Sections
Title | Starting Page | Number of Pages |
---|
Table of Contents | 3 | 5 |
List of Tables | 5 | 1 |
List of Figures | 6 | 2 |
Endpoints - Clinical Trials in Autoimmune Disorders - Overview | 8 | 2 |
Introduction | 8 | 1 |
Types of Endpoints | 8 | 1 |
Primary Endpoints | 8 | 1 |
Secondary Endpoints | 8 | 1 |
GBI Research Report Guidance | 9 | 1 |
Endpoints - Clinical Trials in Autoimmune Disorders - Top Five Autoimmune Disorders and their Product Profiling | 10 | 3 |
Endpoints - Major Marketed Drugs of Top Five Autoimmune Disorders and their Regulatory Approval | 10 | 1 |
Multiple Sclerosis | 10 | 1 |
Rheumatoid Arthritis | 11 | 1 |
Crohn s Disease | 11 | 1 |
Ulcerative Colitis | 11 | 1 |
Psoriasis | 12 | 1 |
Endpoints - Clinical Trials in Autoimmune Disorders - Marketed and Pipeline Products Assessment | 13 | 113 |
Multiple Sclerosis | 13 | 1 |
Primary Endpoints Used in Multiple Sclerosis Clinical Trials | 14 | 1 |
Secondary Endpoints Used in Multiple Sclerosis Clinical Trials | 15 | 1 |
Major Marketed Drugs-Safety and Efficacy Analysis | 15 | 1 |
Copaxone (glatiramer acetate) | 15 | 1 |
Avonex/Rebif (interferon beta) | 16 | 1 |
Tysabri (natalizumab) | 17 | 1 |
Novantrone (mitoxantrone) | 18 | 1 |
Betaseron/Betaferon | 19 | 1 |
Phase III Clinical Trial Analysis | 20 | 1 |
Primary Endpoints of Phase III Completed Trials | 20 | 1 |
Secondary Endpoints of Phase III Completed Trials | 21 | 3 |
Primary Endpoints of Phase III Ongoing Trials | 24 | 1 |
Secondary Endpoints of Phase III Ongoing Trials | 25 | 2 |
Most Promising Drug Profiles | 27 | 1 |
Teriflunomide | 27 | 1 |
BG-12 | 28 | 1 |
Phase II Clinical Trial Analysis | 29 | 1 |
Primary Endpoints of Phase II Completed Trials | 29 | 1 |
Secondary Endpoints of Phase II Completed Trials | 30 | 3 |
Primary Endpoints of Phase II Ongoing Trials | 33 | 1 |
Secondary Endpoints of Phase II Ongoing Trials | 33 | 2 |
Terminated Trials | 35 | 1 |
Rheumatoid Arthritis | 36 | 1 |
Primary Endpoints Used in Rheumatoid Arthritis Clinical Trials | 36 | 1 |
Secondary Endpoints Used in Rheumatoid Arthritis Clinical Trials | 37 | 1 |
Major Marketed Drugs - Safety and Efficacy Analysis | 38 | 1 |
Enbrel (etanercept) | 38 | 1 |
Humira (adalimumab) | 38 | 1 |
Remicade (infliximab) | 39 | 1 |
Rituxan (rituximab) | 40 | 1 |
Celebrex (celecoxib) | 40 | 1 |
Phase III Clinical Trial Analysis | 41 | 1 |
Primary Endpoints of Phase III Completed Trials | 41 | 1 |
Secondary Endpoints of Phase III Completed Trials | 42 | 5 |
Primary Endpoints of Phase III Ongoing Trials | 47 | 1 |
Secondary Endpoints of Phase III Ongoing Trials | 48 | 3 |
Most Promising Drug Profiles | 51 | 1 |
T-614 (iguratimod) | 52 | 1 |
CP-690550 | 52 | 1 |
Ocrelizumab (humanized anti-cd20 mAb) | 53 | 1 |
Phase II Clinical Trial Analysis | 54 | 1 |
Primary Endpoints of Phase II Completed Trials | 54 | 1 |
Secondary Endpoints of Phase II Completed Trials | 55 | 6 |
Primary Endpoints of Phase II Ongoing Trials | 61 | 1 |
Secondary Endpoints of Phase II Ongoing Trials | 62 | 3 |
Terminated Trials | 65 | 1 |
Crohn s Disease | 66 | 1 |
Primary Endpoints Used in Crohn s Disease Clinical Trials | 66 | 1 |
Secondary Endpoints Used in Crohn s Disease Clinical Trials | 67 | 1 |
Major Marketed Drugs-Safety and Efficacy Analysis | 67 | 1 |
Humira (adalimumab) | 67 | 1 |
Tysabri (natalizumab) | 68 | 1 |
Remicade (infliximab) | 69 | 1 |
Cimzia (certolizumab pegol) | 70 | 1 |
Entocort EC (budesonide) | 71 | 1 |
Phase III Clinical Trial Analysis | 72 | 1 |
Primary Endpoints of Phase III Completed Trials | 72 | 1 |
Secondary Endpoints of Phase III Completed Trials | 73 | 3 |
Primary Endpoints of Phase III Ongoing Trials | 76 | 1 |
Secondary Endpoints of Phase III Ongoing Trials | 76 | 1 |
Most Promising Drug Profiles | 77 | 1 |
Myoconda | 78 | 1 |
Traficet-EN (CCX282) | 78 | 1 |
MLN0002 (vedolizumab) | 79 | 1 |
Phase II Clinical Trial Analysis | 80 | 1 |
Primary Endpoints of Phase II Completed Trials | 80 | 1 |
Secondary Endpoints of Phase II Completed Trials | 81 | 2 |
Primary Endpoints of Phase II Ongoing Trials | 83 | 1 |
Secondary Endpoints of Phase II Ongoing Trials | 84 | 1 |
Terminated Trials Analysis | 84 | 1 |
Ulcerative Colitis | 85 | 1 |
Primary Endpoints Used in Ulcerative Colitis Clinical Trials | 86 | 1 |
Secondary Endpoints Used in Ulcerative Colitis Clinical Trials | 86 | 1 |
Major Marketed Drugs-Safety and Efficacy Analysis | 87 | 1 |
Asacol | 87 | 1 |
Lialda | 87 | 1 |
Pentasa | 88 | 1 |
Colazal | 89 | 1 |
Remicade | 89 | 1 |
Phase III Clinical Trial Analysis | 90 | 1 |
Primary Endpoints of Phase III Completed Trials | 90 | 1 |
Secondary Endpoints of Phase III Completed Trials | 91 | 2 |
Primary Endpoints of Phase III Ongoing Trials | 93 | 1 |
Secondary Endpoints of Phase III Ongoing Trials | 94 | 1 |
Most Promising Drug Profiles | 95 | 1 |
Golimumab | 96 | 1 |
Vedolizumab | 96 | 1 |
Phase II Clinical Trial Analysis | 97 | 1 |
Primary Endpoints of Phase II Completed Trials | 97 | 1 |
Secondary Endpoints of Phase II Completed Trials | 98 | 1 |
Primary Endpoints of Phase II Ongoing Trials | 99 | 1 |
Secondary Endpoints of Phase II Ongoing Trials | 100 | 1 |
Terminated Trials Analysis | 100 | 1 |
Psoriasis | 101 | 1 |
Primary Endpoints Used in Psoriasis Clinical Trials | 101 | 1 |
Secondary Endpoints Used in Psoriasis Clinical Trials | 102 | 1 |
Major Marketed Drugs-Safety and Efficacy Analysis | 102 | 1 |
Enbrel (etanercept) | 102 | 1 |
Humira (adalimumab) | 103 | 1 |
Amevive (alefacept) | 104 | 1 |
Remicade (infliximab) | 105 | 2 |
Dovonex (calcipotriene) | 107 | 1 |
Phase III Clinical Trial Analysis | 108 | 1 |
Primary Endpoints of Phase III Completed Trials | 108 | 1 |
Secondary Endpoints of Phase III Completed Trials | 109 | 2 |
Primary Endpoints of Phase III Ongoing Trials | 111 | 1 |
Secondary Endpoints of Phase III Ongoing Trials | 111 | 1 |
Most Promising Drugs Profiles | 112 | 1 |
Voclosporin (lx211, luveniq, isa-247) | 113 | 1 |
ABT-874 (j-695, briakinumab) | 114 | 1 |
Orencia (abatacept, CTLA4-Ig, BMS-188667) | 115 | 1 |
Phase II Clinical Trial Analysis | 115 | 1 |
Primary Endpoints of Phase II Completed Trials | 115 | 1 |
Secondary Endpoints of Phase II Completed Trials | 116 | 2 |
Primary Endpoints of Phase II Ongoing Trials | 118 | 1 |
Secondary Endpoints of Phase II Ongoing Trials | 119 | 1 |
Terminated Trials Analysis | 120 | 6 |
Endpoints - Clinical Trials in Autoimmune Disorders - Company Profiling | 126 | 4 |
Biogen Idec Inc | 126 | 1 |
Company Overview | 126 | 1 |
Major Autoimmune Disease Drugs | 126 | 1 |
Amgen Inc | 126 | 1 |
Company Overview | 126 | 1 |
Major Autoimmune Disease Drugs | 127 | 1 |
Johnson &Johnson | 127 | 1 |
Company Overview | 127 | 1 |
Major Autoimmune Disease Drugs | 127 | 1 |
Teva Pharmaceutical Industries Limited | 128 | 1 |
Company Overview | 128 | 1 |
Major Autoimmune Disease Drugs | 128 | 1 |
Shire Plc | 128 | 1 |
Company Overview | 128 | 1 |
Major Autoimmune Disease Drugs | 128 | 1 |
F. Hoffmann-La Roche Ltd | 129 | 1 |
Company Overview | 129 | 1 |
Major Autoimmune Disease Drugs | 129 | 1 |
Merck KGaA | 129 | 1 |
Company Overview | 129 | 1 |
Major Autoimmune Disease Drugs | 129 | 1 |
Endpoints - Clinical Trials in Autoimmune Disorders - Appendix | 130 | 6 |
Market Definitions | 130 | 1 |
Abbreviations | 130 | 3 |
Research Methodology | 133 | 2 |
Clinical Trial Design Overview | 133 | 1 |
Top Five Indications in Autoimmune Disorders and their Product Profiling | 133 | 1 |
Marketed and Pipeline Products Assessment | 133 | 1 |
Company Profiling | 134 | 1 |
Contact Us | 134 | 1 |
Disclaimer | 134 | 1 |
Sources | 134 | 2 |