CLINICAL TRIALS PROFILE FOR SARILUMAB
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All Clinical Trials for sarilumab
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01061723 ↗ | Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis | Completed | Regeneron Pharmaceuticals | Phase 2 | 2010-02-01 | Primary objective: - to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20) Secondary objectives: - to demonstrate that Sarilumab was effective on: - assessment of higher level of response [ASAS 40% response criteria (ASAS40)] - partial remission - disease activity - range of motion - Magnetic Resonance Imaging (MRI) of the spine - to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS |
| NCT01061723 ↗ | Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis | Completed | Sanofi | Phase 2 | 2010-02-01 | Primary objective: - to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20) Secondary objectives: - to demonstrate that Sarilumab was effective on: - assessment of higher level of response [ASAS 40% response criteria (ASAS40)] - partial remission - disease activity - range of motion - Magnetic Resonance Imaging (MRI) of the spine - to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS |
| NCT01061736 ↗ | Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients | Completed | Regeneron Pharmaceuticals | Phase 2/Phase 3 | 2010-03-01 | Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: - reduction of signs and symptoms of rheumatoid arthritis at 24 weeks - inhibition of progression of structural damage at 52 weeks - improvement in physical function at 16 weeks Secondary Objectives: Part B: To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks To assess the safety of sarilumab added to MTX To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy. |
| NCT01061736 ↗ | Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients | Completed | Sanofi | Phase 2/Phase 3 | 2010-03-01 | Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: - reduction of signs and symptoms of rheumatoid arthritis at 24 weeks - inhibition of progression of structural damage at 52 weeks - improvement in physical function at 16 weeks Secondary Objectives: Part B: To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks To assess the safety of sarilumab added to MTX To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy. |
| NCT01118728 ↗ | Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis | Terminated | Regeneron Pharmaceuticals | Phase 2 | 2010-06-01 | Primary Objective: - To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with ankylosing spondylitis (AS) Secondary Objective: - To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS |
| NCT01118728 ↗ | Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis | Terminated | Sanofi | Phase 2 | 2010-06-01 | Primary Objective: - To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with ankylosing spondylitis (AS) Secondary Objective: - To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS |
| NCT01146652 ↗ | Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND) | Completed | Regeneron Pharmaceuticals | Phase 3 | 2010-06-14 | Primary Objective: Assess the long term safety of sarilumab in patients with rheumatoid arthritis. Secondary Objective: Assess the long term efficacy of sarilumab in patients with rheumatoid arthritis. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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