Relationship between methotrexate polyglutamates in peripheral red and white blood cells with disease activity: towards optimal methotrexate dosing and route of administration in rheumatoid arthritis.

Conditions: rheumatism
Rheumatoid arthritis
10003816

Registration Number: NL-OMON52447

Lead Sponsor: Overige Centra

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

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

* 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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) MTX-PGs accumulation and MTX-PG distribution profiles in PBMCs and RBC from<br /><br>RA patients following 6 months oral or subcutaneous MTX therapy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>2) Profiles of FPGS pre-mRNA splicing aberrations in PBMCs from RA patients<br /><br>following 6 months MTX therapy.<br /><br>3) Clinical disease parameters, folate levels and impact of MTX on disease<br /><br>activity.<br /><br>4) Validation of a LC-MS/MS based method for MTX-PGs in DBS.</p><br>