EUCTR2004-004022-27-ES
Active, not recruiting
Not Applicable
Phase IIa, multicenter, randomised, double-blind, placebo controlled study of the efficacy and safety of RO0506997, an a4 integrin antagonist, in combination with methotrexate, versus methotrexate alone, in patients with mild/moderate active rheumatoid arthritis (RA) who have had a partial response to a stable dose of methotrexate.
F.Hoffmann - La Roche Ltd0 sites160 target enrollmentNovember 4, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- F.Hoffmann - La Roche Ltd
- Enrollment
- 160
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients with RA diagnosed according to the revised 1987 American Rheumatism Association (ACR) criteria.
- •2\.Having RA for a minimum of 6 months.
- •3\.Receiving treatment on an outpatient basis.
- •4\.Have failed no more than 5 DMARDs.
- •5\.Have received oral methotrexate (not necessarily at constant dose) for at least 24 weeks, with a stable dose for at least 8 weeks prior to their baseline visit. The dose of methotrexate at the baseline visit must be at least 10 mg/week and no greater than 25 mg/week.
- •6\.Swollen joint count (SJC) \= 6 (66 joint count) at baseline.
- •7\.Tender joint count (TJC) \= 8 (68 joint count) at baseline.
- •8\.At least 1 of the following 3 parameters at screening:
- •\- CRP \= 1\.5 mg/dL as determined by sensitive CRP assay
- •\- ESR \= 28 mm/h
Exclusion Criteria
- •1\.Elevation of hepatic transaminases (AST or ALT) \> 2x the upper limit of normal during previous treatment with methotrexate or leflunomide, or \>1\.5x the upper limit of normal at screening.
- •2\.Baseline QTc \> 450 msec.
- •3\.Bone/joint surgery within 6 months prior to screening (including joint fusion).
- •4\.Rheumatic autoimmune disease other than RA (Sjögren’s Syndrome with RA is allowable).
- •5\.Felty’s syndrome.
- •6\.ARA functional class IV disease.
- •7\.Active or history of rheumatoid vasculitis.
- •8\.Prior history of gout.
- •9\.Prior history of systemic diseases associated with arthritis, such as inflammatory bowel disease or infectious diseases associated with arthritis, such as Lyme disease or reactive arthritis.
- •10\.Chronic fatigue syndrome or fibromyalgia.
Outcomes
Primary Outcomes
Not specified
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