A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATE - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-001035-58-IT
• Date of registration: 05/10/2007
• Prospective Registration: Yes
• Primary sponsor: PFIZER
• Public title: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATE - ND
• Scientific title: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATE - ND
• Date of first enrolment: 21/11/2007
• Target sample size: 114
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001035-58
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Italy, Portugal, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1. Must be legal age of consent; 2. Must have active RA based upon the American College of Rheumatology (ACR) 1987 (Revised Criteria) and a current level of disease activity defined as: >/=6 tender/painful joints on motion (28 joint count) ? Waived for entry into the Safety/PK Component >/=6 swollen joints (28 joint count) ? Waived for entry into the Safety/PK Component CRP>/=0.8 mg/dL (8 mg/L) or an erythrocyte sedimentation rate (ESR) of at least 28 mm/hour ? Waived for entry into the Safety/PK Component. 3. Must meet ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II, or III; 4. Must be receiving MTX treatment that satisfies all of the following: >/=10 mg/week and /=12 weeks duration of prior therapy; MTX dose has been stable >/=4 weeks prior to entry and will remain unchanged throughout the 12-week Treatment Period. 5. Must provide written informed consent and be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Subjects with a diagnosis of: any other inflammatory arthritis (eg, spondyloarthropathies); or a secondary, non-inflammatory arthritis (eg, osteoarthritis, fibromyalgia) that may interfere with disease activity assessments. 2. Subjects who have received the following prior treatments: Within prior 4 weeks: Auranofin (oral gold), injectable gold (aurothioglucose or aurothiomalate), sulfasalazine, d-penicillamine, antimalarials* (chloroquine and hydroxychloroquine); azathioprine, cyclosporine, intra-articular, peri-articular, intramuscular or intravenous corticosteroids, anakrina (Kineret), etanercept (Enbrel), herbal supplements including fish oil, or leflunomide (see additional washout information for leflunomide in Section 5.6); (*POC Component only: subjects on stable doses of antimalarials (chloroquine and hydroxychlorquine) for at least 60 days may continue these medications). Within prior 8 weeks: Infliximab (Remicade), adalimumab (Humira). Within prior 8 weeks: Any experimental therapy for RA (within or outside a clinical trial); with the exception of experimental NSAID/COX-2 inhibitors for which a washout interval of not less than 5 half-lives shall apply. Within prior 3 months: abatacept (Orencia). Within prior 12 months: rituximab (Rixutan). 3. Subjects with a history of: chronic or recent serious or life-threatening infection; severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease within 12 weeks of first dose; tuberculosis without treatment and/or positive tuberculin reaction without known vaccination with the bacilli Calmette-Guerin vaccine (BCG). Refer to Section 7.2.2 for further clarification. significant trauma or major surgery within 8 weeks of first dose of study medication; alcohol abuse with less than 24 weeks of sobriety; drug abuse within 3 years of study start. 4. Subjects who present with: a positive CCR5∆32 mutation ? Waived for entry into the Safety/PK Component; a history of postural hypotension or a screen finding of postural hypotension (with or without symptoms) defined as either a systolic BP drop >20 mm Hg, or diastolic BP drop >10 mm Hg and/or drop in systolic BP to <90 mm Hg as described in Section 7.2.1; any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy); New York Heart Association (NYHA) Class III-IV congestive heart failure requiring treatment; Mean QTc interval >450 msec; infection with HIV or Hepatitis B or C, or evidence of any current active infection; a history of cancer and in remission for <3 years excluding subjects with adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. 5. Evidence of organ dysfunction or hematopoietic disorder based on any of the following assessments: hemoglobin <10 gm/dL, hematocrit <32% absolute white blood cell (WBC) count <3.0 × 10(9)/L (<3000/mm3) platelet count <100 × 10(9)/L (<100,000/mm3) AST (serum glutamic-oxaloacetic transaminase [SGOT]) or ALT (serum glutamate pyruvate transaminase [SGPT]) >1.2 × ULN total bilirubin >1.2 X ULN albumin <3.5 g/dL or 35 g/L due to known liver disease estimated glomerular filtration rate (GFR)

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Treatment of rheumatoid arthritis (RA).
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis

Intervention(s)

Product Name: Maraviroc
Product Code: UK-427,857
Pharmaceutical Form: Film-coated tablet
CAS Number: 376348-65-1
Current Sponsor code: UK-427,857
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: To evaluate the effect of maraviroc treatment on patient reported outcomes and disease activity status. Exploratory Investigate the changes in peripheral blood gene expression prior to, during, and following treatment of maraviroc in subjects enrolled in the 12 week Proof-of-Concept (POC) study.

Primary end point(s): The primary endpoint is the American College of Rheumatology 20% (ACR 20) response rate at Week 12.

Main Objective: Proof Of Concept phase of the Protocol: To assess the efficacy of maraviroc (either 150 or 300 mg) versus placebo; both administered BID for 12 weeks in subjects with RA receiving MTX.

Secondary ID(s)

2007-001035-58-ES

A4001056