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 mpnths 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 has the main goal to find out if methotrexate could be safely stopped after 6 months or if it is betterto 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 for at least 3 months (no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; no elevation in ESR or/and CRP attributable to JIA; physician’s global assessment of disease activity indicates no disease activity) (23). At times -3 months patients may be ONLY on a combination of non-steroidal anti-inflammatory drugs (NSAIDs), low-dose steroids (0.2 mg/kg/day or 10 mg/day whichever is lower), and MTX (max 15 mg/m2/week); all the other drugs (eg biologics) must have been withdrawn before this date according to the physician decision. 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 definition of remission: 1. No joints with active arthritis 2. No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; 3. No active uveitis (to be defined); 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 | Yes |
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 deicisions. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |