WEGENT - Comparison of Methotrexate or Azathioprine as Maintenance Therapy for ANCA-Associated Vasculitides
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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) |
Enrollment : | 126 participants |
Allocation: | Randomized |
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 |

- Safety/Efficacy
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients aged over 18 years-old with newly diagnosed systemic Wegener's granulomatosis,
- microscopic polyangitis with at least one factor of poor prognosis according to the five factors score (proteinuria > 1 g/day, renal insufficiency defined as a serum creatininemia > 140 µmol/L, specific cardiomyopathy, gastrointestinal tract and/or CNS involvement).
Exclusion Criteria:
- MPA patients with no poor prognosis factor;
- localized WG;
- relapse of previously known WG or MPA;
- treatment with corticosteroids for more than 1 month prior to diagnosis and start of immunosuppressant;
- co-existence of another multi-system autoimmune disease;
- malignancy (unless considered in complete remission and with no therapy for at least 3 years);
- contra-indication to corticosteroids or study immunosuppressants; pregnancy or no use of contraception in non-menopaused women;
- infection with human immunodeficiency virus; mental or physical disturbances not permitting to give consent.

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
France | |
Christian PAGNOUX | |
Paris, France, 75 |
Principal Investigator: | Jean-François CORDIER, MD | Hospices Civils de Lyon |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00349674 History of Changes |
Other Study ID Numbers: |
97.129 |
First Posted: | July 7, 2006 Key Record Dates |
Last Update Posted: | October 10, 2007 |
Last Verified: | October 2007 |
Keywords provided by Hospices Civils de Lyon:
Wegener's granulomatosis, microscopic polyangiitis, ANCA-associated vasculitis, methotrexate, azathioprine |
Additional relevant MeSH terms:
Vasculitis Granulomatosis with Polyangiitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Vascular Diseases Cardiovascular Diseases Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Systemic Vasculitis Autoimmune Diseases Immune System Diseases Methotrexate Azathioprine Abortifacient Agents, Nonsteroidal |
Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |