Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Rheumatoid Arthritis With Ongoing Treatment With Methotrexate
Lead Sponsor:
Novartis
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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
- 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/exclusion criteria may apply.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00619905
Start Date
December 1 2003
End Date
August 1 2005
Last Update
February 21 2008
Active Locations (10)
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1
Novartis Investigator Site
Berlin, Germany
2
Novartis Investigator Site
Cologne, Germany
3
Novartis Investigator Site
Hamburg, Germany
4
Novartis Investigator Site
Leipzig, Germany