The feasibility and pharmacokinetic study of using loading dose methotrexate in rheumatoid arthritis patients.

Phase 1

Recruiting

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

• Registration Number: ACTRN12623000420640
• Lead Sponsor: Central Adelaide Local Health Network Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-28
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients attending the rheumatology clinic at the Central Adelaide Local Health Network (CALHN) who have active rheumatoid arthritis and for whom the decision has been made to commence methotrexate (and sulfasalazine and hydroxychloroquine) as triple DMARD therapy.
The decision to use methotrexate is not part of this trial. It will be made according to clinical need and according to our standardised inclusion criteria for commencement of methotrexate therapy. These include:
1) ALT < 2x ULN
2) Calculated Creatinine Clearance > 60 mL/min (Cockcroft-Gault)
3) Neutrophils within normal range
4) If a smoker, Pulmonary Function Tests will be conducted, and they must have FVC>70% predicted and DLCO> 60% predicted
5) At least 5 years since treatment for a malignancy (except non-melanoma skin cancers)
6) Not pregnant (test is done as standard prior to MTX commencement)
7) Able to read English and/or good communication skills.
8) Age greater than or equal to 18 years

Exclusion Criteria

1) BMI < 18 because sub-cutaneous injections of MTX will be used in the loading dose group. An upper BMI was discussed but there is no apparent reason for specifying an upper limit.
2) Age > 85 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified