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.
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.
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
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.
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