Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept | Active Comparator | Abatacept 125 mg s.c. weekly |
|
| Placebo | Placebo Comparator | Placebo (NaCl 0,9%) s.c. weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug | Administration of Abatacept s.c. 125mg/weekly according to the Label for Rheumatoid arthritis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| RAMRIS synovitis score in the dominant hand 12 and 18 months. | 6,12,18 months | |
| Tenosynovitis score in the dominant hand. | 6,12,18 months | |
| Proportion of patients with new or persistent arthralgia. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Georg Schett, Prof. Dr. univ. | University Clinic Erlangen, Department of Internal Medicine 3, Rheumatology & Immunology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Bad Abbach | Bad Abbach | Germany | ||||
| Charite Berlin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Administration of the comparator s.c. weekly in comparable to verum |
|
|
| 6,12,18 months |
| Time to disappearance of arthralgia. | 6 months |
| Proportion of patients with clinical arthritis defined by joint swelling | 6,12,18 months |
| Proportion of patients with RA (ACR/EULAR 2010 criteria) | 6,12,18 months |
| Proportion of patients with radiological progress in HR-pQCT analysis comparing baseline image with end of study image. | 18 months |
| Tender Joint Count 68 | 3,6,9,12,15 and 18 months |
| Disease activity score (DAS) 28 | 3,6,9,12,15 and 18 months |
| Visual analogue scale (VAS) pain | 3,6,9,12,15 and 18 months |
| Duration of joint stiffness | 3,6,9,12,15 and 18 months |
| Health assessment Questionnaire (HAQ-DI) | 6,12 and 18 months |
| Rheumatoid Arthritis Impact of Disease (RAID) | 6,12 and 18 months |
| Short Form 36 (SF-36) | 6,12 and 18 months |
| Bone mineral density (BMD) | 18 months |
| Bone volume per tissue volume (BV/TV) | 18 months |
| Cortical width in the micro-CT of the distal radius | 18 months |
| Cortical porosity in the micro-CT of the distal radius | 18 months |
| RAMRIS erosion score in the dominant hand 12 and 18 months. | 6. 12. 18 months |
| RAMRIS osteitis score in the dominant hand 12 and 18 months. | 6,12,18 months |
| Swollen Joint Count 68 | 3,6,9,12,15 and 18 months |
| Visual analogue scale (VAS) patient global | 3,6,9,12,15 and 18 months |
| Visual analogue scale (VAS) physician global | 3,6,9,12,15 and 18 months |
| Cortical width in the micro-CT of the metacarpal heads | 18 months |
| Cortical porosity in the micro-CT of the metacarpal heads | 18 months |
| Berlin |
| Germany |
| Praxis für Rheumatologie und Innere Medizin | Berlin | Germany |
| Clinic Burghausen | Burghausen | Germany |
| Krankenhaus Porz Am Rhein | Cologne | Germany |
| University Clinic Erlangen | Erlangen | 91054 | Germany |
| Centrum für innovative Diagnostik und Therapie (Ciri) Rheumatologie/Immunologie | Frankfurt | 60528 | Germany |
| Universitätsklinik Freiburg | Freiburg im Breisgau | Germany |
| Rheumazentrum Ruhrgebiet | Herne | Germany |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |