A randomised trial of 6 months versus 12 months withdrawal of methotrexate in patients with juvenile idiopathic arthritis in clincal remission - MTX withdrawal study
- Conditions
- The present study was designed for the follow up of two groups of patients with JIA, in whom remission was achieved using MTX. In group 1 treatment with MTX will be discontinued as early as 6 months after documentation of remission on medication. In group 2 treatment with MTX will be discontinued later than 12 months after documentation of remission on medication
- Registration Number
- EUCTR2005-001086-34-DK
- Lead Sponsor
- ISTITUTO GIANNINA GASLINI-PRINTO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
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 All the other drugs (eg biologics, steroids etc) must have been withdrawn before this date according to the physician decision; specifically steroid must have been withdrawn at least 1 month before remission is documented and other drugs (biologics, other DMARDs, intraarticular joint injections etc) at least 3 months before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
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
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