E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
To assess the proportion of patients who achieve clinical remission after 24 weeks of adalimumab and methotrexate (MTX) therapy compared to methotrexate monotherapy in the management of early, persistent oligoarthritis. The defining criteria for clinical remission is absence of tender/swollen joints & CRP< 5mg/ml) |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of the study include the following: 1) the proportion of patients who are in clinical remission (absence of tender/swollen joints & CRP< 5mg/ml) at weeks 12, 24, 36, 48, 72 and 96) 2) assess level of disease activity (DAS score) at weeks 12, 24, 36, 48, 72 and 96 3) proportion of patients with evidence of imaging defined remission at week 48 (ultrasound, plain radiographs and bone densitometry scores) 4) assessment of changes in functional activity levels (using standard assessments of HAQ, EQ-5D, work ability) at weeks 0, 12, 24, 36, 48, 72 and 96 5) To evaluate change in immunological parameters at weeks -2, 0, 12, 24, 36, 48 and 72 (as part of a biological sub-study) |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Biological Sub-study This simply involves biological samples from the main study |
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E.3 | Principal inclusion criteria |
INCLUSION CRITERIA Subjects presenting at the rheumatology clinic who meet all of the following criteria will be considered for enrolment into the study 1. Male and female patients aged between 18 and 80 years. 2. Oligoarthritis defined as inflammatory arthritis affecting ≤ 4 joints 3. At least 1 large joint involvement (wrist, elbow, shoulder, knee or ankle) 4. Disease duration of less than 12 months 5. Patients on NSAIDs must have remained on an unchanged regimen for at least 28 days prior to study drug administration. 6. Patients must be able and willing to comply with the terms of this protocol. 7. Informed consent must be obtained in writing for all subjects at enrolment into the study. EXCLUSION CRITERIA Subjects presenting with any of the following will not be included in the study: 1. Patients who have > 12 months disease duration 2. Exclude if DIP joint alone 3. Evidence of osteoarthritis 4. Diagnosis of gout 5. Previous treatment with a DMARD therapy. 6. Change in NSAID dose within the last 28 days 7. Previous treatment with oral, intra-muscular or intra-articular steroid 8. Patients unwilling or unable to receive adalimumab or MTX or both for the duration of the study. 9. Planned surgery within 12 months of study initiation. 10. Patients with moderate to severe heart failure 11. Suspicion of diagnosis of tuberculosis (positive tuberculosis test (>5mm in duration if previous BCG or >10mm if no previous BCG) or abnormal chest x-ray). |
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E.4 | Principal exclusion criteria |
Subjects presenting with any of the following will not be included in the study: 1. Patients who have > 12 months disease duration 2. Exclude if DIP joint alone 3. Evidence of osteoarthritis 4. Diagnosis of gout 5. Previous treatment with a DMARD therapy. 6. Change in NSAID dose within the last 28 days 7. Previous treatment with oral, intra-muscular or intra-articular steroid 8. Patients unwilling or unable to receive adalimumab or MTX or both for the duration of the study. 9. Planned surgery within 12 months of study initiation. 10. Patients with moderate to severe heart failure |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be number of patients with complete resolution at 24 weeks - Number in remission at 24 weeks (absence of clinical-evidence synovitis (no tender/swollen joints) & CRP< 5mg/ml) |
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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 | Yes |
E.6.4 | Safety | No |
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 | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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 | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
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 | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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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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 | 0 |