Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study

Terminated

• Conditions: Granulomatosis With Polyangiitis; Microscopic Polyangiitis
• Interventions: Other: Observational

• Registration Number: NCT01586858
• Lead Sponsor: Johns Hopkins University

Brief Summary

Rituximab is the first drug approved by the United States Food and Drug Administration (FDA) for the treatment of patients with granulomatosis with polyangiitis (Wegener's granulomatosis) or microscopic polyangiitis. Because it is a relatively new medication, the long-term safety and efficacy of this drug is not yet clear. This study proposes to follow patients who were enrolled in the RAVE study to determine if treatment with rituximab influences long-term outcomes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-25
• Study First Posted: 2012-04-27
• Study Start: 2012-05
• Primary Completion: 2014-05-15
• Study Completion: 2014-05-15
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

1. Enrollment in the RAVE trial
2. Completion of RAVE Common Closeout Date visit
3. Informed consent

Exclusion Criteria

1. Refusal to participate
2. Inability to comply with standard-of-care, including routine clinical visits and testing.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RAVE subjects	Observational	-

Primary Outcome Measures

Name	Time	Method
Long-term safety of rituximab for the treatment of ANCA-associated vasculitis	Four years	To determine the long-term safety of rituximab for the treatment of ANCA-associated vasculitis (granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic polyangiitis).

Secondary Outcome Measures

Name	Time	Method
Disease damage assessed by the increase in Vasculitis Damage Index (VDI)	Four years	The VDI is composed of 11 categories (e.g., musculoskeletal, pulmonary) and 64 individual damage items. The score ranges from 0 (no damage) to 64 (all individual damage items).
Renal survival	Four years	Renal survival, assessed by the proportion of patients doubling their serum creatinine, reaching Stage V Chronic Kidney Disease (defined as a glomerular filtration rate ≤15 ml/min), or both.
Malignancy	Four years	Proportion of patients with incident malignancies, including type of malignancy
Disease activity	Four years	Disease activity, assessed by the proportion of patients with severe flares
Disease damage assessed by the ANCA-Vasculitis Index of Damage (AVID)	Four years	The AVID has 12 categories and 112 individual damage items. The score ranges from 0 (no damage) to 129 (all individual damage items). Although there are 112 items, 17 items are related to eyes and ears and can be scored for left, right or both.

Trial Locations

Locations (8)

Mayo Clinic Foundation; 🇺🇸 Rochester, Minnesota, United States

Hospital for Special Surgery; 🇺🇸 New York, New York, United States

University Hospital Groningen; 🇳🇱 Groningen, Netherlands

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Boston University; 🇺🇸 Boston, Massachusetts, United States

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States