rheumatism Rheumatoid arthritis
Conditions
Interventions
None listed
Sponsors
Overige Centra
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults Diagnosed with rheumatoid arthritis Able to read Dutch texts (only prednisolone (and/or triamcinolonacetonide i.a./i.m.) is allowed as co-medication and no other DMARDs)
Exclusion criteria
Exclusion criteria: * Rheumatic autoimmune disease other than RA, e.g., systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis * Subjects who have received an investigational drug within 30 Days prior to the screening visit, known sensitivity to any component of the study drug or previous hypersensitivity reaction or other clinically significant reaction to s.c. medications, any clinically significant hepatic, renal, cardiac, pulmonary, gastrointestinal, metabolic or endocrine disturbances, other medical or psychiatric condition, or clinically relevant abnormal values on any investigation, which in the opinion of the investigator, could make the subject unsuitable for the study, could compromise subject safety, limit the subject*s ability to complete the study, and/or compromise the objectives of the study. History of substance abuse or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) MTX-PGs accumulation and MTX-PG distribution profiles in PBMCs and RBC from RA patients following 6 months oral or subcutaneous MTX therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2) Profiles of FPGS pre-mRNA splicing aberrations in PBMCs from RA patients following 6 months MTX therapy. 3) Clinical disease parameters, folate levels and impact of MTX on disease activity. 4) Validation of a LC-MS/MS based method for MTX-PGs in DBS. | — |
Countries
Netherlands
Outcome results
None listed