Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)

Primary objective To examine: Pain characteristics in participants with active rheumatoid arthritis receiving abatacept biologic therapy versus TNF inhibitor therapy in the form of adalimumab.

To establish if there are differences in pain outcomes by patient reported scores, objective measures of pain using quantitative sensory testing and inflammatory markers in participants receiving biologic therapies for rheumatoid arthritis.

Population: The population being assessed in this study are participants with active rheumatoid arthritis with a disease activity score of greater than 5.1.

Intervention: Subjects will be randomized to treatment with abatacept or adalimumab for active rheumatoid arthritis

Comparison group: Abatacept is being compared to adalimumab therapy in the trial

Inclusion criteria

• Active rheumatoid arthritis causing pain and functional impairment with DAS28 >5.1 -Has already received usual care for inflammatory arthritis including conventional DMARD therapy e.g. methotrexate, sulfasalazine, leflunomide, hydroxychloroquine on stable dose of csDMARD for at least 4 weeks prior to study drug initiation
• Willing to participate in the study over a 12-month period
• Desirably to have positive antibodies to cyclic citrullinated peptide (ACPA/CCP)
• Between 18 and 75 years of age

Exclusion criteria

• Pregnancy or pregnancy planned over next 12 months
• Current or previous unsuccessful use of the biologics abatacept or adalimumab
• Co-existing other autoimmune condition, e.g. systemic lupus erythematosus, -Sjogren's syndrome, connective tissue disease, fibromyalgia, osteoarthritis, gout
• Recent surgery in the last 3 months or imminent surgery in the next 12 months
• Unable to give informed consent
• Previous history of cancer in the last 5 years
• Previous history of multiple sclerosis
• Uncontrolled heart failure, hypertension or diabetes mellitus
• Known history of fibromyalgia or other chronic pain disorder