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

Rituximab for Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis (RAVE) Long-Term Follow-Up Study

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.

Study Overview

• Status: Terminated
• Conditions: Microscopic Polyangiitis; Granulomatosis With Polyangiitis
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713GZ
    • University Hospital Groningen
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University Of Alabama
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Foundation
  • New York
    • New York, New York, United States, 10128
      • Hospital for Special Surgery
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

RAVE study participants

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RAVE subjects	Other: Observational; Observational study of subjects previously enrolled in the RAVE trial

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease activity	Disease activity, assessed by the proportion of patients with severe flares	Four years
Disease damage assessed by the increase in Vasculitis Damage Index (VDI)	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).	Four years
Disease damage assessed by the ANCA-Vasculitis Index of Damage (AVID)	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.	Four years
Renal survival	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.	Four years
Malignancy	Proportion of patients with incident malignancies, including type of malignancy	Four years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Boston University; Mayo Clinic; University of Alabama at Birmingham; University Medical Center Groningen; The Cleveland Clinic; Duke University
• Investigators: Study Director: Philip Seo, MD, Johns Hopkins University

Publications and helpful links

General Publications

• Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert-Margolis V, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U; RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010 Jul 15;363(3):221-32. doi: 10.1056/NEJMoa0909905.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2012
• Primary Completion (ACTUAL): May 15, 2014
• Study Completion (ACTUAL): May 15, 2014

Study Registration Dates

• First Submitted: April 25, 2012
• First Submitted That Met QC Criteria: April 25, 2012
• First Posted (ESTIMATE): April 27, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Rituximab; Vasculitis; ANCA; Small vessel vasculitis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Lung Diseases; Lung Diseases, Interstitial; Cerebral Small Vessel Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Vasculitis; Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Systemic Vasculitis
• Other Study ID Numbers: ML27815