Clinical Trial: Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia (ARIAA)
Brief Summary: 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.
Detailed Summary:
Sponsor: University of Erlangen-Nürnberg Medical School
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 [ 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 ]
Original Secondary Outcome:
- RAMRIS synovitis, erosion and osteitis scores 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 ]
- TJC 68 and SJC 66 [ Time Frame: 3,6,9,12,15 and 18 months ]
- DAS28 [ Time Frame: 3,6,9,12,15 and 18 months ]
- VAS pain, VAS patient global, VAS physician global [ Time Frame: 3,6,9,12,15 and 18 months ]
- Duration of joint stiffness [ Time Frame: 3,6,9,12,15 and 18 months ]
- HAQ-DI [ Time Frame: 6,12 and 18 months ]
- RAID [ Time Frame: 6,12 and 18 months ]
- 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 and metacarpal heads [ Time Frame: 18 months ]
- Cortical porosity in the micro-CT of the distal radius and metacarpal heads [ Time Frame: 18 months ]
Information By: University of Erlangen-Nürnberg Medical School
Dates:
Date Received: February 2, 2015
Date Started: November 2014
Date Completion: December 2018
Last Updated: May 20, 2016
Last Verified: May 2016