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

Microscopic Polyangiitis Clinical Trial

— RAVELOS  

Official title:

Rituximab for Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis (RAVE) Long-Term Follow-Up Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01586858
• Other study ID #: ML27815
• Status: Terminated
• Phase: N/A
• First received: April 25, 2012
• Last updated: October 25, 2017
• Start date: May 2012
• Est. completion date: May 15, 2014

Study information

• Verified date: October 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: May 15, 2014
• Est. primary completion date: May 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Granulomatosis With Polyangiitis
• Microscopic Polyangiitis
• Systemic Vasculitis
• Vasculitis

Intervention

Other:
• Observational
Observational study of subjects previously enrolled in the RAVE trial

Locations

Country	Name	City	State
Netherlands	University Hospital Groningen	Groningen
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Boston University	Boston	Massachusetts
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Duke University	Durham	North Carolina
United States	Hospital for Special Surgery	New York	New York
United States	Mayo Clinic Foundation	Rochester	Minnesota

Sponsors (7)

Lead Sponsor	Collaborator
Johns Hopkins University	Boston University, Duke University, Mayo Clinic, The Cleveland Clinic, University Medical Center Groningen, University of Alabama at Birmingham

Countries where clinical trial is conducted

United States,  Netherlands, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease activity	Disease activity, assessed by the proportion of patients with severe flares	Four years
Secondary	Disease damage assessed by the increase in Vasculitis Damage Index (VDI)	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).	Four years
Secondary	Disease damage assessed by the ANCA-Vasculitis Index of Damage (AVID)	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.	Four years
Secondary	Renal survival	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.	Four years
Secondary	Malignancy	Proportion of patients with incident malignancies, including type of malignancy	Four years