A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy

Roche

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: P38 Inhibitor (4) 50mg; Drug: P38 Inhibitor (4) 75mg; Drug: Placebo; Drug: P38 Inhibitor (4) 150mg; Drug: P38 Inhibitor (4) 300mg; Drug: P38 Inhibitor (4) 25mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00316771

PA18439

Details and patient eligibility

About

This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor (4) in patients with RA currently having an inadequate clinical response to methotrexate. Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75 bid po) or placebo, and will remain on the stable dose of methotrexate. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Enrollment: 374 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >=18 years of age;
• active rheumatoid arthritis;
• current inadequate clinical response to methotrexate.

Exclusion criteria

• receiving any other disease-modifying anti-rheumatic drug, with the exception of hydroxychloroquine or chloroquine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

374 participants in 6 patient groups, including a placebo group

P38 Inhibitor (4) 150mg

Experimental group

Treatment:

Drug: P38 Inhibitor (4) 150mg

P38 Inhibitor (4) 25mg

Experimental group

Treatment:

Drug: P38 Inhibitor (4) 25mg

P38 Inhibitor (4) 300mg

Experimental group

Treatment:

Drug: P38 Inhibitor (4) 300mg

P38 Inhibitor (4) 50mg

Experimental group

Treatment:

Drug: P38 Inhibitor (4) 50mg

P38 Inhibitor (4) 75mg

Experimental group

Treatment:

Drug: P38 Inhibitor (4) 75mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo