An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Arthritis, Rheumatoid

Treatments: Drug: placebo; Drug: PH-797804

Study type: Interventional

Funder types: Industry

Identifiers

NCT00383188

2006-003577-27 (EudraCT Number)

RA POC (Other Identifier)

A6631007

Details and patient eligibility

About

Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.

Enrollment: 305 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with RA and has failed at least 1 DMARD therapy

Exclusion criteria

• Any other inflammatory arthritis and any significant history of acute or chronic infection with immunomodulatory etiology.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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305 participants in 5 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: placebo

2

Experimental group

Treatment:

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

3

Experimental group

Treatment:

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

4

Experimental group

Treatment:

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

5

Experimental group

Treatment:

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804

Drug: PH-797804