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: 20.0 Level: PT Classification code 10003239 Term: Arthralgia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Abatacept
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
University Hospital Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) RAMRIS synovitis, erosion and osteitis scores in the dominant hand 2)Tenosynovitis score in the dominant hand 3) Proportion of patients with new or persistent arthralgia 4) Time to disappearance of arthralgia 5) Proportion of patients with clinical arthritis defined by joint swelling 6) Proportion of patients with RA (ACR/EULAR 2010 criteria) 7) Proportion of patients with radiological progress in HR-pQCT analysis comparing baseline image with end of study image. 8) TJC 68 and SJC 66 9) DAS28 10) VAS pain, VAS patient global, VAS physician global 11) Duration of joint stiffness 12) HAQ-DI 13) RAID score 14) SF-36 score 15) Bone mineral density (BMD), bone volume per tissue volume (BV/TV), cortical width and cortical porosity in the micro-CT of the distal radius and metacarpal heads 16) Gut microbiota composition for patients in the gut microbiota substudy ;Timepoint(s) of evaluation of this end point: 1, 2, 4, 5, 11, 12, 13: After 6, 12, and 18 months 3: In the first 6 months 6, 14: At the end of study (after18 months) 7, 8, 9, 10: After 3, 6, 9, 12, 15 and 18 months 16: After 6 and 12 months | — |
Countries
Brazil, Czech Republic, Germany, Spain
Contacts
Public ContactLead Clinical Physician
Universitätsklinikum Erlangen - Medizinische Klinik 3
Outcome results
None listed