Clinical trial NCT01586858: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Granulomatosis With Polyangiitis
Microscopic Polyangiitis
Keywords: Vasculitis
ANCA
Rituximab
Small vessel vasculitis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Boston University
name: Mayo Clinic
name: Duke University
name: The Cleveland Clinic
name: University Medical Center Groningen
First posted: 2012-04-27
Enrollment: 67
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RAVE study participants

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.


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.

Primary outcomes:
measure: Long-term safety of rituximab for the treatment of ANCA-associated vasculitis
timeFrame: Four years
Secondary outcomes:
measure: Disease activity
timeFrame: Four years
measure: Disease damage assessed by the increase in Vasculitis Damage Index (VDI)
timeFrame: Four years
measure: Disease damage assessed by the ANCA-Vasculitis Index of Damage (AVID)
timeFrame: Four years
measure: Renal survival
timeFrame: Four years
measure: Malignancy
timeFrame: Four years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Foundation
state: Minnesota
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Groningen
country: Netherlands
facility: University Hospital Groningen
Study officials:
affiliation: Johns Hopkins University
name: Philip Seo, MD
role: STUDY_DIRECTOR
References:
citation: 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.