Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)

St George's, University of London

Status and phase

Completed

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: Abatacept Injection

Drug: Adalimumab Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04255134

2019.0146

Details and patient eligibility

About

It is increasingly recognized that although suppression of inflammation is a treatment goal in rheumatoid arthritis, many people who have control of their inflammation continue to experience pain. A number of studies have recently shown that by measuring further characteristics of pain in rheumatoid arthritis, e.g. neuropathic pain, quantitative sensory testing, compared with objective measures of inflammation, it is possible to acquire more detailed information about the level of pain in relation to inflammation that a patient with rheumatoid arthritis is experiencing, which could assist in developing their care.

In this study, the investigators will explore validated endpoints for pain including the Visual Analogue Scale for pain, neuropathic pain scores and quantitative sensory testing for pain.

The investigators will evaluate in a population-based study, the pain profile using the Visual Analog Scale (VAS), neuropathic pain assessment, quantitative sensory testing (QST) by pain pressure thresholds (PPT) in comparison to markers of inflammation in order to assess the difference in pain outcomes between baseline pre- and post- treatment in a population of participants with active Rheumatoid Arthritis treated with abatacept and Tumor Necrosis Factor (TNF) inhibitors respectively. All measures will be conducted systematically in the abatacept and TNF inhibitor groups pre- and post-treatment with respective biologic agents. Participants with active Rheumatoid Arthritis who may be eligible for biologic treatment will be screened for enrolment into the study.

Full description

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

Enrollment

18 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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