Maraviroc in Rheumatoid Arthritis

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Maraviroc; Drug: Maraviroc Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00427934

A4001056

Details and patient eligibility

About

The purpose of this study is to evaluate whether maraviroc, an investigational drug given with methotrexate (MTX) is safe and effective in the treatment of rheumatoid arthritis in adult patients.

Full description

Following a planned interim analysis in the POC component on 21 August 2008 by the internal DMC (Data Monitoring Committee) of study A4001056, the trial was discontinued due to lack of efficacy. All participating investigators/country offices and monitors were notified on 22 August 2008 to cease patient enrollment. The DMC indicated that maraviroc was well tolerated in the Rheumatoid Arthritis patients and there were no safety concerns in the study. The termination date of this trial was 07 October 2008 when the last patient last visit occurred.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be legal age of consent
• 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

• Diagnosed with any other inflammatory arthritis or a secondary non-inflammatory arthritis that would interfere with disease activity assessments.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Treatment:

Drug: Maraviroc Placebo

1

Experimental group

Description:

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.

Treatment:

Drug: Maraviroc