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Loss of Funding
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| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
| Boston University | OTHER |
| Mayo Clinic | OTHER |
| Duke University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAVE subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | Observational study of subjects previously enrolled in the RAVE trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease activity | Disease activity, assessed by the proportion of patients with severe flares | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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RAVE study participants
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| Name | Affiliation | Role |
|---|---|---|
| Philip Seo, MD | Johns Hopkins University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Johns Hopkins University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20647199 | Background | 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. |
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| ID | Term |
|---|---|
| D014890 | Granulomatosis with Polyangiitis |
| D055953 | Microscopic Polyangiitis |
| D014657 | Vasculitis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| OTHER |
| The Cleveland Clinic | OTHER |
| University Medical Center Groningen | OTHER |
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| 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. | 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. | Four years |
| Malignancy | Proportion of patients with incident malignancies, including type of malignancy | Four years |
| Baltimore |
| Maryland |
| 21224 |
| United States |
| Boston University | Boston | Massachusetts | 02118 | United States |
| Mayo Clinic Foundation | Rochester | Minnesota | 55905 | United States |
| Hospital for Special Surgery | New York | New York | 10128 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University Hospital Groningen | Groningen | 9713GZ | Netherlands |
| D056647 | Systemic Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D059345 | Cerebral Small Vessel Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |