Advanced Therapeutics in Rheumatoid Arthritis (RA)

RAJP0001

This study will evaluate the retention rates of two advanced therapies, Tumour Necrosis Factor (TNF) and Janus kinase inhibitor (JAK) in the treatment of adults with Rheumatoid Arthritis (RA) over a two year period. It will also examine the ability to embed a clinical trial in a clinical situation using an electronic medical record (EMR).

2020-03-01

2025-03-01

2025-03-01

Recruiting

Early phase I

144

Inclusion Criteria: * patients with RA who meet criteria for obtaining an advanced therapeutic through usual care * active RA with 5 or more swollen joints * seropositive * presence of erosions * failure of methotrexate and hydroxychloroquine and sulfasalazine * failure of Leflunomide -\> or equal to 18 years * able to provide consent * able to attend usual follow up visits Exclusion Criteria: * no contraindication to etanercept or tofacitinib * active serious infection * active Tuberculosis * multiple sclerosis * current cancer * lymphoma ever * previous use of an advanced therapeutic (biologic or JAK kinase inhibitor) * less than 18 years of age * unable to provide consent

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pragmatic, open-label, randomized trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 144, 'type': 'ESTIMATED'}}

2023-10-05