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Methotrexate Polyglutamate Levels as a Marker for the Clinical Outcome in the Treatment of Rheumatoid Arthritis

NCT00695188 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2011-02-17

Study results available
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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.

Conditions

Interventions

DRUG

methotrexate

oral administration Escalating dose (15, 20, 25 mg)

DRUG

methotrexate

25 mg oral administration

Sponsors & Collaborators

  • Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation

    lead OTHER

Principal Investigators

  • Hans Broell, Prof. Dr. · Ludwig-Boltzmann-Institut fuer Rheumatologie und Balneologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00695188 on ClinicalTrials.gov