CLINICAL TRIALS PROFILE FOR CANAKINUMAB
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All Clinical Trials for canakinumab
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00424346 ↗ | Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis | Completed | Novartis | Phase 2 | 2006-11-01 | The 12-week core study was designed to evaluate risk-benefit of three subcutaneous dose regimens of ACZ885, added on to stable methotrexate (MTX) therapy (greater than or equal to 7.5 mg/week), compared to placebo in patients with active rheumatoid arthritis (RA). The study investigated the magnitude of effect as well as onset of effect for the different dose regimens. The primary objective of the extension studies was to assess long-term safety and tolerability of canakinumab (ACZ885) in patients with active RA. CACZ885A2201E1 evaluated this objective in patients who had participated in the core study (CACZ885A2201) and CACZ885A2201E2 did the same in patients who completed the first extension study. |
| NCT00487708 ↗ | Safety, Efficacy, Pharmacokinetics, Pharmacodynamics of ACZ885 in Patients With NALP3 Mutations and Clinical Symptoms | Completed | Novartis Pharmaceuticals | Phase 2 | 2005-01-01 | This study will investigate the clinical efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ACZ885, administered intravenously and subcutaneously to patients with NALP3 mutations whose clinical symptoms are either untreated or insufficiently treated and require medical intervention. |
| NCT00504595 ↗ | Safety and Efficacy of ACZ885 in Adult Patients With Established Rheumatoid Arthritis | Completed | Novartis | Phase 2 | 2007-05-01 | This study was intended to assess the safety, efficacy, and response to treatment using the American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) and to investigate a potential biomarker profile in adult patients with established rheumatoid arthritis |
| NCT00554606 ↗ | Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis | Completed | Novartis | Phase 2 | 2007-10-11 | This study will assess the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life. |
| NCT00581945 ↗ | Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients | Completed | Novartis | Phase 1/Phase 2 | 2007-01-01 | Was to evaluate the safety, tolerability and efficacy of multiple doses of canakinumab (ACZ885) vs. placebo when administered via intravenous infusion (IV), on pulmonary function in patients with COPD |
| NCT00605475 ↗ | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes | Completed | Novartis | Phase 2 | 2007-12-01 | The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose levels in response to an oral glucose tolerance test (OGTT). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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