Arthritis prevention with abatacept

Phase 1

• Conditions: The target population for therapeutic intervention will be subjects who carry serum autoantibodies (antibodies to citrullinated protein antigens – ACPA; rheumatoid 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: 20.0Level: PTClassification code 10003239Term: ArthralgiaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-003413-18-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-28
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 206

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.
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

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 clinical trial of medicinal product
• Study Design: Not specified