A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RA
- Conditions
- RHEUMATOID ARTHRITIS
- Registration Number
- EUCTR2004-001930-18-EE
- Lead Sponsor
- CombinatoRx, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
•Subject must be at least 18 years of age.
•Have rheumatoid arthritis.
•Have at least 3 swollen joints (max = 28) and 3 tender joints (max = 28).
•Subject must have baseline C-reactive protein levels of at least 2.2 mg/L and a DAS28 score greater than 4.5.
•Subject must have been on DMARD therapy for at least 3 months and be on a stable dose of DMARD therapy for at least 28 days prior to enrollment.
•Subject must have voluntarily signed the informed consent
Are the trial subjects under 18?
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
•Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (barriers or abstinence). Female subjects using hormonal birth control are not to be enrolled.
•Subject is currently taking any steroids (glucocorticoids). All glucocorticoids must be discontinued for at least one month prior to entering study. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study.
•Subject is currently taking more than 81 mg of aspirin daily.
•Subject is currently taking a statin, unless she/he has been on a stable dose of the same statin for at least 3 months prior to entering into the trial.
•Subject has any active infections or recent surgical procedures within 30 days of study initiation.
•Subject has uncontrolled diabetes mellitus as defined by a HbA1C value = 7.0%.
•Subject knowingly has HIV or Hepatitis.
•Subject has undergone administration of any investigational drug within 30 days of study initiation.
•Subject has a history of hypersensitivity to steroids and/or dipyridamole.
•Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Compare the reduction in CRP levels between subjects treated with CRx-102 plus DMARD therapy and subjects treated with placebo plus DMARD therapy. ;Main Objective: •Compare the response of CRx-102 plus DMARD therapy to placebo plus DMARD therapy in lowering CRP levels in rheumatoid arthritis subjects.;Secondary Objective: •Evaluate the changes in inflammatory cytokines in subjects treated with CRx-102 plus DMARD therapy to placebo plus DMARD therapy.<br><br>•Evaluate the efficacy of CRx-102 plus DMARD therapy to placebo plus DMARD therapy using ACR-20 and DAS28 indices as well as fatigue scales.<br><br>
- Secondary Outcome Measures
Name Time Method