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

Johns Hopkins University

Status: Terminated

Conditions: Granulomatosis With Polyangiitis; Microscopic Polyangiitis

Treatments: Other: Observational

Study type: Observational

Funder types: Other

Identifiers

NCT01586858

ML27815

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 12 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

67 participants in 1 patient group

RAVE subjects

Treatment:

Other: Observational