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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept | Experimental | Drug administered to participants with active rheumatoid arthritis |
|
| Adalimumab | Active Comparator | Comparator drug administered to participants with active rheumatoid arthritis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept Injection | Drug | Subjects will be randomized to treatment with either abatacept or adalimumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Visual Analogue Score for Pain | The Visual Analogue Score for Pain is a pain score which has a numerical rating scale from 0 to 10 | 0, 3, 6, 9, 12 months |
| Change in the Neuropathic pain questionnaire: PainDETECT | The painDETECT pain questionnaire is a numerical rated score for neuropathic pain | 0, 3, 6, 9, 12 months |
| Change in Quantitative sensory testing | Quantitative sensory testing measures numerical values for pain in specific regions of testing | 0, 3, 6, 9, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood markers | Pain biomarkers in serum | 0, 3, 6, 9, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof Sofat, MD, PhD | St George's, University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotung Centre for Musculoskeletal Diseases | London | SW17 OPQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38755699 | Derived | Ahmed 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. |
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Published data will be reported in publications from the trial. Data will be shared with other researchers on written request
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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This is a randomized, open label trial
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| Adalimumab Injection | Drug | Subjects will be randomized to treatment with either abatacept or adalimumab |
|
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D007162 | Immunoproteins |