Topic: Musculoskeletal disorders
Conditions
Interventions
Participants will be randomised into one of two arms:
1. Abatacept
2. Matching placebo
Participants will receive weekly injections of 125 mg/ml of abatacept or placebo, starting from baseline (week
Sponsors
Guy's and St Thomas' NHS Foundation Trust
King’s College London
Eligibility
Sex/Gender
All
Inclusion 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to development of clinical synovitis or RA | — |
Secondary
| Measure | Time frame |
|---|---|
| The development of RA according to the ACR/EULAR 2010 criteria | — |
Countries
England, Netherlands, United Kingdom
Contacts
Public ContactMarianna Jasenecova
Outcome results
None listed