ISRCTN46017566
Completed
未知
Arthritis Prevention In the Pre-clinical Phase of Rheumatoid Arthritis with Abatacept: a randomised controlled trial
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Topic: Musculoskeletal disorders
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Enrollment
- 213
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31307535/ protocol (added 05/06/2020) 2024 Results article in https://doi.org/10.1016/S0140-6736(23)02649-1 (added 19/02/2024)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female subjects, aged 18 years or over
- •2\. Arthralgia, defined as non\-traumatic joint pain localised to synovial joints including, but not necessarily confined to, hands, wrists or feet, and in the opinion of the supervising rheumatologist considered to be inflammatory in nature
- •3\. Positive for serum rheumatoid factor (RF) and antibodies to citrullinated protein antigens (ACPA) as defined by local clinical laboratory testing. Subjects who are RF negative, but who carry high levels of serum ACPA (defined as being \= 3 x upper limit of normal \[ULN] for the assay) may be included
- •4\. Able and willing to give written informed consent and comply with the requirements of the study protocol
Exclusion Criteria
- •1\. Previous diagnosis of RA or other form of inflammatory arthritis including, but not limited to, SLE, psoriatic arthritis, ankylosing spondylitis, gout or pyrophosphate arthopathy, and including current treatment with DMARDs or biological therapy
- •2\. Arthralgia that, in the opinion of the supervising physician, is poorly localised, e.g., pelvic or shoulder girdle pain that is confined to the axial skeleton or entheses, or pain which the physician considers to be due to osteoarthritis or fibromyalgia, or related to other autoimmune conditions such as type I diabetes, coeliac or autoimmune thyroid disease
- •3\. Clinically apparent arthritis, as assessed by a rheumatologist, characterised by soft tissue swelling of one or more synovial joints. Subclinical synovitis, as detected by imaging modalities such as ultrasonography or MRI, is NOT an exclusion criterion
- •4\. A history of oral or parenteral use of corticosteroids within the last 12 weeks used to treat the current episode of musculoskeletal symptoms
- •5\. Co\-morbidities requiring chronic treatment with immunosuppressive or immune\-modulating therapy
- •6\. Subjects who have at any time received treatment with any investigational drug within 28 days
- •7\. A history of acute allergic reactions to biological therapy or immunoglobulins
- •8\. Subjects who are incapable of completing study\-related assessments or give informed consent
- •9\. Subjects with current symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic or cerebral disease, whether or not related to RA and which, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study
- •10\. Subjects with a cancer history within the last 5 years
Outcomes
Primary Outcomes
Not specified
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