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CLINICAL TRIALS PROFILE FOR KEVZARA
All Clinical Trials for KEVZARA
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT03414502 ↗ | Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response | Recruiting | University of Nebraska | Phase 3 | 2007-08-01 | This is a 16-week, open-label study to identify factors that help predict clinical responses to DMARD therapies for RA (Rheumatoid Arthritis) patients. All patients will receive a starting dose of DMARD medication(s) which may be adjusted by the investigator as needed. If a subject becomes intolerant to a DMARD medication the subject will be withdrawn from the study at the discretion of the investigator. Visits (prior to week 16) where withdrawal is determined to be necessary will be considered end of study. End of study data (week 16) as well as study serum will be collected. (Serum only collected on those subjects who have consented to the addendum Serum and DNA of this study). A portion of the blood collected at baseline, week 8 and week 16 with the addendum portion of the study is for future research and will be utilized attempting to look to detect the generation of superoxide radicals. The radicals have been shown to be associated with inflammation and may correlate with the progression of RA. If this is true, then treatment with RA should decrease the levels of these radicals signaling response to treatment. |
| NCT03600818 ↗ | Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica | Terminated | Regeneron Pharmaceuticals | Phase 3 | 2018-10-09 | Primary Objective: To evaluate the efficacy of KEVZARA (sarilumab) in patients with polymyalgia rheumatica (PMR) as assessed by the proportion of subjects with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen. Secondary Objectives: - To demonstrate the efficacy of sarilumab in patients with polymyalgia rheumatica compared to placebo, in combination with a CS taper with regards to: - Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time. - Cumulative CS (including prednisone) exposure. - To assess the safety (including immunogenicity) and tolerability of sarilumab in patients with PMR. - To measure sarilumab serum concentrations in patients with PMR. - To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire. |
| NCT03600818 ↗ | Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica | Terminated | Sanofi | Phase 3 | 2018-10-09 | Primary Objective: To evaluate the efficacy of KEVZARA (sarilumab) in patients with polymyalgia rheumatica (PMR) as assessed by the proportion of subjects with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen. Secondary Objectives: - To demonstrate the efficacy of sarilumab in patients with polymyalgia rheumatica compared to placebo, in combination with a CS taper with regards to: - Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time. - Cumulative CS (including prednisone) exposure. - To assess the safety (including immunogenicity) and tolerability of sarilumab in patients with PMR. - To measure sarilumab serum concentrations in patients with PMR. - To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire. |
| NCT03679845 ↗ | Study to Assess Sarilumab in Halting Progression of Morphea | Withdrawn | Regeneron Pharmaceuticals | Phase 1/Phase 2 | 2019-09-01 | An open-label single center trial studying the efficacy and safety of sarilumab on morphea patients. |
| NCT03679845 ↗ | Study to Assess Sarilumab in Halting Progression of Morphea | Withdrawn | Massachusetts General Hospital | Phase 1/Phase 2 | 2019-09-01 | An open-label single center trial studying the efficacy and safety of sarilumab on morphea patients. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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