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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01586858
• Collaborator: University of Alabama at Birmingham (Other), Boston University (Other), Mayo Clinic (Other), Duke University (Other), The Cleveland Clinic (Other), University Medical Center Groningen (Other)
• Enrollment: 67
• Locations: 8
• Actual Duration (Months): 24.4
• Patients Per Site: 8.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Granulomatosis With Polyangiitis; Microscopic Polyangiitis	Other: Observational

Study Design

• Study Type: Observational
• Actual Enrollment: 67 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Rituximab for Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis (RAVE) Long-Term Follow-Up Study
• Actual Study Start Date: May 1, 2012
• Actual Primary Completion Date: May 15, 2014
• Actual Study Completion Date: May 15, 2014

Arms and Interventions

Arm	Intervention/Treatment
RAVE subjects	Other: Observational; Observational study of subjects previously enrolled in the RAVE trial

Outcome Measures

Primary Outcome Measures

1. Long-term safety of rituximab for the treatment of ANCA-associated vasculitis [Four years]

   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

1. Disease activity [Four years]

   Disease activity, assessed by the proportion of patients with severe flares

2. Disease damage assessed by the increase in Vasculitis Damage Index (VDI) [Four years]

   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).

3. Disease damage assessed by the ANCA-Vasculitis Index of Damage (AVID) [Four years]

   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.

4. Renal survival [Four years]

   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.

5. Malignancy [Four years]

   Proportion of patients with incident malignancies, including type of malignancy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	Johns Hopkins University	Baltimore	Maryland	United States	21224
3	Boston University	Boston	Massachusetts	United States	02118
4	Mayo Clinic Foundation	Rochester	Minnesota	United States	55905
5	Hospital for Special Surgery	New York	New York	United States	10128
6	Duke University	Durham	North Carolina	United States	27710
7	The Cleveland Clinic	Cleveland	Ohio	United States	44195
8	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 Center Groningen

Investigators

• Study Director: Philip Seo, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01586858
• Other Study ID Numbers: ML27815
• First Posted: Apr 27, 2012
• Last Update Posted: Oct 27, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Johns Hopkins University: Vasculitis; ANCA; Rituximab; Small vessel vasculitis
• Additional relevant MeSH terms: Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Vasculitis; Systemic Vasculitis

Study Results

No Results Posted as of Oct 27, 2017