A Phase 3 interventional study of tocilizumab [RoActemra/Actemra] and tocilizumab [RoActemra/Actemra] in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 74 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-06-11.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with moderate to severe active rheumatoid arthritis (RA) who currently have an inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's enrollment of 623 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: tocilizumab [RoActemra/Actemra] · Drug: Methotrexate
Drug: tocilizumab [RoActemra/Actemra] · Drug: Methotrexate
Drug: Placebo · Drug: Methotrexate
4mg/kg iv / month
8mg/kg iv / month
iv / month
10-25mg/week
Percentage of patients with ACR 20 response
Time frame: Week 24
Percentage of patients ACR 50/70 responses; change from baseline in ACR core set components.
Time frame: Week 24
AEs, laboratory parameters, vital signs
Time frame: Throughout study
This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche