An observational study in Granulomatosis With Polyangiitis and Microscopic Polyangiitis, sponsored by Johns Hopkins University. Terminated at 8 sites in 2 countries. Open to participants aged 12 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-10-27.
Sponsored by Johns Hopkins University · Observational
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.
104 studies on the registry are indexed under Granulomatosis with Polyangiitis; 16 are open to participants now.
This study's enrollment of 67 is below the median of 100 across 32 observational studies indexed under Granulomatosis with Polyangiitis.
Browse Granulomatosis with Polyangiitis studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
RAVE study participants
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Observational
Observational study of subjects previously enrolled in the RAVE trial
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).
Time frame: Four years
Disease activity
Disease activity, assessed by the proportion of patients with severe flares
Time frame: Four years
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).
Time frame: Four years
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.
Time frame: Four years
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.
Time frame: Four years
Malignancy
Proportion of patients with incident malignancies, including type of malignancy
Time frame: Four years
This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Granulomatosis with Polyangiitis →