Phase 3
N=197
Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis
Vasculitis · Wegener's Granulomatosis · Microscopic Polyangiitis
Bottom Line
View on ClinicalTrials.gov: NCT00104299 ↗Enrolled (actual)
197
Serious AEs
54.3%
Results posted
Aug 2011
Primary outcome: Primary: Disease Remission — 63; 52 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rituximab plus cyclophosphamide placebo (rituximab group) (Drug); Cyclophosphamide plus rituximab placebo (control group) (Drug); Azathioprine (Drug); Methylprednisolone (or other glucocorticoid) (Drug); Prednisone (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Remission |
63; 52 | <0.001 sig |
| SECONDARY Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy |
2; 2; 7; 23; 4; 1 | 0.927 |
| SECONDARY Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization |
62; 51 | 0.133 |
| SECONDARY The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups |
243; 230; NA; NA; NA; NA | 0.761 |
| SECONDARY The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups |
246; 168; NA; NA; NA; NA | 0.861 |
| SECONDARY Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups |
30; 29; 57; 43; 119; 112 | 0.497 |
| SECONDARY Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups |
176; 177; 180; 183; 189; 266 | 0.147 |
Summary
Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating patients with WG and MPA.
Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce disease remission by Month 6.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00104299). 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.