Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Anti-interleukin-1 beta, ACZ885
Brief summary
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.
Interventions
DRUGACZ885
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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-α 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and infections occurrence throughout the study. | throughout the study |
| Presence of anti-ACZ885 antibodies in serum at baseline, Days 43, 71 and end of study (Day 113). | throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Disease Activity Score (DAS) at baseline and Days 43 and 113. | throughout the study |
| 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 |
| Serum concentrations of ACZ885 at each visit. | throughout the study |
Countries
Germany, Netherlands, Switzerland
Outcome results
None listed