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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00504595 |
This study will assess the safety, efficacy, and response to treatment using the American College of Rheumatology criteria of 20% improvement in symptoms (ACR20) and to investigate a potential biomarker profile in adult patients with established rheumatoid arthritis
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: ACZ885 Drug: Placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12-Week, Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Response to Treatment (ACR20) and to Determine a Biomarker Profile in Adult Patients With Established Rheumatoid Arthritis Responding to ACZ885 (Anti-Interleukin-1beta Monoclonal Antibody) as Compared to Healthy Subjects Exposed to ACZ885 |
Estimated Enrollment: | 80 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | June 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental
ACZ885
|
Drug: ACZ885 |
2: Placebo Comparator
Placebo
|
Drug: Placebo |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
RA patients:
Exclusion Criteria:
RA patients:
Previous treatment with anti-TNF-α or anti IL-1 therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate or tacrolimus. The following washout period will be required for such patients to be eligible to participate in the trial.
Other protocol-defined inclusion/exclusion criteria may apply
Russian Federation | |
Novartis Investigative site | |
Moscow, Russian Federation | |
Spain | |
Novartis investigative site | |
Barcelona, Spain | |
Switzerland | |
Novartis Investigative site | |
Bern, Switzerland | |
Turkey | |
Novartis investigative site | |
Istanbul, Turkey |
Principal Investigator: | Novartis | Investigator site |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CACZ885A2207 |
Study First Received: | July 19, 2007 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00504595 |
Health Authority: | Spain: Spanish Agency of Medicines |
Rheumatoid Arthritis |
Antibodies, Monoclonal Antibodies Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Healthy Rheumatic Diseases Immunoglobulins |
Immune System Diseases |