WEGENT - Comparison of Methotrexate or Azathioprine as Maintenance Therapy for ANCA-Associated Vasculitides
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|ClinicalTrials.gov Identifier: NCT00349674|
Recruitment Status : Unknown
Verified October 2007 by Hospices Civils de Lyon.
Recruitment status was: Active, not recruiting
First Posted : July 7, 2006
Last Update Posted : October 10, 2007
|Condition or disease||Intervention/treatment||Phase|
|Systemic Wegener's Granulomatosis||Drug: Azathioprine: 2 mg/kg/day Drug: methotrexate 0.3 mg/kg/week, to a maximum and optimal dose of 25 mg/week||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of ANCA-Associated Vasculitides : Corticosteroids and Pulse Cyclophosphamide Followed by Maintenance Therapy With Methotrexate or Azathioprine: a Prospective Multicenter Randomized Trial|
|Study Start Date :||January 1999|
- Frequency of severe adverse events in each arm. Hypothesis based upon NIH data was a rate of 6% severe adverse event with methotrexate compared to 30% with azathioprine (24% in one study on RA and 46% in one study on Sjögren syndrome).
- Evaluation was planned after the last included patient has completed the assigned trial regimen (after 12 months of maintenance regimen or because of drug withdrawal).
- Relapse-free survival rate.
- Cumulative event-free survival rate (adverse event- and relapse-free survival rate).
- Health quality assessment using HAQ and SF36.
- Efficacy of induction therapy with pulsed cyclophosphamide.
- Second evaluation of the same outcome parameters is planned 5 years after the last included patient has completed the assigned trial regimen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349674
|Paris, France, 75|
|Principal Investigator:||Jean-François CORDIER, MD||Hospices Civils de Lyon|