Arthritis prevention with abatacept
- Conditions
- The target population for therapeutic intervention will be subjects who carry serum autoantibodies (antibodies to citrullinated protein antigens – ACPArheumatoid factor – RF) and who have joint pains (arthralgia) but no joint swelling. These subjects are deemed to be at highest risk of developing rheumatoid arthritis.MedDRA version: 20.0 Level: PT Classification code 10003239 Term: Arthralgia System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2013-003413-18-GB
- Lead Sponsor
- King’s College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 206
- Male or female subjects, aged = 18 years.
- Arthralgia that is considered to be inflammatory in nature.
- ACPA and RF positive, or high titre ACPA.
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 206
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 206
- Clinically apparent arthritis, as assessed by a rheumatologist.
- A history of inflammatory arthritis, as assessed by a rheumatologist.
- History or current use of DMARDs or biologics.
- History of oral or parenteral use of corticosteroids within the last 12 weeks.
- Co-morbidities requiring treatment with immunosuppressive or immune modulating therapy.
- Chronic illnesses that would, in the opinion of the investigator, put the subject at risk.
- Recipients of a live vaccine within 3 months of inclusion.
- Pregnant or breastfeeding
- Unable to give informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Every 3 months for up to 24 months;Main Objective: To evaluate the feasibility, efficacy and acceptability of abatacept therapy in subjects at high risk of developing RA.;Secondary Objective: To characterise immune and inflammatory responses associated with ACPA before, during and after therapy with abatacept.;<br> Primary end point(s): 1) The time to development of clinically apparent synovitis in = 3 joints, as determined by two independent assessors with experience in clinical assessment of RA<br> 2) The time to development of RA according to the ACR/EULAR 2010 criteria, where joint involvement is defined as joint swelling.<br> In either case joint swelling will be confirmed by ultrasound.<br>
- Secondary Outcome Measures
Name Time Method