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

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ClinicalTrials.gov Identifier: NCT01586858
Recruitment Status : Terminated (Loss of Funding)
First Posted : April 27, 2012
Last Update Posted : October 27, 2017
Sponsor:
Collaborators:
University of Alabama at Birmingham
Boston University
Mayo Clinic
Duke University
The Cleveland Clinic
University Medical Center Groningen
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Granulomatosis With Polyangiitis Microscopic Polyangiitis Other: Observational

Study Type : Observational
Actual Enrollment : 67 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rituximab for Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis (RAVE) Long-Term Follow-Up Study
Actual Study Start Date : May 2012
Actual Primary Completion Date : May 15, 2014
Actual Study Completion Date : May 15, 2014


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



Primary Outcome Measures :
  1. Long-term safety of rituximab for the treatment of ANCA-associated vasculitis [ Time Frame: 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 :
  1. Disease activity [ Time Frame: Four years ]
    Disease activity, assessed by the proportion of patients with severe flares

  2. Disease damage assessed by the increase in Vasculitis Damage Index (VDI) [ Time Frame: 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).

  3. Disease damage assessed by the ANCA-Vasculitis Index of Damage (AVID) [ Time Frame: 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.

  4. Renal survival [ Time Frame: 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.

  5. Malignancy [ Time Frame: Four years ]
    Proportion of patients with incident malignancies, including type of malignancy



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Ages Eligible for Study:   12 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
RAVE study participants
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586858


Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02118
United States, Minnesota
Mayo Clinic Foundation
Rochester, Minnesota, United States, 55905
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10128
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Netherlands
University Hospital Groningen
Groningen, Netherlands, 9713GZ
Sponsors and Collaborators
Johns Hopkins University
University of Alabama at Birmingham
Boston University
Mayo Clinic
Duke University
The Cleveland Clinic
University Medical Center Groningen
Investigators
Study Director: Philip Seo, MD Johns Hopkins University

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01586858     History of Changes
Other Study ID Numbers: ML27815
First Posted: April 27, 2012    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by Johns Hopkins University:
Vasculitis
ANCA
Rituximab
Small vessel vasculitis

Additional relevant MeSH terms:
Vasculitis
Systemic Vasculitis
Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Rituximab
Antibodies, Antineutrophil Cytoplasmic
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents