Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Cohort Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 (Anti-Interleukin-1Beta Monoclonal Antibody) in Patients With Active Rheumatoid Arthritis (RA) Despite Ongoing Treatment With Methotrexate (MTX) 15 mg or More Weekly for at Least 3 Months.
This study assessed 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.
Status | Completed |
Enrollment | 53 |
Est. completion date | August 2005 |
Est. primary completion date | August 2005 |
Accepts healthy volunteers | |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Male and female patients aged 18.5 - 65/75 years (depending on the dose group). - Diagnosis of rheumatoid arthritis (ACR 1987 revised classification for criteria for RA) with a disease duration of at least 6 months prior to randomization. - Active disease at screening and baseline evaluation (same evaluator) ) with more than 6 tender and 6 swollen joints of 28 examined (including any effused joint) and either a) Westergren erythrocyte sedimentation (ESR) = 28 mm/hour, or b) CRP = 6 mg/L. - Patients should have failed at least 1 DMARD in the past, but should not be deemed "refractory to all therapies" - Patients should have a current treatment regimen of = 15 mg methotrexate/week and with the current dose stable for approximately 3 months. - Patients were required to have an otherwise stable RA therapeutic regimen, consisting of either a stable dose of NSAIDs and/or a stable dose of oral corticosteroids (prednisone or equivalent < 10 mg daily) for at least 4 weeks prior to randomization. Exclusion Criteria: - Previous treatment with anti-TNF-a antibody therapy (or other biological therapy) within appropriate timeframe (considering the half life of the compound) - Patients who have received intra-articular or systemic corticosteroid injections having been required for treatment of acute RA flare (not being part of a regular therapeutic regimen) within four weeks prior to randomization OR require narcotic analgesics other than those accepted by the investigator for analgesia (e.g., codeine, tramadol, dextropropoxyphene) Other protocol-defined inclusion/exclusion criteria may apply. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Novartis Investigator Site | Berlin | |
Germany | Novartis Investigator Site | Hamburg | |
Germany | Novartis Investigator Site | Koeln | |
Germany | Novartis Investigator Site | Leipzig | |
Germany | Novartis Investigator Site | Munich | |
Germany | Novartis Investigator Site | Ratingen | |
Netherlands | Novartis Investigator Site | Leiden | |
Netherlands | Novartis Investigator Site | Nijmegen | |
Switzerland | Novartis Investigator Site | Bern | |
Switzerland | Novartis Investigator Site | Geneva |
Lead Sponsor | Collaborator |
---|---|
Novartis |
Germany, Netherlands, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events and infections occurrence throughout the study. | throughout the study | ||
Primary | Presence of anti-ACZ885 antibodies in serum at baseline, Days 43, 71 and end of study (Day 113). | throughout the study | ||
Secondary | ACR response criteria [including joint counts, patient/investigator disease activity and pain assessment, acute phase reactants (ESR and CRP) and a Health Assessment Questionnaire (HAQ)] . | throughout the study | ||
Secondary | Disease Activity Score (DAS) at baseline and Days 43 and 113. | throughout the study | ||
Secondary | Quantification of IL-1B, IL-6, and C-reactive protein (CRP), matrix metalloproteinases (MMPs) 1 and 3, and c-telopeptide of Type I collagen (Crosslaps), at Week 7 versus baseline. | throughout the study | ||
Secondary | Serum concentrations of ACZ885 at each visit. | throughout the study |
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