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 - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00620685

Purpose

A 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 II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study
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

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:	February 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo Tablet, once daily for 4 weeks
2: Experimental	Drug: PH-797804 Tablet, 1 mg PH-797804, once daily for 4 weeks
3: Experimental	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
Kalamazoo, Michigan, United States, 49007
Pfizer Investigational Site
Bingham Farms, Michigan, United States, 48025
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

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6631005
Study First Received:	January 10, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00620685
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Arthritis, rheumatoid

Study placed in the following topic categories:

Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009