Status:
COMPLETED
Methotrexate Polyglutamate Levels as a Marker for the Clinical Outcome in the Treatment of Rheumatoid Arthritis
Lead Sponsor:
Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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-do...
Detailed Description
The folate antagonist methotrexate (MTX) is currently one of the most widely used drugs for the treatment of rheumatoid arthritis (RA).Although MTX is very effective and well tolerated, the major draw...
Eligibility Criteria
Inclusion
- 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
- Pregnancy
- Lactation
- Renal and hepatic impairment
- Malignant diseases (last 5 years)
- Contraindications
- Human Immunodeficiency Virus (HIV), Hepatitis B and C
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00695188
Start Date
May 1 2008
End Date
December 1 2010
Last Update
February 17 2011
Active Locations (2)
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1
Kaiser-Franz-Josef-Spital
Vienna, Austria, 1100
2
Rheumazentrum Wien Oberlaa
Vienna, Austria, 1100