EUCTR2005-001086-34-DKActive, not recruitingNot Applicable
A randomised trial of 6 months versus 12 months withdrawal of methotrexate in patients with juvenile idiopathic arthritis in clincal remission - MTX withdrawal study
ISTITUTO GIANNINA GASLINI-PRINTO0 sites200 target enrollmentStarted: August 19, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients will be included at first confirmation of remission on medication, i.e. after clinically documented inactive disease. At the time remission is documented patients may be ONLY on a combination of non-steroidal anti-inflammatory drugs (NSAIDs), and MTX (max 15 mg/m2/week). All the other drugs (eg biologics, steroids etc) must have been withdrawn before this date according to the physician decision; specifically steroid must have been withdrawn at least 1 month before remission is documented and other drugs (biologics, other DMARDs, intraarticular joint injections etc) at least 3 months before remission is documented. At inclusion into this study patients will be considered being in clinically documented remission on medication.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Treatment with steroids in the month before remission is first documented. Treatment with biologics, other DMARDs, intraarticular joint injections etc in the 3 months before remission is first documented
Investigators
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