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Maraviroc in Rheumatoid Arthritis

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Huntington Beach, California, 92646 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00427934
Pfizer
Terminated
Maraviroc in Rheumatoid Arthritis

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Maraviroc in Rheumatoid Arthritis
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Maraviroc in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: Maraviroc
    300 mg (2- 150 mg tablets) are administered by mouth twice a day (BID) for 12 weeks.
  • Drug: Maraviroc Placebo
    Placebo tablets to match active drug. Two tablets are administered by mouth twice a day (BID) for 12 weeks.
  • Placebo Comparator: 2
    Intervention: Drug: Maraviroc Placebo
  • Experimental: 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.
    Intervention: Drug: Maraviroc
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
128
October 2008
October 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Germany,   India,   Italy,   Mexico,   Portugal,   Spain,   Ukraine,   United States
 
 
NCT00427934
A4001056
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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