At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 19 enrolled
Drug / intervention
methotrexate +1 moredrug
Likely dose
methotrexate 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Methotrexate Polyglutamate Levels as a Marker for the Clinical Outcome in the Treatment of Rheumatoid Arthritis A Multicenter, Randomized, Double-blind, Controlled Phase IV Trial
Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation·interventional·Posted Jun 11, 2008·Updated Feb 17, 2011
In Brief
A Phase 4 clinical trial evaluating methotrexate for Rheumatoid Arthritis. Completed, enrolled 19 participants across 2 sites.
Detailed Summary
The primary objective is to determine whether erythrocyte polyglutamate levels are associated with objective clinical response in patients with rheumatoid arthritis after oral administration of low-dose methotrexate.The secondary aim of this study is to compare the efficacy and safety of standard dose methotrexate versus a higher starting dose.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustria
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2008
First PostedJun 2008
Primary CompletionDec 2010
TodayJul 2026
First PostedJun 11, 2008
Enrollment StartMay 1, 2008
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.1 years ago
Interventions
methotrexatedrug
oral administration Escalating dose (15, 20, 25 mg)
methotrexatedrug
25 mg oral administration