Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT04255134
Status:
COMPLETED
Last Update Posted:
2023-05-18
First Post:
2019-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
Sponsor:
St George's, University of London
Organization:
Study Overview
Official Title:
Comparison of Abatacept With Tumor Necrosis Factor Inhibitors in the Treatment of Rheumatoid Arthritis Pain: A Phase IV Trial
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIORA-PAIN
Brief Summary:
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.
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.
Detailed 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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: