Maraviroc in Rheumatoid Arthritis

NCT00427934 | Terminated Phase 2 Results

• 1 other identifier: A4001056
• Study Type: interventional
• Target: 128
• Locations: 9 countries
• Sites: 44

Brief Summary

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.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• American College of Rheumatology (ACR) 20% Responders at Week 12

  A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient's Assessment of Arthritis Pain (Visual Analogue Scale \[VAS\]), Patient's Global Assessment of Arthritis (VAS), Physician's Global Assessment of Arthritis (Categorical), Health Assessment Questionnaire - Disability Index (HAQ-DI), and C-Reactive Protein (CRP).

  Week 12

Secondary Outcomes (24)

• ACR 20% Responders at Weeks 1, 2, 4, and 8

  Weeks 1, 2, 4, and 8

• ACR 50% Responders at Weeks 1, 2, 4, 8, and 12

  Weeks 1, 2, 4, 8, and 12

• ACR 70% Responders at Weeks 1, 2, 4, 8, and 12

  Weeks 1, 2, 4, 8, and 12

• Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12

  Baseline, Weeks 1, 2, 4, 8, and 12

• Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12

  Baseline, Weeks 1, 2, 4, 8, and 12

Study Arms (2)

2

PLACEBO COMPARATOR

Drug: Maraviroc Placebo

1

EXPERIMENTAL

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.

Drug: Maraviroc

Interventions

Maraviroc DRUG

300 mg (2- 150 mg tablets) are administered by mouth twice a day (BID) for 12 weeks.

1

Maraviroc Placebo DRUG

Placebo tablets to match active drug. Two tablets are administered by mouth twice a day (BID) for 12 weeks.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (44)

Pfizer Investigational Site

Huntington Beach, California, 92646, United States

Location

Pfizer Investigational Site

San Francisco, California, 94115, United States

Location

Pfizer Investigational Site

Hamden, Connecticut, 06518, United States

Location

Pfizer Investigational Site

Meriden, Connecticut, 06450, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06510-2716, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06511-5473, United States

Location

Pfizer Investigational Site

Daytona Beach, Florida, 32114, United States

Location

Pfizer Investigational Site

Port Orange, Florida, 32127, United States

Location

Pfizer Investigational Site

Savannah, Georgia, 31405, United States

Location

Pfizer Investigational Site

Savannah, Georgia, 31406, United States

Location

Pfizer Investigational Site

Moline, Illinois, 61265, United States

Location

Pfizer Investigational Site

Madisonville, Kentucky, 42431, United States

Location

Pfizer Investigational Site

Kalamazoo, Michigan, 49007, United States

Location

Pfizer Investigational Site

Kalamazoo, Michigan, 49048, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68154, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89128, United States

Location

Pfizer Investigational Site

Syracuse, New York, 13210, United States

Location

Pfizer Investigational Site

Hickory, North Carolina, 28601, United States

Location

Pfizer Investigational Site

Hickory, North Carolina, 28602, United States

Location

Pfizer Investigational Site

Minot, North Dakota, 58701, United States

Location

Pfizer Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

Pfizer Investigational Site

Maroochydore, Queensland, 4558, Australia

Location

Pfizer Investigational Site

Woodville, South Australia, 5011, Australia

Location

Pfizer Investigational Site

Hobart, Tasmania, 7001, Australia

Location

Pfizer Investigational Site

Berlin, 10117, Germany

Location

Pfizer Investigational Site

Berlin, 14059, Germany

Location

Pfizer Investigational Site

Leipzig, 04103, Germany

Location

Pfizer Investigational Site

Hyderabad, Andhra Pradesh, 500 082, India

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560 034, India

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560003, India

Location

Pfizer Investigational Site

Genova, 16132, Italy

Location

Pfizer Investigational Site

Pavia, 27100, Italy

Location

Pfizer Investigational Site

Guadalajara, Jalisco, 44690, Mexico

Location

Pfizer Investigational Site

Guadalajara, Jalisco, CP 44340, Mexico

Location

Pfizer Investigational Site

Coimbra, 3000-075, Portugal

Location

Pfizer Investigational Site

Lisbon, 1000-247, Portugal

Location

Pfizer Investigational Site

Lisbon, 1600-035, Portugal

Location

Pfizer Investigational Site

Santiago de Compostela, A Coruña, 15705, Spain

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08035, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28007, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41014, Spain

Location

Pfizer Investigational Site

Dnipropetrovsk, 49005, Ukraine

Location

Pfizer Investigational Site

Kharkiv, 61000, Ukraine

Location

Pfizer Investigational Site

Simferopol, 95017, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 22251436 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 5, 2014
• Results First Posted: February 5, 2010

Record last verified: 2014-10

Locations

UA (3); IN (3); ES (4); ME (2); IT (2); DE (3); PT (3); US (21); AU (3)