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

Study Overview
=================
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.

Official Title
-----------------
Rituximab for Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis (RAVE) Long-Term Follow-Up Study

Conditions
-----------------
Microscopic Polyangiitis, Granulomatosis With Polyangiitis

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment in the RAVE trial Completion of RAVE Common Closeout Date visit Informed consent Exclusion Criteria: Refusal to participate Inability to comply with standard-of-care, including routine clinical visits and testing.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RAVE subjects<br> | Other: Observational<br>* Observational study of subjects previously enrolled in the RAVE trial<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vasculitis, ANCA, Rituximab, Small vessel vasculitis