Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
128 participants
INTERVENTIONAL
2007-02-28
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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2
Maraviroc Placebo
Placebo tablets to match active drug. Two tablets are administered by mouth twice a day (BID) for 12 weeks.
1
This study was divided into two components: safety/pharmacokinetic (PK) and proof-of-concept (POC). In the safety/PK component either 150 mg or 300 mg tablets of maraviroc was administered twice a day (BID) to 16 rheumatoid arthritis subjects for 4 weeks.
Maraviroc
300 mg (2- 150 mg tablets) are administered by mouth twice a day (BID) for 12 weeks.
Interventions
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Maraviroc
300 mg (2- 150 mg tablets) are administered by mouth twice a day (BID) for 12 weeks.
Maraviroc Placebo
Placebo tablets to match active drug. Two tablets are administered by mouth twice a day (BID) for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Must have active rheumatoid arthritis based upon the American College of Rheumatology (ACR) 1987 (Revised Criteria); minimum disease criteria required for entry into the efficacy component of the study
* Must meet ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II, or III
* Must be receiving methotrexate for at least 12 weeks duration and on a stable dose for 4 weeks.
Exclusion Criteria
* Subject receiving prior treatment with certain medications for rheumatoid arthritis
* Tuberculosis and/or a positive tuberculin reaction
* Significant trauma or major surgery within 2 months
* History of alcohol and/or drug abuse outside of a defined period of abstinence
* History of or a finding at screening of postural hypotension
* Any condition that would affect the oral absorption of the drug
* History of cancer and in remission less than 3 years or Grade III-IV congestive heart failure
* Having an infection of human immunodeficiency virus (HIV), Hepatitis B or C or evidence of any active infection
* Abnormalities of clinical or laboratory assessments completed at the screening visit such as elevated liver enzymes, decreased hemoglobin or an abnormal ECG
* Having a positive chemokine receptor 5 (CCR5) delta 32 mutation
* Requiring the use of certain medications
* Lactating or pregnant women or subjects have reproductive potential unwilling to use an adequate method of birth control
* Chronic or recent serious or life-threatening infection; severe , progressive and/or uncontrollable renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease within 12 weeks of the first dose.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Huntington Beach, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Hamden, Connecticut, United States
Pfizer Investigational Site
Meriden, Connecticut, United States
Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
Daytona Beach, Florida, United States
Pfizer Investigational Site
Port Orange, Florida, United States
Pfizer Investigational Site
Savannah, Georgia, United States
Pfizer Investigational Site
Savannah, Georgia, United States
Pfizer Investigational Site
Moline, Illinois, United States
Pfizer Investigational Site
Madisonville, Kentucky, United States
Pfizer Investigational Site
Kalamazoo, Michigan, United States
Pfizer Investigational Site
Kalamazoo, Michigan, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
Las Vegas, Nevada, United States
Pfizer Investigational Site
Syracuse, New York, United States
Pfizer Investigational Site
Hickory, North Carolina, United States
Pfizer Investigational Site
Hickory, North Carolina, United States
Pfizer Investigational Site
Minot, North Dakota, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, United States
Pfizer Investigational Site
Maroochydore, Queensland, Australia
Pfizer Investigational Site
Woodville, South Australia, Australia
Pfizer Investigational Site
Hobart, Tasmania, Australia
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Leipzig, , Germany
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India
Pfizer Investigational Site
Bangalore, Karnataka, India
Pfizer Investigational Site
Bangalore, Karnataka, India
Pfizer Investigational Site
Genova, , Italy
Pfizer Investigational Site
Pavia, , Italy
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico
Pfizer Investigational Site
Coimbra, , Portugal
Pfizer Investigational Site
Lisbon, , Portugal
Pfizer Investigational Site
Lisbon, , Portugal
Pfizer Investigational Site
Santiago de Compostela, A Coruña, Spain
Pfizer Investigational Site
Barcelona, Barcelona, Spain
Pfizer Investigational Site
Madrid, Madrid, Spain
Pfizer Investigational Site
Seville, Sevilla, Spain
Pfizer Investigational Site
Dnipropetrovsk, , Ukraine
Pfizer Investigational Site
Kharkiv, , Ukraine
Pfizer Investigational Site
Simferopol, , Ukraine
Countries
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References
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Fleishaker DL, Garcia Meijide JA, Petrov A, Kohen MD, Wang X, Menon S, Stock TC, Mebus CA, Goodrich JM, Mayer HB, Zeiher BG. Maraviroc, a chemokine receptor-5 antagonist, fails to demonstrate efficacy in the treatment of patients with rheumatoid arthritis in a randomized, double-blind placebo-controlled trial. Arthritis Res Ther. 2012 Jan 17;14(1):R11. doi: 10.1186/ar3685.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A4001056
Identifier Type: -
Identifier Source: org_study_id
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