Tocilizumab and Remission in early rheumatoid arthritis

Phase 1

• Conditions: Rheumatoid Arthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-004017-17-GB
• Lead Sponsor: The University of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1.Diagnosis of rheumatoid arthritis (2010 ACR/EULAR RA classification criteria) 2.Symptom duration =12months 3. No previous disease modifying anti-rheumatic drug (DMARD) therapy 4. Active RA at baseline (defined as: DAS28 = 3.2) 5. Active hand and/or wrist joint evaluable by US and MRI (with no planned surgery during the study period) 6. Patients without any contraindication to MRI
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Patients unwilling or unable to receive MTX for the duration of the study. 2.Patients with inflammatory joint disease of different origin, mixed connective tissue disease, Reiter’s syndrome, psoriatic arthritis, systemic lupus erythematosis, or any arthritis with onset prior to 16 years of age. 3.Suspicion of diagnosis of tuberculosis: positive quantiferon +/- abnormal chest x-ray – as per clinician judgement. Prior history of TB with confirmed full chemotherapy +/- latent TB adequately treated may be included as per physician’s discretion. 4.Intramuscular, oral or intra-articular (of non-target joint) corticosteroid within 28 days of the screening visit; intra-articular steroid of the chosen target joint within 12 weeks of screening. 5. Patients with serious infections within 3 month of enrolment (screening) or persistent infections. 6. Patients at significant risk of infection (e.g. leg ulceration, indwelling urinary catheter, septic joint within 1 year (or ever if prosthetic joint still in situ). 7. Known positive serology for hepatitis B or C, or HIV

Study & Design

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