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Maraviroc in Rheumatoid Arthritis

Last updated on November 13, 2019

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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Descriptive Information
Brief Title  ICMJE Maraviroc in Rheumatoid Arthritis
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionFollowing 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *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.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 13, 2010)
128
Original Enrollment  ICMJE
 (submitted: January 25, 2007)
130
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion DateOctober 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   India,   Italy,   Mexico,   Portugal,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00427934
Other Study ID Numbers  ICMJE A4001056
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2014

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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