Status:
TERMINATED
A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This 2 part study will investigate the safety, tolerability and efficacy of MabT hera in combination with RoActemra in patients with active rheumatoid arthritis despite a stable dose of methotrexate. ...
Eligibility Criteria
Inclusion
- adult patients, 18-65 years of age;
- rheumatoid arthritis, functional status I-III;
- SJC\>=4 (28 joint count) and TJC\>=4 (28 joint count) at screening and baseline;
- RF and/or anti-CCP positive;
- may have failed up to 1 approved anti-TNF agent (infliximab, etanercept or adalimumab);
- inadequate response to methotrexate, at a dose of 7.5-25mg weekly for at least 12 weeks, at a stable dose for past 4 weeks.
Exclusion
- rheumatic autoimmune disease other than rheumatoid arthritis, or significant systemic involvement secondary to rheumatoid arthritis;
- history of, or current, inflammatory joint disease other than rheumatoid arthritis;
- diagnosis of juvenile idiopathic arthritis and/or rheumatoid arthritis before age 16;
- significant cardiac or pulmonary disease;
- previous treatment with any biologic agent for rheumatoid arthritis (other than infliximab, etanercept or adalimumab).
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00845832
Start Date
March 1 2009
End Date
March 1 2013
Last Update
December 24 2014
Active Locations (24)
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1
Le Kremlin-Bicêtre, France, 94275
2
Montpellier, France, 34295
3
Paris, France, 75679
4
Strasbourg, France, 67098