Arthritis Prevention In the Pre-clinical Phase of Rheumatoid Arthritis with Abatacept
- Conditions
- Topic: Musculoskeletal disordersSubtopic: Musculoskeletal (all Subtopics)Disease: MusculoskeletalMusculoskeletal Diseases
- Registration Number
- ISRCTN46017566
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 213
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
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
11. Subjects with tuberculosis (including those at high risk of tuberculosis), chronic viral infections, recent serious bacterial infections, or subjects receiving live vaccinations within 3 months of the anticipated first dose of study medication, or those with chronic illnesses that would, in the opinion of the investigator, put the patient at risk
12. Subjects who currently abuse drugs or alcohol
13. Subjects who are pregnant or who are breastfeeding
14. Male subjects or women of childbearing potential not willing to use adequate contraception during the period of IMP dosing and for up to 10 weeks after the last dose of study drug
15. Subjects with abnormal laboratory tests, as defined in the study protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to development of clinical synovitis or RA
- Secondary Outcome Measures
Name Time Method The development of RA according to the ACR/EULAR 2010 criteria