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

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

Endpoints - Clinical Trials in Autoimmune Disorders - Multiple Primary and Secondary Endpoints are Increasingly Being Applied to Ensure Success - GBI Research Reports
Endpoints - Clinical Trials in Autoimmune Disorders - Multiple Primary and Secondary Endpoints are Increasingly Being Applied to Ensure Success
Published Feb 14, 2012
135 pages — Published Feb 14, 2012
Price US$ 3,500.00  |  Buy this Report Now

About This Report

  
Abstract:

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, Crohns 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

  
Source:
Document ID
GBIHC139MR
Industry
Format:
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Sections

TitleStarting PageNumber of Pages
Table of Contents35
  List of Tables51
  List of Figures62
Endpoints - Clinical Trials in Autoimmune Disorders - Overview82
  Introduction81
  Types of Endpoints81
    Primary Endpoints81
    Secondary Endpoints81
  GBI Research Report Guidance91
Endpoints - Clinical Trials in Autoimmune Disorders - Top Five Autoimmune Disorders and their Product Profiling103
  Endpoints - Major Marketed Drugs of Top Five Autoimmune Disorders and their Regulatory Approval101
    Multiple Sclerosis101
    Rheumatoid Arthritis111
    Crohn s Disease111
    Ulcerative Colitis111
    Psoriasis121
Endpoints - Clinical Trials in Autoimmune Disorders - Marketed and Pipeline Products Assessment13113
  Multiple Sclerosis131
    Primary Endpoints Used in Multiple Sclerosis Clinical Trials141
    Secondary Endpoints Used in Multiple Sclerosis Clinical Trials151
    Major Marketed Drugs-Safety and Efficacy Analysis151
      Copaxone (glatiramer acetate)151
      Avonex/Rebif (interferon beta)161
      Tysabri (natalizumab)171
      Novantrone (mitoxantrone)181
      Betaseron/Betaferon191
    Phase III Clinical Trial Analysis201
      Primary Endpoints of Phase III Completed Trials201
      Secondary Endpoints of Phase III Completed Trials213
      Primary Endpoints of Phase III Ongoing Trials241
      Secondary Endpoints of Phase III Ongoing Trials252
    Most Promising Drug Profiles271
      Teriflunomide271
      BG-12281
    Phase II Clinical Trial Analysis291
      Primary Endpoints of Phase II Completed Trials291
      Secondary Endpoints of Phase II Completed Trials303
      Primary Endpoints of Phase II Ongoing Trials331
      Secondary Endpoints of Phase II Ongoing Trials332
    Terminated Trials351
  Rheumatoid Arthritis361
    Primary Endpoints Used in Rheumatoid Arthritis Clinical Trials361
    Secondary Endpoints Used in Rheumatoid Arthritis Clinical Trials371
    Major Marketed Drugs - Safety and Efficacy Analysis381
      Enbrel (etanercept)381
      Humira (adalimumab)381
      Remicade (infliximab)391
      Rituxan (rituximab)401
      Celebrex (celecoxib)401
    Phase III Clinical Trial Analysis411
      Primary Endpoints of Phase III Completed Trials411
      Secondary Endpoints of Phase III Completed Trials425
      Primary Endpoints of Phase III Ongoing Trials471
      Secondary Endpoints of Phase III Ongoing Trials483
    Most Promising Drug Profiles511
      T-614 (iguratimod)521
      CP-690550521
      Ocrelizumab (humanized anti-cd20 mAb)531
    Phase II Clinical Trial Analysis541
      Primary Endpoints of Phase II Completed Trials541
      Secondary Endpoints of Phase II Completed Trials556
      Primary Endpoints of Phase II Ongoing Trials611
      Secondary Endpoints of Phase II Ongoing Trials623
    Terminated Trials651
  Crohn s Disease661
    Primary Endpoints Used in Crohn s Disease Clinical Trials661
    Secondary Endpoints Used in Crohn s Disease Clinical Trials671
    Major Marketed Drugs-Safety and Efficacy Analysis671
      Humira (adalimumab)671
      Tysabri (natalizumab)681
      Remicade (infliximab)691
      Cimzia (certolizumab pegol)701
      Entocort EC (budesonide)711
    Phase III Clinical Trial Analysis721
      Primary Endpoints of Phase III Completed Trials721
      Secondary Endpoints of Phase III Completed Trials733
      Primary Endpoints of Phase III Ongoing Trials761
      Secondary Endpoints of Phase III Ongoing Trials761
    Most Promising Drug Profiles771
      Myoconda781
      Traficet-EN (CCX282)781
      MLN0002 (vedolizumab)791
    Phase II Clinical Trial Analysis801
      Primary Endpoints of Phase II Completed Trials801
      Secondary Endpoints of Phase II Completed Trials812
      Primary Endpoints of Phase II Ongoing Trials831
      Secondary Endpoints of Phase II Ongoing Trials841
    Terminated Trials Analysis841
  Ulcerative Colitis851
    Primary Endpoints Used in Ulcerative Colitis Clinical Trials861
    Secondary Endpoints Used in Ulcerative Colitis Clinical Trials861
    Major Marketed Drugs-Safety and Efficacy Analysis871
      Asacol871
      Lialda871
      Pentasa881
      Colazal891
      Remicade891
    Phase III Clinical Trial Analysis901
      Primary Endpoints of Phase III Completed Trials901
      Secondary Endpoints of Phase III Completed Trials912
      Primary Endpoints of Phase III Ongoing Trials931
      Secondary Endpoints of Phase III Ongoing Trials941
    Most Promising Drug Profiles951
      Golimumab961
      Vedolizumab961
    Phase II Clinical Trial Analysis971
      Primary Endpoints of Phase II Completed Trials971
      Secondary Endpoints of Phase II Completed Trials981
      Primary Endpoints of Phase II Ongoing Trials991
      Secondary Endpoints of Phase II Ongoing Trials1001
    Terminated Trials Analysis1001
  Psoriasis1011
    Primary Endpoints Used in Psoriasis Clinical Trials1011
    Secondary Endpoints Used in Psoriasis Clinical Trials1021
    Major Marketed Drugs-Safety and Efficacy Analysis1021
      Enbrel (etanercept)1021
      Humira (adalimumab)1031
      Amevive (alefacept)1041
      Remicade (infliximab)1052
      Dovonex (calcipotriene)1071
    Phase III Clinical Trial Analysis1081
      Primary Endpoints of Phase III Completed Trials1081
      Secondary Endpoints of Phase III Completed Trials1092
      Primary Endpoints of Phase III Ongoing Trials1111
      Secondary Endpoints of Phase III Ongoing Trials1111
    Most Promising Drugs Profiles1121
      Voclosporin (lx211, luveniq, isa-247)1131
      ABT-874 (j-695, briakinumab)1141
      Orencia (abatacept, CTLA4-Ig, BMS-188667)1151
    Phase II Clinical Trial Analysis1151
      Primary Endpoints of Phase II Completed Trials1151
      Secondary Endpoints of Phase II Completed Trials1162
      Primary Endpoints of Phase II Ongoing Trials1181
      Secondary Endpoints of Phase II Ongoing Trials1191
    Terminated Trials Analysis1206
Endpoints - Clinical Trials in Autoimmune Disorders - Company Profiling1264
  Biogen Idec Inc1261
    Company Overview1261
    Major Autoimmune Disease Drugs1261
  Amgen Inc1261
    Company Overview1261
    Major Autoimmune Disease Drugs1271
  Johnson &Johnson1271
    Company Overview1271
    Major Autoimmune Disease Drugs1271
  Teva Pharmaceutical Industries Limited1281
    Company Overview1281
    Major Autoimmune Disease Drugs1281
  Shire Plc1281
    Company Overview1281
    Major Autoimmune Disease Drugs1281
  F. Hoffmann-La Roche Ltd1291
    Company Overview1291
    Major Autoimmune Disease Drugs1291
  Merck KGaA1291
    Company Overview1291
    Major Autoimmune Disease Drugs1291
Endpoints - Clinical Trials in Autoimmune Disorders - Appendix1306
  Market Definitions1301
  Abbreviations1303
  Research Methodology1332
    Clinical Trial Design Overview1331
    Top Five Indications in Autoimmune Disorders and their Product Profiling1331
    Marketed and Pipeline Products Assessment1331
    Company Profiling1341
  Contact Us1341
  Disclaimer1341
  Sources1342

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Cite this Report

  
MLA:
GBI Research Reports. "Endpoints - Clinical Trials in Autoimmune Disorders - Multiple Primary and Secondary Endpoints are Increasingly Being Applied to Ensure Success" Feb 14, 2012. Alacra Store. May 11, 2025. <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Endpoints-Clinical-Trials-in-Autoimmune-Disorders-Multiple-Primary-and-Secondary-Endpoints-are-Increasingly-Being-Applied-to-Ensure-Success-2115-355>
  
APA:
GBI Research Reports. (2012). Endpoints - Clinical Trials in Autoimmune Disorders - Multiple Primary and Secondary Endpoints are Increasingly Being Applied to Ensure Success Feb 14, 2012. New York, NY: Alacra Store. Retrieved May 11, 2025 from <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Endpoints-Clinical-Trials-in-Autoimmune-Disorders-Multiple-Primary-and-Secondary-Endpoints-are-Increasingly-Being-Applied-to-Ensure-Success-2115-355>
  
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