drugset / Trial / NCT00695188
Methotrexate Polyglutamate Levels as a Marker for the Clinical Outcome in the Treatment of Rheumatoid Arthritis
Phase 4
Completed
19 enrolled
Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2008-05
- Primary completion
- 2010-12
- Completion
- 2010-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Methotrexate | Small molecule | 15 mg | Oral |
| Comparator | Methotrexate | Small molecule | 20 mg | Oral |
| Comparator | Methotrexate | Small molecule | 25 mg | Oral |