Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)

Sponsor
St George's, University of London
Study ID
NCT04255134
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Abatacept Injection — DRUG
    Subjects will be randomized to treatment with either abatacept or adalimumab
  • Adalimumab Injection — DRUG
    Subjects will be randomized to treatment with either abatacept or adalimumab

Study Details

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.

Key Dates

Start date
Sep 7, 2020
Status verified
May 2023
Primary completion
Oct 26, 2022
Completion
Oct 26, 2022

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Abatacept
    Drug administered to participants with active rheumatoid arthritis
  • Active Comparator: Adalimumab
    Comparator drug administered to participants with active rheumatoid arthritis

Primary Outcome Measure

Change in the Visual Analogue Score for Pain [ Time Frame: 0, 3, 6, 9, 12 months ]

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