Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT04255134
Eligibility 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 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
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04255134
Study Brief:
Protocol Section:
NCT04255134