A Randomized, Double-blind Study to Compare the Effect of RO4402257 Monotherapy and Methotrexate Monotherapy on Disease Response in Patients With Active Rheumatoid Arthritis.

Hoffmann-La Roche0 sites204 target enrollmentApril 2006

ConditionsRheumatoid Arthritis

InterventionsP38 Inhibitor (4)Placebo

DrugsP38 Inhibitor (4)Placebo

Overview

Phase: Phase 2
Intervention: P38 Inhibitor (4)
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 204
Primary Endpoint: Percentage of patients with ACR 20 response
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

December 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•adult patients \>18 years of age, with active RA;
•receiving treatment for RA on an outpatient basis;
•females of child-bearing potential, or nonsterilized males with partners of child-bearing potential, must use reliable contraception during, and for 4 weeks after, the study.

Exclusion Criteria

•major surgery within 8 weeks prior to screening;
•rheumatic autoimmune disease or inflammatory joint disease other than RA;
•treatment with methotrexate within 8 weeks of baseline;
•concurrent use of DMARDs, including anti-TNF or other biologic therapy for RA.

Arms & Interventions

1

Intervention: P38 Inhibitor (4)

2

Intervention: P38 Inhibitor (4)

3

Intervention: P38 Inhibitor (4)

4

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage of patients with ACR 20 response

Time Frame: Week 12

Secondary Outcomes

Percentage of patients with ACR 50/70 response.(Week 12)
Change in ACR core set, DAS 28, FACIT-F fatigue assessment, AEs, laboratory parameters.(Throughout study)