Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00104299
• Date of registration: 24/02/2005
• Prospective Registration: No
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis RAVE
• Scientific title: Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI)
• Date of first enrolment: January 2005
• Target sample size: 197
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00104299
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Netherlands, United States

Contacts

• Name: John H. Stone, MD, MPH
• Affiliation: Johns Hopkins University

• Name: Ulrich Specks, MD
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

- Weight of at least 88 pounds(40 kilograms)

- Diagnosis of Wegener's granulomatosis or microscopic polyangiitis according to the
definitions of the Chapel Hill Consensus Conference

- Newly diagnosed patient of Wegener's granulomatosis or microscopic polyangiitis OR
must be experiencing a disease flare characterized by: (a) active disease with a
Birmingham Vasculitis Activity Score for Wegener's granulomatosis (BVAS/WG) of 3 or
greater that would normally require treatment with CYC; OR (b) disease severe enough
to require treatment with CYC; OR (c) must be positive for either PR3-ANCA (ANCA
directed against proteinase 3) or MPO-ANCA (ANCA directed against myeloperoxidase)at
the screening

- Willing to use acceptable forms of contraception for the duration of the study and for
up to 1 year after stopping study medications

- Willing to report pregnancies (female participants or male participants' partners)
occurring at any time during the study and for up to 1 year after stopping study
medications

- Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

- Diagnosis of Churg-Strauss Syndrome according to the definitions of the Chapel Hill
Consensus Conference

- Have limited disease that would not normally be treated with CYC

- Requires mechanical ventilation because of alveolar hemorrhage

- History of severe allergic reactions to human or chimeric monoclonal antibodies

- Active systemic infection

- Have a deep-space infection, such as osteomyelitis, septic arthritis, or pneumonia
complicated by pleural cavity or lung abscess, within 6 months prior to study entry

- History of or current hepatitis B or C infection

- HIV (human immunodeficiency virus) infected

- Acute or chronic liver disease that, in the opinion of the investigator, may interfere
with the study

- History of or active cancer diagnosed within the last 5 years. Individuals with
squamous cell or basal cell carcinomas of the skin and individuals with cervical
carcinoma in situ who have received curative surgical treatment may be eligible for
this study.

- History of anti-glomerular basement membrane (anti-GBM) disease

- Other uncontrolled disease, including drug and alcohol abuse, that may interfere with
the study

- Pregnancy or breastfeeding



Age minimum: 15 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Wegener's Granulomatosis

Vasculitis

Microscopic Polyangiitis

Intervention(s)

Drug: Prednisone

Drug: Cyclophosphamide plus rituximab placebo (control group)

Drug: Azathioprine

Drug: Methylprednisolone (or other glucocorticoid)

Drug: Rituximab plus cyclophosphamide placebo (rituximab group)

Primary Outcome(s)

Disease Remission [Time Frame: 6 months post-randomization]

Secondary Outcome(s)

The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups [Time Frame: 18 months post-randomization]

The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups [Time Frame: 18 months post-randomization]

Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy [Time Frame: Through common close-out (defined as 18 months after the last participant is enrolled in the trial)]

Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups [Time Frame: 18 months post-randomization]

Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization [Time Frame: 6 months post-randomization]

Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups [Time Frame: 18 months post-randomization]

Secondary ID(s)

DAIT ITN021AI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Immune Tolerance Network (ITN)

Genentech, Inc.

Results

• Results available: Yes
• Date Posted: 25/08/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00104299