NL-OMON50283
Completed
Not Applicable
Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis - ASCARA
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 46
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- have a diagnosis of rheumatoid arthritis according to the revised 2010
- •EULAR/ACR criteria for classification of RA
- •\- have a positive test for the presence of anti\-citrullinated protein
- •antibodies (ACPA) in serum as determined by routine clinical assay.
- •\- have adequate hematologic function (ANC \* 4000 cells/µL, platelet count \*
- •150000/µL, and hemoglobin \* 10 g/dL (corresponding to 6\.2 mmol/L)
- •\- have serum creatinine concentrations \< 1\.5 mg/dl and/or a normal creatinine
- •\- be at least 18 years of age
- •\- if a female patient is of childbearing potential, agree to: comply with
- •effective contraceptive measures, use adequate contraception since the last
Exclusion Criteria
- •\- been previously treated with either abatacept and/or methotrexate or
- •another csDMARD
- •\- been previously treated with a kinase inhibitor
- •\- been previously treated with rituximab or another B\-cell depleting agent
- •\- been previously treated with a biological DMARD
- •\- received intra\-articular or systemic glucocorticoid injections or has
- •required treatment for acute RA flare (not being part of a regular therapeutic
- •regimen) within four weeks prior to randomization or requires narcotic
- •analgesics other than those accepted by the investigator for analgesia (e.g.
- •paracetamol, codeine, tramadol)
Outcomes
Primary Outcomes
Not specified
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