E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This study which has the main goal to find out if methotrexate could be safely stopped after 6 months or if it is better to stop after 12 months of continuous clinical remission. |
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E.2.2 | Secondary objectives of the trial |
Evaluate whether methotrexate therapy should be continued, and how long for, even in the absence of any symptoms. Identify risk factors that enable to predict the relapses of the disease |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 All the other drugs (eg biologics, steroids etc) must have been withdrawn before this date according to the physician decision; specifically steroid must have been withdrawn at least 1 month before remission is documented and other drugs (biologics, other DMARDs, intraarticular joint injections etc) at least 3 months before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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Criteria for clinical remission: 1. No joints with active arthritis 2. No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; 3. No active uveitis; 4. No elevation in ESR or/and CRP attributable to JIA (if both are tested, both should be normal); 5. Physician’s global assessment of disease activity indicates no disease activity (i.e. less than VAS scale 1 cm); 6. Clinical Remission On Medication. The criteria for clinical remission must be met for a minimum of six continuous months while the patient is on medication in order for the patient to be considered to be in a state of clinical remission on medication. 7. Clinical remission Off medication: The criteria for clinical remission must be met for a minimum of 12 continuous months while off all anti-arthritis and anti-uveitis medication in order for the patient to be considered to be in a state of clinical remission off medication Definition of flare: Occurrence of any sign of active arthritis and/or active systemic symptoms |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Criteria for a preliminary discontinuation of the study In case of a 30% difference for the likelihood of relapses the study will be discontinued. The superior regime will be proposed as standard for future decisions. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |