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

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

Summary

GBI Research, the leading business intelligence provider, has released its latest research, "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.

Autoimmune disorders represent a collective group of disorders which primarily arise due to an overactive immune response of the body against substances and tissues normally present within the body. Most of them cause significant morbidity and disability and are very difficult to diagnose. The cause of autoimmune diseases remains unknown, although genetic factors play a major role in susceptibility. Some of the autoimmune diseases may be triggered by environmental exposure or by an infectious agent. They can attack any tissue or organ of the body and cause a wide range of symptoms and organ injuries, depending on the site of immune attack.

This report details "Endpoints - Clinical Trials in Autoimmune Disorders", highlighting the five major autoimmune disorders of multiple sclerosis, rheumatoid arthritis, Crohn's disease, ulcerative colitis and psoriasis. The classification of five major autoimmune diseases is based on the number of pipeline molecules present in the Phase III stage of development.

The term endpoint refers to an outcome or measure of a clinical trial. Endpoints can include all kinds of aspects, those related to the effectiveness of treatment and others. However, the endpoint selection must take into account the need to obtain the information of the highest therapeutic interest with the least risk and discomfort for the individual. Also, the endpoints must be aligned with the objectives of the study and represent the most effective way to assess pharmacological response.

Scope

This report details the clinical trial endpoints in autoimmune disorders. The report covers -
- Data and analysis on the marketed products and analysis of their efficacy and safety details
- Analysis of the five major autoimmune diseases: Multiple sclerosis, rheumatoid arthritis, Crohn's disease, ulcerative colitis and psoriasis.
- Analysis of the Phase III and Phase II clinical trials in terms of percentage cases. Also analysis of terminated trials is included in this chapter. Only industry-sponsored studies are included in the report.
- Analysis on most promising molecules of the five major autoimmune diseases with emphasis on their efficacy and safety details.
- The Company Profiling details the companies that are strong in the market

Reasons to buy

The report will help business development and marketing executives who are strategizing their product launches to -
- Build effective strategies to launch their pipeline products by identifying potential geographies.
- Exploit in-licensing and out-licensing opportunities by identifying products that might fill their portfolio gaps.
- Align your product portfolio to the markets with high growth potential.
- Develop market-entry and market expansion strategies by identifying the leading therapeutic segments and geographic markets poised for strong growth.
- Reinforce R&D pipelines by identifying new target mechanisms which can produce first-in-class molecules with increased efficiency and better safety profiles.
- Develop key strategic initiatives by understanding the key focus areas of leading companies.

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
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

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
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 Phase II Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010 61
Figure 20: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Ongoing Phase II Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 62
Figure 21: Endpoints - Clinical Trials in Autoimmune Disorders, Rheumatoid Arthritis, Ongoing Phase II Clinical Trials Classified Based on Multiple Endpoints, Global, 2000-2010 63
Figure 22: Endpoints - Clinical Trials in Autoimmune Disorders, Crohn's Disease, Completed Phase III Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010 72
Figure 23: Clinical Trials in Autoimmune Disorders, Crohn's Disease, Completed Phase III Clinical Trials Classified Based on Secondary Endpoints, Global, 2000–2010 73
Figure 24: Endpoints - Clinical Trials in Autoimmune Disorders, Crohn's Disease, Completed Phase III Clinical Trials Classified Based on Multiple Endpoints, Global, 2000-2010 74
Figure 25: Endpoints - Clinical Trials in Autoimmune Disorders, Crohn's Disease, Ongoing Phase III Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010 76
Figure 26: Endpoints - Clinical Trials in Autoimmune Disorders, Crohn's Disease, Ongoing Phase III Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 76
Figure 27: Endpoints - Clinical Trials in Autoimmune Disorders, Crohn's Disease, Completed Phase II Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010 80
Figure 28: Endpoints - Clinical Trials in Autoimmune Disorders, Crohn's Disease, Completed Phase II Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 81
Figure 29: Endpoints - Clinical Trials in Autoimmune Disorders, Crohn's Disease, Ongoing Phase II Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010 83
Figure 30: Endpoints - Clinical Trials in Autoimmune Disorders, Crohn's Disease, Ongoing Phase II Clinical Trials Classified Based on Secondary Endpoints, Global, 2000–2010 84
Figure 31: Endpoints - Clinical Trials in Autoimmune Disorders, Ulcerative Colitis, Completed Phase III Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010 90
Figure 32: Endpoints - Clinical Trials in Autoimmune Disorders, Ulcerative Colitis, Completed Phase III Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 91
Figure 33: Endpoints - Clinical Trials in Autoimmune Disorders, Ulcerative Colitis, Ongoing Phase III Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010 93
Figure 34: Endpoints - Clinical Trials in Autoimmune Disorders, Ulcerative Colitis, Ongoing Phase III Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 94
Figure 35: Endpoints - Clinical Trials in Autoimmune Disorders, Ulcerative Colitis, Ongoing Phase III Clinical Trials Classified Based on Multiple Endpoints, Global, 2000-2010 94
Figure 36: Endpoints - Clinical Trials in Autoimmune Disorders, Ulcerative Colitis, Completed Phase II Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010 97
Figure 37: Endpoints - Clinical Trials in Autoimmune Disorders, Ulcerative Colitis, Completed Phase II Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 98
Figure 38: Endpoints - Clinical Trials in Autoimmune Disorders, Ulcerative Colitis, Ongoing Phase II Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010 99
Figure 39: Endpoints - Clinical Trials in Autoimmune Disorders, Ulcerative Colitis, Ongoing Phase II Clinical Trials Classified Based on Multiple Endpoints, Global, 2000-2010 100
Figure 40: Endpoints - Clinical Trials in Autoimmune Disorders, Psoriasis, Completed Phase III Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010 108
Figure 41: Endpoints - Clinical Trials in Autoimmune Disorders, Psoriasis, Completed Phase III Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 109
Figure 42: Endpoints - Clinical Trials in Autoimmune Disorders, Psoriasis, Ongoing, Phase III Clinical Trials Classified Based on Primary Endpoints, Global, 2000–2010 111
Figure 43: Endpoints - Clinical Trials in Autoimmune Disorders, Psoriasis, Ongoing, Phase III Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 111
Figure 44: Endpoints - Clinical Trials in Autoimmune Disorders, Psoriasis, Completed Phase II Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010 115
Figure 45: Endpoints - Clinical Trials in Autoimmune Disorders, Psoriasis, Completed Phase II Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 116
Figure 46: Endpoints - Clinical Trials in Autoimmune Disorders, Psoriasis, Ongoing Phase II Clinical Trials Classified Based on Primary Endpoints, Global, 2000-2010 118
Figure 47: Endpoints - Clinical Trials in Autoimmune Disorders, Psoriasis, Ongoing Phase II Clinical Trials Classified Based on Secondary Endpoints, Global, 2000-2010 119

Companies mentioned
Biogen Idec Inc
Amgen Inc
Johnson & Johnson
Teva Pharmaceutical Industries Limited
Shire Plc
F. Hoffmann-La Roche Ltd
Merck KGaA

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