A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis

Status:	Completed
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	8/3/2016
Start Date:	April 2006
End Date:	December 2007

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

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.

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.

We found this trial at

sites

Clinical Trial Facility in Knoxville Tennessee

Knoxville, Tennessee 37920

from

Knoxville, TN