Brief Title
Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study
Official Title
Rituximab for Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis (RAVE) Long-Term Follow-Up Study
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.
Study Type
Observational
Primary Outcome
Long-term safety of rituximab for the treatment of ANCA-associated vasculitis
Secondary Outcome
Disease activity
Condition
Granulomatosis With Polyangiitis
Intervention
Observational
Study Arms / Comparison Groups
RAVE subjects
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
67
Start Date
May 2012
Completion Date
May 15, 2014
Primary Completion Date
May 15, 2014
Eligibility 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.
Gender
All
Ages
12 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
Philip Seo, MD, ,
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT01586858
Organization ID
ML27815
Responsible Party
Sponsor
Study Sponsor
Johns Hopkins University
Collaborators
University of Alabama at Birmingham
Study Sponsor
Philip Seo, MD, Study Director, Johns Hopkins University
Verification Date
October 2017