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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 23 March 2020
Main ID:  EUCTR2019-004468-23-GB
Date of registration: 26/02/2020
Prospective Registration: No
Primary sponsor: St George's, University of London
Public title: Biologics for RA Pain ( BIORA-PAIN)
Scientific title: Comparison of abatacept with tumor necrosis factor inhibitors in the treatment of rheumatoid arthritis pain: A phase IV trial - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
Date of first enrolment: 10/02/2020
Target sample size: 60
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-004468-23
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
United Kingdom
Contacts
Name: Georgia Bullock   
Address:  Cranmer Terrace SW17 ORE London United Kingdom
Telephone: 02087255013
Email: gbullock@sgul.ac.uk
Affiliation:  St George's, University of London
Name: Georgia Bullock   
Address:  Cranmer Terrace SW17 ORE London United Kingdom
Telephone: 02087255013
Email: gbullock@sgul.ac.uk
Affiliation:  St George's, University of London
Key inclusion & exclusion criteria
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 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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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
• females of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation)
• Since the majority of subjects entering into the trial will be taking anchor medication in the form of methotrexate, it is advised that subjects do not conceive during the period of the trial and double contraception is advised at all times during the trial
• Female subjects should not be breastfeeding



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid arthritis
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Intervention(s)

Trade Name: Abatacept
Product Name: Abatacept
Pharmaceutical Form: Injection
INN or Proposed INN: Abatacept
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Concentration unit: mg milligram(s)
Concentration type: equal

Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Injection
INN or Proposed INN: Humira
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)
Main Objective: Rheumatoid arthritis (RA) is a common condition affecting 1-2% of people worldwide. It is a condition that affects the immune system, in which the body attacks it's own joints and tissues. As a result of the inflammation caused, people with RA can experience inflammation, pain and fatigue. Over the last 2 decades, there have been major advances in the treatment of rheumatoid arthritis. The development of new drugs which can target the immune system to slow down or stop the damage to the body caused by RA have been developed. Some of the new treatments being used are antibody, or biologic treatments that are given as regular injections. We have a lot of understanding of how the drug treatments used e.g. adalimumab or abatacept, can control inflammation of the immune system. However, very little is known about how the biologic treatments influence different aspects of pain in RA. Our study will investigate how different biologic treatments, namely adalimumab or abatacept, influence pain
Primary end point(s): Pain outcomes by patient reported scores (VAS and painDETECT) and objective measures of pain using quantitative sensory testing (QST) in people on abatacept versus adalimumab biologic therapies for RA after 12 months’ treatment.
Secondary Objective: In our research group we have developed new techniques to measure pain by examining patients and also performing blood tests. In addition to the pain questionnaires that we collect, we will be investigating whether the pain measurement techniques we use, called quantitative sensory testing (QST and blood testing can help identify distinct features of pain in people with RA.
Secondary Outcome(s)
Secondary end point(s): Blood biomarker levels for pain
Secondary ID(s)
NCT04255134
version3.0
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 10/02/2020
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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