This is a randomised double-blinded placebo-controlled multi centre study in 98 patients with ACPA positive arthralgia. The study is composed of 2 arms with a 1:1 randomisation at baseline: Treatment phase will be 6 months. Group 1: Abatacept s.c. 125 mg weekly for 6 months vs. Group 2: Placebo s.c. for 6 months. After 6 months both groups will run into the follow up period for another 12 months up to month 18. Patients developing arthritis will be treated according to local guidelines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
98
Klinikum Bad Abbach
Bad Abbach, Germany
Charite Berlin
Berlin, Germany
Praxis für Rheumatologie und Innere Medizin
Berlin, Germany
Clinic Burghausen
Burghausen, Germany
Proportion of patients with an improvement of acute inflammation characterised as improvement of synovitis (synovialitis or tenosynovitis) or osteitis in the MRI of the dominant hand after 6 months of treatment with abatacept or placebo
Time frame: 6 months
RAMRIS synovitis score in the dominant hand 12 and 18 months.
Time frame: 6,12,18 months
Tenosynovitis score in the dominant hand.
Time frame: 6,12,18 months
Proportion of patients with new or persistent arthralgia.
Time frame: 6,12,18 months
Time to disappearance of arthralgia.
Time frame: 6 months
Proportion of patients with clinical arthritis defined by joint swelling
Time frame: 6,12,18 months
Proportion of patients with RA (ACR/EULAR 2010 criteria)
Time frame: 6,12,18 months
Proportion of patients with radiological progress in HR-pQCT analysis comparing baseline image with end of study image.
Time frame: 18 months
Tender Joint Count 68
Time frame: 3,6,9,12,15 and 18 months
Disease activity score (DAS) 28
Time frame: 3,6,9,12,15 and 18 months
Visual analogue scale (VAS) pain
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Krankenhaus Porz Am Rhein
Cologne, Germany
University Clinic Erlangen
Erlangen, Germany
Centrum für innovative Diagnostik und Therapie (Ciri) Rheumatologie/Immunologie
Frankfurt, Germany
Universitätsklinik Freiburg
Freiburg im Breisgau, Germany
Rheumazentrum Ruhrgebiet
Herne, Germany
Time frame: 3,6,9,12,15 and 18 months
Duration of joint stiffness
Time frame: 3,6,9,12,15 and 18 months
Health assessment Questionnaire (HAQ-DI)
Time frame: 6,12 and 18 months
Rheumatoid Arthritis Impact of Disease (RAID)
Time frame: 6,12 and 18 months
Short Form 36 (SF-36)
Time frame: 6,12 and 18 months
Bone mineral density (BMD)
Time frame: 18 months
Bone volume per tissue volume (BV/TV)
Time frame: 18 months
Cortical width in the micro-CT of the distal radius
Time frame: 18 months
Cortical porosity in the micro-CT of the distal radius
Time frame: 18 months
RAMRIS erosion score in the dominant hand 12 and 18 months.
Time frame: 6. 12. 18 months
RAMRIS osteitis score in the dominant hand 12 and 18 months.
Time frame: 6,12,18 months
Swollen Joint Count 68
Time frame: 3,6,9,12,15 and 18 months
Visual analogue scale (VAS) patient global
Time frame: 3,6,9,12,15 and 18 months
Visual analogue scale (VAS) physician global
Time frame: 3,6,9,12,15 and 18 months
Cortical width in the micro-CT of the metacarpal heads
Time frame: 18 months
Cortical porosity in the micro-CT of the metacarpal heads
Time frame: 18 months