Phase 4
N=20
Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis
Granulomatosis With Polyangiitis · Microscopic Polyangiitis
Bottom Line
View on ClinicalTrials.gov: NCT02169219 ↗Enrolled (actual)
20
Serious AEs
55.0%
Results posted
Aug 2018
Primary outcome: Primary: Complete Remission — 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Glucocorticoids (Drug); Rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Remission |
14 | — |
| SECONDARY Disease Response |
20 | — |
| SECONDARY Partial Remission |
20 | — |
| SECONDARY Sustained Complete Remission |
14 | — |
| SECONDARY Limited Flares |
2 | — |
| SECONDARY Severe Flares |
5 | — |
| SECONDARY Early Treatment Failures |
— | — |
| SECONDARY Vasculitis Damage Index (VDI) |
0; 0.5 | — |
Summary
The purpose of this pilot study is to test whether an 8-week course of glucocorticoids, combined with rituximab, is effective in treating ANCA-associated vasculitis.
Eligibility Criteria
Inclusion Criteria
- Patients ages 18-85 years old
- Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus Conference
- New diagnosis or disease flare with a Birmingham Vasculitis Activity Score/Wegener's granulomatosis (BVAS/WG) of > 3
Exclusion Criteria
- Renal disease in patients with PR3-ANCA as defined by any of the following:
- Urinary red blood cell casts
- Biopsy-proven glomerulonephritis
- Increase in serum creatinine of >30% over baseline
- Severe renal disease in patients with MPO-ANCA as defined by both of the following:
- Urinary red blood cell casts or biopsy-proven glomerulonephritis
- Estimated glomerular filtration rate < 30 ml/min/1.73m2
- Diffuse alveolar hemorrhage requiring ventilatory support
- GC treatment for longer than 14 days prior to enrollment unless patient has been on a stable maintenance dose of prednisone at the time of the flare
- Daily oral cyclophosphamide within 1 month prior to enrollment
- Completed a remission induction course of cyclophosphamide or rituximab within 4 months of enrollment
- Hepatitis B infection
- HIV infection
- History of anti-GBM disease
- Other uncontrolled disease, including drug and alcohol abuse, that may interfere with the study
- Pregnancy or breastfeeding
- History of severe allergic reactions to human or chimeric monoclonal antibodies
Data sourced from ClinicalTrials.gov (NCT02169219). 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.