Rheumatoid ArthritisPhase 4BIORA-PAINNCT04255134
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
A Phase 4 study testing Abatacept Injection and Adalimumab Injection in people with Rheumatoid Arthritis, run by St George's, University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Abatacept Injection and Adalimumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Sep 2020to 26 Oct 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Previous history of multiple sclerosis
- Uncontrolled heart failure, hypertension or diabetes mellitus
- Known history of fibromyalgia or other chronic pain disorder
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hotung Centre for Musculoskeletal Diseases
London, SW17 OPQ
About this study
Official title: Comparison of Abatacept With Tumor Necrosis Factor Inhibitors in the Treatment of Rheumatoid Arthritis Pain: A Phase IV Trial
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.
Read the 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
- Conditions
- Rheumatoid Arthritis
- Being tested
- Abatacept Injection, Adalimumab Injection
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abatacept InjectionDrug
Also called Orencia
Subjects will be randomized to treatment with either abatacept or adalimumab
Adalimumab InjectionDrug
Also called Humira
Subjects will be randomized to treatment with either abatacept or adalimumab
| Study group | Role | What they receive |
|---|---|---|
| Abatacept | Experimental | Drug administered to participants with active rheumatoid arthritis Receives: Drug: Abatacept Injection |
| Adalimumab | Active comparator | Comparator drug administered to participants with active rheumatoid arthritis Receives: Drug: Adalimumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 0, 3, 6, 9, 12 months
Change in Quantitative sensory testing
Quantitative sensory testing measures numerical values for pain in specific regions of testing
Measured: 0, 3, 6, 9, 12 months
Secondary outcomes (1)
Change in Blood markers
Pain biomarkers in serum
Measured: 0, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start7 Sep 2020
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Sofat, MD, PhD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255134
- Sponsor's protocol ID
- 2019.0146
- Acronym
- BIORA-PAIN
- Status last verified
- May 2023
- First submitted
- 14 Nov 2019
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Published data will be reported in publications from the trial. Data will be shared with other researchers on written request
Publications
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.
PubMed 38755699
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Abatacept With Tumor Necrosis Factor Inhibitors in the Treatment of Rheumatoid Arthritis Pain: A Phase IV Trial
- ClinicalTrials.gov ID
- NCT04255134
- Acronym / sponsor ID
- BIORA-PAIN / 2019.0146
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abatacept | Experimental | Drug: Abatacept InjectionDrug administered to participants with active rheumatoid arthritis |
| Adalimumab | Active comparator | Drug: Adalimumab InjectionComparator drug administered to participants with active rheumatoid arthritis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abatacept InjectionAlso: OrenciaSubjects will be randomized to treatment with either abatacept or adalimumab | Drug | Abatacept |
| Adalimumab InjectionAlso: HumiraSubjects will be randomized to treatment with either abatacept or adalimumab | Drug | Adalimumab |
Primary outcome
Change in the Visual Analogue Score for Pain
Time frame: 0, 3, 6, 9, 12 months
The Visual Analogue Score for Pain is a pain score which has a numerical rating scale from 0 to 10
Change in the Neuropathic pain questionnaire: PainDETECT
Time frame: 0, 3, 6, 9, 12 months
The painDETECT pain questionnaire is a numerical rated score for neuropathic pain
Change in Quantitative sensory testing
Time frame: 0, 3, 6, 9, 12 months
Quantitative sensory testing measures numerical values for pain in specific regions of testing
1 secondary outcome
Change in Blood markers
Time frame: 0, 3, 6, 9, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Derived from this study: PubMed 38755699Ahmed 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.
- Individual participant dataSharing planned: No. Published data will be reported in publications from the trial. Data will be shared with other researchers on written request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Sofat, MD, PhD principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abatacept Injection and Adalimumab Injection in people with Rheumatoid Arthritis, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Visual Analogue Score for Pain (time frame: 0, 3, 6, 9, 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04255134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.