Clinical trial · Interventional
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
Comparison of Abatacept With Tumor Necrosis Factor Inhibitors in the Treatment of Rheumatoid Arthritis Pain: A Phase IV Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abatacept Injection | Drug | — | UNRESOLVED |
| Adalimumab Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Abatacept
- description
- Drug administered to participants with active rheumatoid arthritis
- interventionNames
- Drug: Abatacept Injection
- type
- ACTIVE_COMPARATOR
- label
- Adalimumab
- description
- Comparator drug administered to participants with active rheumatoid arthritis
- interventionNames
- Drug: Adalimumab Injection
Primary outcomes (3)
- measure
- Change in the Visual Analogue Score for Pain
- timeFrame
- 0, 3, 6, 9, 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAhmed L, Biddle K, Blundell A, Koushesh S, Kiely P, Mein G, Sedgwick P, Sofat N. Assessing the effects of distinct biologic therapies on rheumatoid arthritis pain by nociceptive, neuropathic and nociplastic pain components: a randomised feasibility study. Pilot Feasibility Stud. 2024 May 16;10(1):77. doi: 10.1186/s40814-024-01505-4. PMID 38755699