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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Alabama at Birmingham
Boston University
Mayo Clinic
Duke University
The Cleveland Clinic
University Medical Centre Groningen
Information provided by (Responsible Party):
Philip Seo, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01586858
First received: April 25, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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 Intervention
Granulomatosis With Polyangiitis
Microscopic Polyangiitis
Other: Observational

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Long-term safety of rituximab for the treatment of ANCA-associated vasculitis [ Time Frame: Four years ] [ Designated as safety issue: Yes ]
    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:
  • Disease activity [ Time Frame: Four years ] [ Designated as safety issue: No ]
    Disease activity, assessed by the proportion of patients with severe flares

  • Disease damage [ Time Frame: Four years ] [ Designated as safety issue: No ]
    Disease damage, assessed by the increase in VDI and AVID scores from baseline

  • Renal survival [ Time Frame: Four years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Four years ] [ Designated as safety issue: No ]
    Proporition of patients with incident malignancies, including type of malignancy


Estimated Enrollment: 180
Study Start Date: May 2012
Groups/Cohorts Assigned Interventions
RAVE subjects Other: Observational
Observational study of subjects previously enrolled in the RAVE trial

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Centre Groningen
  More Information

Publications:
Responsible Party: Philip Seo, Director, the Johns Hopkins Vasculitis Center, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01586858     History of Changes
Other Study ID Numbers: ML27815
Study First Received: April 25, 2012
Last Updated: April 25, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014