A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Registration Number
- EUCTR2004-002157-30-DK
- Lead Sponsor
- Takeda Europe R&D Centre Ltd. (TEuR&D)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Men and women, who are capable of understanding and willing to sign the informed consent, are 18 years or older, with a diagnosis of rheumatoid arthritis for at least 6 months with partial response to methotrexate are to be included in this study.
Subjects must have active rheumatoid arthritis using American College of Rheumatology (ACR) criteria (defined as =6 swollen joints and =9 tender joints,
and a CRP =1.2 mg/dL or ESR =28 mm/hr) despite methotrexate therapy.
All subjects must have been treated with methotrexate for at least 6 months and have been on a stable dose for at least 4 weeks prior to the Baseline Visit.
Subjects on non-steroidal anti-inflammatory drugs (NSAIDs) must remain on a stable
dose of their NSAIDs (throughout the study) and subjects on prednisone (or its equivalent) must remain on a stable maintenance dose (throughout the study) not to exceed 10 mg/day.
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
Subjects who have hypersensitivity to TAK-715 or its constituents, with a significant history of uncontrolled hypertension, secondary, non-inflammatory type of arthritis, severe liver disease, or any significant results from physical exams, electrocardiograms (ECGs), chest x-ray, purified protein derivative (PPD) skin test for tuberculosis, or clinical laboratory and diagnostic screening tests as determined by the investigator.
The subject has failed therapy due to lack of efficacy with any anti-TNF agent or 2 or more disease-modifying antirheumatic drugs (DMARDs) other than methotrexate.
Excluded medication are:
• All DMARDs and biologics other than methotrexate used to treat rheumatoid arthritis (including tetracycline when used as a DMARD).
• Tetracyclines cannot be used for any reason during the study.
• All systemic (non-DMARD) immunosuppressants with the exception of prednisone or its equivalent.
• Controlled-release oxycodone (OxyContin?) and other non-NSAID long-acting analgesics.
• Aspirin and aspirin-containing combination products used for analgesia. (Aspirin =325 mg/day for cardiac prophylaxis is permitted.)
• CYP3A4 inhibitors, which include: grapefruit juice, itraconazole, ketoconazole, macrolide antibiotics (not azithromycin) and nefazodone.
• Intra- or peri-articular joint injections are not allowed during the study.
• Any investigational drugs within 30 days prior to enrollment and throughout the trial.
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