Phase 4
Completed N=19
Methotrexate Polyglutamate Levels as a Marker for the Clinical Outcome in the Treatment of Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00695188 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcomePrimary: DAS-28 (Disease Activity Score in 28 Joints) — 2.87; 2.66 Units on a Scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DAS-28 (Disease Activity Score in 28 Joints) |
2.87; 2.66 | — |
| SECONDARY HAQ (Health Assessment Questionnaire) |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00695188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.