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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001807-29 | EudraCT Number |
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failure of recruit
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| Name | Class |
|---|---|
| Theradiag | OTHER |
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The aim of the investigators' study is to evaluate whether monitoring serum rituximab levels could be an interesting tool in the follow-up of ANCA-associated vasculitis patients.
All consecutive patients, hospitalized for a new diagnosis of ANCA-associated vasculitis or the relapse of a known ANCA-associated vasculitis, in which the decision to start an induction regimen with rituximab has been taken, will be included.
Serum rituximab levels (along with serum anti-rituximab antibodies levels) will be determined (at M+1 and M+3) and the correlation with clinical outcome at M+6 will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | a classical induction regimen with rituximab (decision taken before inclusion), implying an infusion of 375mg/m² per week, for 4 consecutive weeks (from week -3 until week 0) with blood specimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood specimen | Other | blood specimen for serum rituximab level and serum anti-rituximab level at M1 and M3 after stop of induction rituximab treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum rituximab levels | rituximab level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0, 6 months after stop of induction regimen | 1 month after stop of rituximab induction regimen |
| Measure | Description | Time Frame |
|---|---|---|
| serum rituximab levels | rituximab level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen | 3 months after stop of rituximab induction regimen |
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Inclusion Criteria:
Exclusion Criteria:
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Granulomatosis with polyangiitis or microscopic polyangiitis (according to Chapel Hill criterions), with or without detectable ANCA
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| Name | Affiliation | Role |
|---|---|---|
| Pascal CATHEBRAS, PHD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HĂ´pital Edouard Herriot | Lyon | 69003 | France | |||
| HĂ´pital de la Croix Rousse |
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| ID | Term |
|---|---|
| D014890 | Granulomatosis with Polyangiitis |
| D055953 | Microscopic Polyangiitis |
| 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 |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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blood specimen for serum rituximab level and serum anti-rituximab level
| serum rituximab levels |
rituximab level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen |
| 6 months after stop of rituximab induction regimen |
| serum anti-rituximab antibodies | serum anti-rituximab antibodies level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen | 1 month after stop of rituximab induction regimen |
| serum anti-rituximab antibodies | serum anti-rituximab antibodies level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen | 3 months after stop of rituximab induction regimen |
| serum anti-rituximab antibodies | serum anti-rituximab antibodies level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen | 6 months after stop of rituximab induction regimen |
| Serum B lymphocytes (CD19+ cells) levels | Serum B lymphocytes (CD19+ cells) levels comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen | 1 month after stop of rituximab induction regimen |
| Serum B lymphocytes (CD19+ cells) levels | Serum B lymphocytes (CD19+ cells) levels comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen | 3 months after stop of rituximab induction regimen |
| Serum B lymphocytes (CD19+ cells) levels | Serum B lymphocytes (CD19+ cells) levels comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen | 6 months after stop of rituximab induction regimen |
| patient number with adverse event | frequency and nature of rituximab-attributed adverse events | from start of induction rituximab regimen until six monthes after stop of induction regimen |
| Lyon |
| 69317 |
| France |
| CH Lyon Sud | Pierre-Bénite | 69495 | France |
| CHU Saint-Etienne | Saint-Etienne | 42055 | France |
| D056647 | Systemic Vasculitis |
| D014657 | 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 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |