Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia

Phase 1

• Conditions: Patients with ACPA (anti citrullinated peptide antibodies) positive arthralgia and OMERACT RAMRIS synovitis (synovialitis or tenosynovitis) or osteitis but without clinical arthritis, defined by joint swelling; 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: EUCTR2014-000555-93-DE
• Lead Sponsor: niversity Hospital Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-26
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

- Females and males aged =18 years at time of consent
- ACPA (with or without RF)
- Joint pain (hand, feet, knee, shoulder or elbow) present for at least 6 weeks prior to inclusion or in past history
- Presence of synovitis (synovialitis or tenosynovitis) or osteitis in MRI of the dominant hand at baseline
- Must understand and voluntarily sign an informed consent form including written consent for data protection
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 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

- Presence of arthritis in hand, feet, knee, shoulder or elbow joints defined as swelling
- Current treatment with glucocorticoids conventional or biologic DMARDs
- Any other autoimmune or inflammatory disease such as SLE, PSS, MCTD, SpA, Behcet disease, vasculitis or autoimmune hepatitis.
- Any malignancy in the last 5 years
- Chronic infection such as latent TB, (TB not adequately treated according to guidelines), or hepatitis B or C infection
- Immunocompromised patients or patients known to be HIV positive
- Uncontrolled severe concomitant disease
- Pregnant or lactating females
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To explore whether subclinical MRI inflammatory lesions are reduced in a higher proportion of ACPA positive arthralgia patients treated with abatacept s.c. 125mg/week than placebo after 6 months.;Secondary Objective: To describe the evolution of clinical and radiological parameters (MRI and HR-pQCT) in patients with ACPA positive arthralgia treated with abatacept s.c. or placebo for 6 months. ;Primary end point(s): Proportion of patients with an improvement of synovitis (synovialitis or tenosynovitis) or osteitis in the MRI of the dominant hand as measured using the OMERACT-RAMRIS score and the tenosynovitis score (change > 0 in the sum of RAMRIS osteitis and synovitis score and tenosynovitis score).;Timepoint(s) of evaluation of this end point: After 6 months of treatment with abatacept or placebo