Oligoarthritis
Conditions
Interventions
Trade Name: Humira
Product Name: Humria
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Recombinant human monocolonal antibody
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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);Main Objective: 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);Secondary Objective: 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) | — |
Countries
United Kingdom
Outcome results
None listed