Biologics for RA Pain ( BIORA-PAIN)

Phase 1

• Conditions: Rheumatoid arthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-004468-23-GB
• Lead Sponsor: St George's, University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-26
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified