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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet, once daily for 4 weeks

2

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

Tablet, 1 mg PH-797804, once daily for 4 weeks

3

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

Tablet, 5 mg PH-797804, once daily for 4 weeks

Interventions

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Placebo

Tablet, once daily for 4 weeks

Intervention Type DRUG

PH-797804

Tablet, 1 mg PH-797804, once daily for 4 weeks

Intervention Type DRUG

PH-797804

Tablet, 5 mg PH-797804, once daily for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No