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

Roche

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: P38 Inhibitor (4)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00303563

PA18604

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: P38 Inhibitor (4)

Drug: P38 Inhibitor (4)

Drug: P38 Inhibitor (4)

2

Experimental group

Treatment:

Drug: P38 Inhibitor (4)

Drug: P38 Inhibitor (4)

Drug: P38 Inhibitor (4)

3

Experimental group

Treatment:

Drug: P38 Inhibitor (4)

Drug: P38 Inhibitor (4)

Drug: P38 Inhibitor (4)

4

Placebo Comparator group

Treatment:

Drug: Placebo