A Phase 3 interventional study of Methotrexate and Placebo in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 168 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.
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 in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. 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 499 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: Methotrexate · Drug: tocilizumab [RoActemra/Actemra]
Drug: Methotrexate · Drug: tocilizumab [RoActemra/Actemra]
Drug: Methotrexate · Drug: Placebo
10-25mg weekly
iv every 4 weeks
8mg/kg iv every 4 weeks
4mg/kg iv every 4 weeks
Percentage of patients with ACR 20 response
Time frame: Week 24
AEs, laboratory parameters, vital signs, ECGs.
Time frame: Throughout study
Percentage of patients with ACR 50 and ACR 70 responses
Time frame: Week 24
Mean changes in parameters of ACR core set
Time frame: Week 24
Showing the first 100 of 168 sites across 14 countries.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche