Arthritis, Rheumatoid Clinical Trial
Official title:
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
| NCT number | NCT00620685 |
| Other study ID # | A6631005 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | March 2008 |
| Est. completion date | October 2008 |
| Verified date | November 2018 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 27 |
| Est. completion date | October 2008 |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Bingham Farms | Michigan |
| United States | Pfizer Investigational Site | Colorado Springs | Colorado |
| United States | Pfizer Investigational Site | Duncansville | Pennsylvania |
| United States | Pfizer Investigational Site | Frederick | Maryland |
| United States | Pfizer Investigational Site | Kalamazoo | Michigan |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse events, laboratory data, vital signs, 12-lead ECGs and physical examination findings | 6 weeks | ||
| Secondary | 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 |
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