NCT01586858

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

Geographic Reach
2 countries

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2014

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

April 25, 2012

Last Update Submit

October 25, 2017

Conditions

Granulomatosis With PolyangiitisMicroscopic Polyangiitis

Keywords

VasculitisANCARituximabSmall vessel vasculitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Disease activity

    Four years

  • Disease damage assessed by the increase in Vasculitis Damage Index (VDI)

    Four years

  • Disease damage assessed by the ANCA-Vasculitis Index of Damage (AVID)

    Four years

  • Renal survival

    Four years

  • Malignancy

    Four years

Study Arms (1)

RAVE subjects

Other: Observational

Interventions

ObservationalOTHER

Observational study of subjects previously enrolled in the RAVE trial

RAVE subjects

Eligibility Criteria

Age12 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

RAVE study participants

You may qualify if:

  • Enrollment in the RAVE trial
  • Completion of RAVE Common Closeout Date visit
  • Informed consent

You may not qualify if:

  • Refusal to participate
  • Inability to comply with standard-of-care, including routine clinical visits and testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Boston University

Boston, Massachusetts, 02118, United States

Location

Mayo Clinic Foundation

Rochester, Minnesota, 55905, United States

Location

Hospital for Special Surgery

New York, New York, 10128, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University Hospital Groningen

Groningen, 9713GZ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 20647199BACKGROUND

MeSH Terms

Conditions

Granulomatosis with PolyangiitisMicroscopic PolyangiitisVasculitis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisSystemic VasculitisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Philip Seo, MD

    Johns Hopkins University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2012

First Posted

April 27, 2012

Study Start

May 1, 2012

Primary Completion

May 15, 2014

Study Completion

May 15, 2014

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations

US(7)NL(1)