A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 when Administered Concomitantly with Methotrexate
- Conditions
- Rheumatoid Arthritis
- Registration Number
- EUCTR2006-004715-22-SI
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1. Subjects must be male or female, 18 to 75 years of age (inclusive)
2. Have a previously established diagnosis of RA as defined by the ACR revised criteria
3. Have active RA = 6 months in duration as defined by the ACR revised criteria for RA with total disease duration >6 months and not exceeding 10 years 4. CRP =1.0 mg/dL
5. Have a swollen joint count of =6 out of 28 joints and tender joint count of =9 out of 28 joints. Joints that have had prior surgery are to be excluded from the joint count.
6. Must have been taking MTX for at least 6 months and have been on a stable dose of MTX 12.5 to 20 mg weekly for =4 weeks prior to Study Day 1. The MTX dose must remain stable throughout the study; unless downward modification is required for safety reasons. Change in the route of administration is not permitted during the study.
7. No concurrent DMARD treatment (other than a stable dose of MTX); DMARD treatment must have been discontinued =6 months prior to randomization
8. Subjects receiving a nonsteroidal antiinflammatory drug (NSAID) and/or prednisone (=10 mg/day) must have been treated at a stable dose(s) for = 1 month prior to randomization. Subjects may only be taking 1 NSAID.
9. All subjects must agree to use 2 methods of contraception, including 1 barrier method (i.e., a condom or diaphragm plus spermicide), during the treatment period and for 8 weeks after the completion of study drug (unless the subject is of documented non childbearing potential)
10. Female subjects must have a negative pregnancy test (ß-hCG) at screening before the first dose of study drug
11. Must be an outpatient at the time of enrollment
12. Provide informed consent to participate in the study
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
1. Pregnant women or nursing mothers
2. Male subjects with female partners that are pregnant, nursing, or planning to become pregnant during the study or within 30 days of the last dose of VX-702 3.Female subjects of childbearing potential who are not using adequate contraception (defined as use of a barrier method with spermicidal jelly or intrauterine device)
4. Have clinically significant abnormalities in prestudy clinical examination or in prestudy laboratory test results (including the presence of either hepatitis B surface antigen, hepatitis C virus antibody, or HIV antibody)
5. Requires use of medications that may interfere with study evaluations
6. Have any of the following concurrent medical conditions:
• Uncontrolled diabetes or uncontrolled ischemic heart disease
• Substantial renal impairment (creatinine clearance <40mL/min, calculated using the Cockcroft-Gault formula
• History of cancer (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for >3 years)
• History of liver disease
• A prolongation of QTc interval (Fridericia correction), specifically QTc interval >450 ms in males or >480 ms in females
• History of Torsade de Pointes or other significant arrhythmia or additional risk factors for Torsade de Pointes
• Significant active infectious disease requiring systemic antimicrobial treatment, with the exception of uncomplicated bacterial cystitis in women
• Evidence of tuberculosis on chest radiograph without documented adequate anti-TB treatment or known positive tuberculin skin test as follows: Subjects with =10 mm induration; unless completed adequate anti-TB prophylaxis documented prior to study entry and a negative chest radiograph within 6 months of study entry or unless BCG vaccination received and a negative chest radiograph within 6 months of study entry Subjects with >5mm and <10mm induration; unless a negative chest radiograph within 6 months of study entry or unless BCG vaccination received and a negative chest radiograph within 6 months of study entry
• Any other concurrent condition which, in the opinion of the investigator, would preclude participation in or interfere with compliance with the protocol 7 Have elevation in liver function parameters at the Grade 1 toxicity level or higher (i.e., >1.5 x the upper limit of normal [ULN] for alanine aminotransferase [ALT], aspartate aminotransferase [AST], or total bilirubin)
8. Use of concomitant medications that are known to prolong the QTc interval
9. Have previously taken chlorambucil or cyclophosphamide
10. Have been treated with intra-articular injections of corticosteroids within 28 days prior to Day 1
11. Have undergone or are undergoing treatment with another investigational drug or approved treatment for investigational use within 1 month prior to randomization 12. Have planned major surgery (e.g., joint replacement) within the duration of the treatment period of the study
13. Have previously participated in any study with VX-702, unless duration of administration was =1 week and the subject did not discontinue from the study due to an AE
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method