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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• MTX-naive

• Age > 18 years

• DAS-28 > 3.2

• American College of Rheumatology-criteria for RA

• Chest-X-ray

• Informed consent

• Prednisolon < 10 mg a day

Exclusion Criteria:

• Pregnancy

• Lactation

• Renal and hepatic impairment

• Malignant diseases (last 5 years)

• Contraindications

• Human Immunodeficiency Virus (HIV), Hepatitis B and C