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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00620685
First received: January 10, 2008
Last updated: May 16, 2011
Last verified: May 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014