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

NCT ID: NCT01586858

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-05-15

Brief Summary

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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

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Conditions

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Granulomatosis With Polyangiitis Microscopic Polyangiitis

Keywords

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Vasculitis ANCA Rituximab Small vessel vasculitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RAVE subjects

Observational

Intervention Type OTHER

Observational study of subjects previously enrolled in the RAVE trial

Interventions

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Observational

Observational study of subjects previously enrolled in the RAVE trial

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Seo, MD

Role: STUDY_DIRECTOR

Johns Hopkins University

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Boston University

Boston, Massachusetts, United States

Site Status

Mayo Clinic Foundation

Rochester, Minnesota, United States

Site Status

Hospital for Special Surgery

New York, New York, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

The Cleveland Clinic

Cleveland, Ohio, United States

Site Status

University Hospital Groningen

Groningen, , Netherlands

Site Status

Countries

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United States Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 20647199 (View on PubMed)

Other Identifiers

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ML27815

Identifier Type: -

Identifier Source: org_study_id