     range of aspects, such as those related to the effectiveness of treatment. The endpoint selection
                                     must take into account the need to obtain the most information of therapeutic interest with the least
                                     risk and discomfort for the individual. Endpoints must also meet the objective of the study and
                                     represent the most effective way to assess pharmacological responses.
                                     ACR Response Criteria, Clinical Remission and PASI Score Lead As Most Widely Used
                                     Secondary Endpoints in the Clinical Trials in Top Five Autoimmune Disorders

                                       Endpoints - Clinical Trials in Autoimmune Disorders, Widely Used Secondary Endpoints
                                       in Clinical Trials for Top Five Autoimmune Disorders, Global, 2000-2010

                                                                           35



                                                                           30



                                                                           25
                                               Number of Clinical Trials




                                                                                    Rheumatoid Arthritis




                                                                           20



                                                                           15
                                                                                                                  Ulcerative Colitis




                                                                                                                                                          Multiple Sclerosis
                                                                                                                                          Psoriasis




                                                                           10
                                                                                                                                                                               Crohn's
                                                                                                                                                                               Disease




                                                                            5



                                                                            0
                                                                                ACR Response               Clinical Remission          PASI Score     EDSS Score               CDAI
                                                                                   Criteria


                                       Source: Source: GBI Research, ClinicalTrials.gov
                                       Note- ACR - American College of Rheumatology, PASI - Psoriasis Area Severity Index, EDSS - Expanded Disability Status
                                       Scale, CDAI - Crohn’s Disease Activity Index




Endpoints - Clinical Trials in Autoimmune Disorders - Multiple                                                                                       GBIHC139MR /Published FEB 2012
Primary and Secondary Endpoints are Increasingly Being                                                                                                                            Page 1
Applied to Ensure Success                                                                                      © GBI Research. This report is a licensed product and is not to be copied,
                                                                                                                                               reproduced, shared or resold in any form
                                     From 2000 to 2010, the American College of Rheumatology (ACR) response criteria was the most
                                     commonly used secondary endpoint in clinical trials for RA, followed by clinical remission which is
                                     most widely used in clinical trials for ulcerative colitis. Psoriasis Area Disease Severity (PASI)
                                     Score, Expanded Disability Status Scale (EDSS) and Crohn’s Disease Activity Index (CDAI) are the
                                     secondary endpoints which are most widely used in clinical trials for psoriasis, MS and CD
                                     respectively.
                                     Majority of the Blockbuster Drugs for Rheumatoid Arthritis Use ACR Response Criteria as
                                     Endpoint
                                     Major marketed drugs for RA are Enbrel (etanercept), Humira (adalimumab), Remicade
                                     (infliximab), Rituxan (rituximab), and Celebrex (celecoxib). With a sales figure of more than one
                                     billion, all five drugs are considered to be blockbusters. The endpoints used in their clinical trials
                                     are ACR criteria. ACR response criteria consist of clinical symptoms and signs of inflammation
                                     including fatigue, joint pain, morning stiffness, joint tenderness, joint swelling, and Erythrocyte
                                     Sedimentation Rate (ESR). This is a used as a major endpoint in most of the clinical trials for RA.
                                     Safety and Efficacy Issues and Failure to Meet Primary and Secondary Endpoints Led to
                                     Discontinuation of Most Drugs
                                     Antova was developed by Biogen Idec for the treatment of MS and many other diseases. Biogen
                                     Idec stopped all clinical trials as some patients experienced signs of blood clots. The company
                                     announced that it had halted six of its Phase II clinical trials due to safety issues.
                                     Orencia (abatacept, CTLA4-Ig, BMS-188667), a drug for the treatment of UC developed by Bristol-
                                     Myers Squibb, was discontinued. The study was terminated due to a lack of efficacy in the first
                                     group of subjects in the induction period.
                                     Raptiva (efalizumab) is a drug designed by Genentech and Merck Serono to treat psoriasis. It was
                                     approved in 2003 in the US and prescribed for adults with moderate to severe chronic psoriasis. In
                                     October 2008, the US Food and Drug Administration (FDA) passed a rule that the drug must carry
                                     stricter warnings about the risk of Progressive Multifocal Leukoencephalopathy (PML), a brain
                                     disorder caused by reactivation of latent John Cunningham (JC) virus infection due to its action of
                                     suppressing the immune system. On March 13, 2009, the FDA approved safety labeling revisions
                                     for Raptiva regarding the risks associated with the drug, leading to its withdrawal from the market
                                     as of June 8, 2009. The European Medicines Agency (EMEA) recommended the withdrawal of the
                                     drug from the European Union (EU) in February 2009 as its associated risks outweighed its
                                     efficacy.




Endpoints - Clinical Trials in Autoimmune Disorders - Multiple                                               GBIHC139MR /Published FEB 2012
Primary and Secondary Endpoints are Increasingly Being                                                                                    Page 2
Applied to Ensure Success                                              © GBI Research. This report is a licensed product and is not to be copied,
                                                                                                       reproduced, shared or resold in any form
                                     1         Table of Contents
                                     1 Table of Contents ........................................................................................................................ 3
                                       1.1    List of Tables..................................................................................................................... 5
                                       1.2    List of Figures ................................................................................................................... 6
                                     2 Endpoints - Clinical Trials in Autoimmune Disorders - Overview ................................................. 8
                                       2.1    Introduction ....................................................................................................................... 8
                                       2.2    Types of Endpoints ........................................................................................................... 8
                                          2.2.1    Primary Endpoints ..................................................................................................... 8
                                          2.2.2    Secondary Endpoints ................................................................................................ 8
                                       2.3    GBI Research Report Guidance ....................................................................................... 9
                                     3 Endpoints - Clinical Trials in Autoimmune Disorders - Top Five Autoimmune Disorders and their
                                       Product Profiling ........................................................................................................................ 10
                                       3.1    Endpoints - Major Marketed Drugs of Top Five Autoimmune Disorders and their
                                              Regulatory Approval ....................................................................................................... 10
                                          3.1.1    Multiple Sclerosis..................................................................................................... 10
                                          3.1.2    Rheumatoid Arthritis ................................................................................................ 11
                                          3.1.3    Crohn’s Disease ...................................................................................................... 11
                                          3.1.4    Ulcerative Colitis ...................................................................................................... 11
                                          3.1.5    Psoriasis .................................................................................................................. 12
                                     4 Endpoints - Clinical Trials in Autoimmune Disorders - Marketed and Pipeline Products
                                       Assessment ............................................................................................................................... 13
                                       4.1    Multiple Sclerosis ............................................................................................................ 13
                                          4.1.1    Primary Endpoints Used in Multiple Sclerosis Clinical Trials ................................... 14
                                          4.1.2    Secondary Endpoints Used in Multiple Sclerosis Clinical Trials .............................. 15
                                          4.1.3    Major Marketed Drugs-Safety and Efficacy Analysis ............................................... 15
                                          4.1.4    Phase III Clinical Trial Analysis................................................................................ 20
                                          4.1.5    Most Promising Drug Profiles .................................................................................. 27
                                          4.1.6    Phase II Clinical Trial Analysis................................................................................. 29
                                          4.1.7    Terminated Trials..................................................................................................... 35
                                       4.2    Rheumatoid Arthritis ....................................................................................................... 36
                                          4.2.1    Primary Endpoints Used in Rheumatoid Arthritis Clinical Trials .............................. 36
                                          4.2.2    Secondary Endpoints Used in Rheumatoid Arthritis Clinical Trials .......................... 37
                                          4.2.3    Major Marketed Drugs - Safety and Efficacy Analysis ............................................. 38
                                          4.2.4    Phase III Clinical Trial Analysis................................................................................ 41
                                          4.2.5    Most Promising Drug Profiles .................................................................................. 51
                                          4.2.6    Phase II Clinical Trial Analysis................................................................................. 54
                                          4.2.7    Terminated Trials..................................................................................................... 65
                                       4.3    Crohn’s Disease.............................................................................................................. 66
                                          4.3.1    Primary Endpoints Used in Crohn’s Disease Clinical Trials..................................... 66
                                          4.3.2    Secondary Endpoints Used in Crohn’s Disease Clinical Trials ................................ 67
                                          4.3.3    Major Marketed Drugs-Safety and Efficacy Analysis ............................................... 67
                                          4.3.4    Phase III Clinical Trial Analysis................................................................................ 72
                                          4.3.5    Most Promising Drug Profiles .................................................................................. 77
                                          4.3.6    Phase II Clinical Trial Analysis................................................................................. 80
                                          4.3.7    Terminated Trials Analysis ...................................................................................... 84
                                       4.4    Ulcerative Colitis ............................................................................................................. 85
                                          4.4.1    Primary Endpoints Used in Ulcerative Colitis Clinical Trials .................................... 86
                                          4.4.2    Secondary Endpoints Used in Ulcerative Colitis Clinical Trials ............................... 86
                                          4.4.3    Major Marketed Drugs-Safety and Efficacy Analysis ............................................... 87
                                          4.4.4    Phase III Clinical Trial Analysis................................................................................ 90
                                          4.4.5    Most Promising Drug Profiles .................................................................................. 95
                                          4.4.6    Phase II Clinical Trial Analysis................................................................................. 97
                                          4.4.7    Terminated Trials Analysis .................................................................................... 100
                                       4.5    Psoriasis ....................................................................................................................... 101


Endpoints - Clinical Trials in Autoimmune Disorders - Multiple                                                             GBIHC139MR /Published FEB 2012
Primary and Secondary Endpoints are Increasingly Being                                                                                                  Page 3
Applied to Ensure Success                                                            © GBI Research. This report is a licensed product and is not to be copied,
                                                                                                                     reproduced, shared or resold in any form
                                          4.5.1    Primary Endpoints Used in Psoriasis Clinical Trials .............................................. 101
                                          4.5.2    Secondary Endpoints Used in Psoriasis Clinical Trials.......................................... 102
                                          4.5.3    Major Marketed Drugs-Safety and Efficacy Analysis ............................................. 102
                                          4.5.4    Phase III Clinical Trial Analysis.............................................................................. 108
                                          4.5.5    Most Promising Drugs’ Profiles.............................................................................. 112
                                          4.5.6    Phase II Clinical Trial Analysis............................................................................... 115
                                          4.5.7    Terminated Trials Analysis .................................................................................... 120
                                     5 Endpoints - Clinical Trials in Autoimmune Disorders - Company Profiling............................... 126
                                       5.1    Biogen Idec Inc ............................................................................................................. 126
                                          5.1.1    Company Overview ............................................................................................... 126
                                          5.1.2    Major Autoimmune Disease Drugs ........................................................................ 126
                                       5.2    Amgen Inc ..................................................................................................................... 126
                                          5.2.1    Company Overview ............................................................................................... 126
                                          5.2.2    Major Autoimmune Disease Drugs ........................................................................ 127
                                       5.3    Johnson & Johnson ...................................................................................................... 127
                                          5.3.1    Company Overview ............................................................................................... 127
                                          5.3.2    Major Autoimmune Disease Drugs ........................................................................ 127
                                       5.4    Teva Pharmaceutical Industries Limited ....................................................................... 128
                                          5.4.1    Company Overview ............................................................................................... 128
                                          5.4.2    Major Autoimmune Disease Drugs ........................................................................ 128
                                       5.5    Shire Plc........................................................................................................................ 128
                                          5.5.1    Company Overview ............................................................................................... 128
                                          5.5.2    Major Autoimmune Disease Drugs ........................................................................ 128
                                       5.6    F. Hoffmann-La Roche Ltd ............................................................................................ 129
                                          5.6.1    Company Overview ............................................................................................... 129
                                          5.6.2    Major Autoimmune Disease Drugs ........................................................................ 129
                                       5.7    Merck KGaA.................................................................................................................. 129
                                          5.7.1    Company Overview ............................................................................................... 129
                                          5.7.2    Major Autoimmune Disease Drugs ........................................................................ 129
                                     6 Endpoints - Clinical Trials in Autoimmune Disorders - Appendix ............................................. 130
                                       6.1    Market Definitions ......................................................................................................... 130
                                       6.2    Abbreviations ................................................................................................................ 130
                                       6.3    Research Methodology ................................................................................................. 133
                                          6.3.1    Clinical Trial Design Overview ............................................................................... 133
                                          6.3.2    Top Five Indications in Autoimmune Disorders and their Product Profiling ........... 133
                                          6.3.3    Marketed and Pipeline Products Assessment ....................................................... 133
                                          6.3.4    Company Profiling ................................................................................................. 134
                                       6.4    Contact Us .................................................................................................................... 134
                                       6.5    Disclaimer ..................................................................................................................... 134
                                       6.6    Sources ......................................................................................................................... 134




Endpoints - Clinical Trials in Autoimmune Disorders - Multiple                                                            GBIHC139MR /Published FEB 2012
Primary and Secondary Endpoints are Increasingly Being                                                                                                 Page 4
Applied to Ensure Success                                                           © GBI Research. This report is a licensed product and is not to be copied,
                                                                                                                    reproduced, shared or resold in any form
                                     1.1       List of Tables
                                     Table 1:   Endpoints - Clinical Trials in Autoimmune Disorders, Multiple Sclerosis, Endpoints for
                                                Major Marketed Drugs, Global, 1990-2010 .................................................................... 10
                                     Table 2: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Endpoints for
                                                Major Marketed Drugs, Global, 1990 - 2010 .................................................................. 11
                                     Table 3: Endpoints - Clinical Trials in Autoimmune Disorders, Ulcerative Colitis, Endpoints for
                                                Major Marketed Drugs, Global, 1990 - 2010 .................................................................. 11
                                     Table 4: Endpoints - Clinical Trials in Autoimmune Disorders, Psoriasis, Endpoints for Major
                                                Marketed Drugs, Global,1990- 2010 .............................................................................. 12
                                     Table 5: Endpoints - Clinical Trials in Autoimmune Disorders, Multiple Sclerosis, Completed
                                                Phase III Trial Molecules, Global, 2000-2010 ................................................................ 22
                                     Table 6: Endpoints - Clinical Trials in Autoimmune Disorders, Multiple Sclerosis, Ongoing Phase
                                                III Trial Molecules, Global, 2000-2010............................................................................ 25
                                     Table 7: Endpoints - Clinical Trials in Autoimmune Disorders, Most Promising Drugs Under
                                                Clinical Development, Multiple Sclerosis, 2011.............................................................. 27
                                     Table 8: Endpoints - Clinical Trials in Autoimmune Disorders, Multiple Sclerosis, Completed
                                                Phase II Trial Molecules, Global, 2000–2010 ................................................................. 31
                                     Table 9: Endpoints - Clinical Trials in Autoimmune Disorders, Multiple Sclerosis, Ongoing Phase
                                                II Trial Molecules, Global, 2000-2010............................................................................. 34
                                     Table 10: Endpoints - Clinical Trials in Autoimmune Disorders, List of Discontinued Drugs for
                                                Multiple Sclerosis ........................................................................................................... 35
                                     Table 11: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Completed
                                                Phase III Trial Molecules, Global, 2000-2010 ................................................................ 43
                                     Table 12: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Ongoing
                                                Phase III Trial Molecules, Global, 2000-2010 ................................................................ 49
                                     Table 13: Endpoints - Clinical Trials in Autoimmune Disorders, Most Promising Drugs Under
                                                Clinical Development, Rheumatoid Arthritis, 2011 ......................................................... 51
                                     Table 14: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Completed
                                                Phase II Trial Molecules, Global, 2000-2010 ................................................................. 56
                                     Table 15: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Ongoing
                                                Phase II Trial Molecules, Global, 2000-2010 ................................................................. 63
                                     Table 16: Endpoints - Clinical Trials in Autoimmune Disorders, List of Discontinued Drugs for
                                                Rheumatoid Arthritis....................................................................................................... 65
                                     Table 17: Endpoints - Clinical Trials in Autoimmune Disorders, Crohn’s Disease, Completed Phase
                                                III Trial Molecules, Global, 2000-2010............................................................................ 74
                                     Table 18: Endpoints - Clinical Trials in Autoimmune Disorders, Crohn’s Disease, Ongoing Phase
                                                III Trial Molecules, Global, 2000-2010............................................................................ 77
                                     Table 19: Endpoints - Clinical Trials in Autoimmune Disorders, Most Promising Drugs Under
                                                Clinical Development, Crohn’s Disease, 2009 ............................................................... 77
                                     Table 20: Endpoints - Clinical Trials in Autoimmune Disorders, Crohn’s Disease, Completed Phase
                                                II Trial Molecules, Global, 2000-2010............................................................................. 82
                                     Table 21: Endpoints - Clinical Trials in Autoimmune Disorders, Crohn’s Disease, Ongoing Phase II
                                                Trial Molecules, Global, 2000-2010................................................................................ 84
                                     Table 22: Endpoints - Clinical Trials in Autoimmune Disorders, Ulcerative Colitis, Completed
                                                Phase III Trial Molecules, Global, 2000-2010 ................................................................ 92
                                     Table 23: Endpoints - Clinical Trials in Autoimmune Disorders, Ulcerative Colitis, Ongoing Phase
                                                III Trial Molecules, Global, 2000-2010............................................................................ 95
                                     Table 24: Endpoints - Clinical Trials in Autoimmune Disorders, Most Promising Drugs Under
                                                Clinical Development, Ulcerative Colitis, 2009 ............................................................... 95
                                     Table 25: Endpoints - Clinical Trials in Autoimmune Disorders, Ulcerative Colitis, Completed
                                                Phase II Trial Molecules, Global, 2000–2010 ................................................................. 98
                                     Table 26: Endpoints - Clinical Trials in Autoimmune Disorders, Ulcerative Colitis, Ongoing Phase II
                                                Trial Molecules, Global, 2000-2010.............................................................................. 100
                                     Table 27: Endpoints - Clinical Trials in Autoimmune Disorders, Psoriasis, Completed Phase III
                                                Trial Molecules, Global, 2000-2010.............................................................................. 109
                                     Table 28: Endpoints - Clinical Trials in Autoimmune Disorders, Psoriasis, Ongoing Phase III Trial
                                                Molecules, Global, 2000-2010 ..................................................................................... 112
                                     Table 29: Endpoints - Clinical Trials in Autoimmune Disorders, Most Promising Drugs Under
                                                Clinical Development, Psoriasis, 2009 ......................................................................... 112
                                     Table 30: Endpoints - Clinical Trials in Autoimmune Disorders, Psoriasis, Completed Phase II Trial
                                                Molecules, Global, 2000-2010 ..................................................................................... 116


Endpoints - Clinical Trials in Autoimmune Disorders - Multiple                                                            GBIHC139MR /Published FEB 2012
Primary and Secondary Endpoints are Increasingly Being                                                                                                 Page 5
Applied to Ensure Success                                                           © GBI Research. This report is a licensed product and is not to be copied,
                                                                                                                    reproduced, shared or resold in any form
                                     Table 31: Endpoints - Clinical Trials in Autoimmune Disorders, Psoriasis, Ongoing Phase II Trial
                                                Molecules, Global, 2000-2010 ..................................................................................... 119
                                     Table 32: Endpoints - Clinical Trials in Autoimmune Disorders, List of Discontinued Drugs for
                                                Psoriasis ...................................................................................................................... 120
                                     Table 33: Endpoints - Clinical Trials in Autoimmune Disorders, Biogen Idec Inc, Major Autoimmune
                                                Drugs, 2010 ................................................................................................................. 126
                                     Table 34: Endpoints - Clinical Trials in Autoimmune Disorders, Amgen Inc, Major Autoimmune
                                                Drugs, 2010 ................................................................................................................. 127
                                     Table 35: Endpoints - Clinical Trials in Autoimmune Disorders, Johnson & Johnson, Major
                                                Autoimmune Drugs, 2010 ............................................................................................ 127
                                     Table 36: Endpoints - Clinical Trials in Autoimmune Disorders, Teva Pharmaceutical Industries
                                                Limited, Major Autoimmune Drugs, 2010 ..................................................................... 128
                                     Table 37: Endpoints - Clinical Trials in Autoimmune Disorders, Shire Plc, Major Autoimmune
                                                Drugs, 2010 ................................................................................................................. 128
                                     Table 38: Endpoints - Clinical Trials in Autoimmune Disorders, F. Hoffmann-La Roche Ltd, Major
                                                Autoimmune Drugs, 2010 ............................................................................................ 129
                                     Table 39: Endpoints - Clinical Trials in Autoimmune Disorders, Merck KGaA, Major Autoimmune
                                                Drugs, 2010 ................................................................................................................. 129


                                     1.2       List of Figures
                                     Figure 1: Endpoints - Clinical Trials in Autoimmune Disorders, Number of Pipeline Products in
                                                Phase III of Development, 2011 ..................................................................................... 10
                                     Figure 2: Endpoints - Clinical Trials in Autoimmune Disorders, Multiple Sclerosis, Completed
                                                Phase III Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010..... 20
                                     Figure 3: Endpoints - Clinical Trials in Autoimmune Disorders, Multiple Sclerosis, Completed
                                                Phase III Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 21
                                     Figure 4: Endpoints - Clinical Trials in Autoimmune Disorders, Multiple Sclerosis, Ongoing Phase
                                                III Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010................ 24
                                     Figure 5: Endpoints - Clinical Trials in Autoimmune Disorders, Multiple Sclerosis, Ongoing Phase
                                                III Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 ........... 25
                                     Figure 6: Endpoints - Clinical Trials in Autoimmune Disorders, Multiple Sclerosis, Completed
                                                Phase II Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010...... 29
                                     Figure 7: Endpoints - Clinical Trials in Autoimmune Disorders, Multiple Sclerosis, Completed
                                                Phase II Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 . 30
                                     Figure 8: Endpoints - Clinical Trials in Autoimmune Disorders, Multiple Sclerosis, Ongoing Phase
                                                II Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010................. 33
                                     Figure 9: Endpoints - Clinical Trials in Autoimmune Disorders, Multiple Sclerosis, Ongoing Phase
                                                II Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 ............ 33
                                     Figure 10: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Completed
                                                Phase III Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010..... 41
                                     Figure 11: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Completed
                                                Phase III Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 42
                                     Figure 12: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Completed
                                                Phase III Clinical Trials Classified Based on Multiple Endpoints, Global, 2000-2010..... 43
                                     Figure 13: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Ongoing
                                                Phase III Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010..... 47
                                     Figure 14: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Ongoing
                                                Phase III Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 48
                                     Figure 15: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Ongoing
                                                Phase III Clinical Trials Classified Based on Multiple Endpoints, Global, 2000-2010..... 49
                                     Figure 16: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Ongoing
                                                Phase III Clinical Trials Classified Based on Multiple Endpoints, Global, 2000-2010..... 54
                                     Figure 17: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Completed
                                                Phase II Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 . 55
                                     Figure 18: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Completed
                                                Phase II Clinical Trials Classified Based on Multiple Endpoints, Global, 2000-2010...... 56
                                     Figure 19: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Ongoing
                 
								
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