Prospective, Single-centre, Double-Blind, Randomised, Placebo-controlled Study Evaluating Efficacy of Adalimumab + Methotrextate Compared with Placebo + Methotrexate in Patients with Early Oligoarthritis - ADEOS - ADalimumab in persistent Early Oligoarthrits Study

Phase 1

Active, not recruiting

• Conditions: Oligoarthritis

• Registration Number: EUCTR2008-004877-17-GB
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-30
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 30

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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified