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

A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Safety And Pharmacokinetic Profile Of 1 And 5 Mg Ph-797804 Administered Once Daily In Subjects With Rheumatoid Arthritis Who Are Taking Oral Methotrexate

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00620685

Enrollment

Registered

2008-02-21

Start date

2008-03-31

Completion date

2008-10-31

Last updated

2018-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

Arthritis, rheumatoid

Brief summary

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.

Interventions

DRUGPlacebo

Tablet, once daily for 4 weeks

DRUGPH-797804

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Adverse events, laboratory data, vital signs, 12-lead ECGs and physical examination findings	6 weeks

Secondary

Measure	Time frame
Estimate the effects of multiple doses of PH-797804 on the pharmacokinetic profile of methotrexate in subjects with RA taking a stable dose of MTX	6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026