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
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00620685
First received: January 10, 2008
Last updated: May 16, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis, Rheumatoid |
Drug: Placebo Drug: PH-797804 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Adverse events, laboratory data, vital signs, 12-lead ECGs and physical examination findings [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | March 2008 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: Placebo
Tablet, once daily for 4 weeks
|
| Experimental: 2 |
Drug: PH-797804
Tablet, 1 mg PH-797804, once daily for 4 weeks
|
| Experimental: 3 |
Drug: PH-797804
Tablet, 5 mg PH-797804, once daily for 4 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620685
Locations
| United States, Arizona | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85013 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Colorado Springs, Colorado, United States, 80909 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33169 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Frederick, Maryland, United States, 21702 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Bingham Farms, Michigan, United States, 48025 | |
| Pfizer Investigational Site | |
| Kalamazoo, Michigan, United States, 49007 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Ducansville, Pennsylvania, United States, 16635 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer |
| ClinicalTrials.gov Identifier: | NCT00620685 History of Changes |
| Other Study ID Numbers: | A6631005 |
| Study First Received: | January 10, 2008 |
| Last Updated: | May 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Arthritis, rheumatoid |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013