A Phase 2 interventional study of P38 Inhibitor (4) and P38 Inhibitor (4) in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 61 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses of P38 Inhibitor (4) or methotrexate. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 204 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: P38 Inhibitor (4)
Drug: P38 Inhibitor (4)
Drug: P38 Inhibitor (4)
Drug: Placebo
50mg po qd
150mg po qd
300mg po qd
po qd
Percentage of patients with ACR 20 response
Time frame: Week 12
Percentage of patients with ACR 50/70 response.
Time frame: Week 12
Change in ACR core set, DAS 28, FACIT-F fatigue assessment, AEs, laboratory parameters.
Time frame: Throughout study
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