A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking Methotrexate

Pfizer

Status and phase: Completed; Phase 2

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Placebo; Drug: PH-797804

Study type: Interventional

Funder types: Industry

Identifiers

NCT00620685

A6631005

Details and patient eligibility

About

The hypothesis of this study is that the p38 inhibitor (PH-797804) will be safe and well tolerated in subjects with rheumatoid arthritis who are taking methotrexate and will not effect the blood levels of methotrexate.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult with RA for at least 6 months
• Stable weekly dosage of oral methotrexate 12.5- 25 mg/week

Exclusion criteria

• Severe, progressive and/or uncontrolled other disease
• Chronic or recent serious infection; current infection
• Concomitant use of RA therapy other than methotrexate with some exceptions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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27 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: Placebo

2

Experimental group

Treatment:

Drug: PH-797804

Drug: PH-797804

3

Experimental group

Treatment:

Drug: PH-797804

Drug: PH-797804