Arthritis Prevention In the Pre-clinical Phase of RA with Abatacept.

Phase 2

Completed

Conditions: gewrichsaandoeningen
Arthralgia
Reumatoid Arthritis
10003816

Registration Number: NL-OMON47610

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- 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.

Exclusion Criteria

- 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 4 weeks of inclusion.
- Pregnant or breastfeeding
- Unable to give informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is the time to development of clinical<br /><br>synovitis or RA defined by one of the following methods, whichever is met first:<br /><br>1) The time to development of clinically apparent synovitis in * 3 joints, as<br /><br>determined by two independent assessors with experience in clinical assessment<br /><br>of RA<br /><br>2) The time to development of RA according to the ACR/EULAR 2010 criteria,<br /><br>where joint involvement is defined as joint swelling.<br /><br>In either case joint swelling will be confirmed by ultrasound.</p><br>

Secondary Outcome Measures