Pharmacokinetics and pharmacogenetics of methotrexate in rheumatoid arthritis

Completed

• Conditions: Rheumatoid arthritis; Inflammatory and Immune System - Rheumatoid arthritis

• Registration Number: ACTRN12606000275561
• Lead Sponsor: isa Stamp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

I. Patients with RA (ARA ’87 Criteria, (Arnett et al. 1988). II Methotrexate therapy either as monotherapy or combination therapy for at least three months. The dose of methotrexate must be at a stable dose of 5-20 mg/weekly over the preceding four weeks.III Patients whom the treating Rheumatologist wishes to start or stop MTX.IV Able and willing to give written informed consent and to comply with the requirements of the study.

Exclusion Criteria

I. A change in dose or introduction of another disease modifying anti-rheumatic drug, nonsteroidal anti-inflammatory agent or oral steroid within the preceding month.II. Intra-articular steroid injections within one month prior to enrolment.III. Evidence of serious uncontrolled chronic concomitant disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between Methotrexate polyglutamates and disease activity and or toxicity associated with MTX<br><br>Disease activity assessment<br>Disease activity will be assessed using standard clinical parameters comprising: swollen joint count, tender joint count, physicians global score (visual analogue scale), modified Health Assessment Questionnaire (mHAQ), patient pain and fatigue visual analogue scales, and standardised questions related to side effects from MTX<br><br>This data will be used to calculate a Disease Activity Score (DAS28). Using this validated score patients will be defined as a MTX responder (DAS<3.2) or MTX non-responder (DAS>3.2).<br><br>Laboratory assessment:<br>1. Markers of inflammation - full blood count, erythrocyte sedimentation rate, C-reactive protein <br>2. Assessment of MTX toxicity – full blood count, liver function tests, creatinine<br>3. Intracellular effects of MTX - serum B12, serum and red cell folate[Blood will be collected at each clinic visit]

Secondary Outcome Measures

Name	Time	Method
Association between MTX PGs, response to MTX and genetic polymorphisms of the enzymes involved in MTX metabolism.[One off visit]