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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002259-40 | EudraCT Number |
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Difficulty of inclusions and a sufficient number of relevant clinical information
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| Name | Class |
|---|---|
| Medsenic Company | UNKNOWN |
Primary objectives :
Secondary objectives :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arsenic trioxide | Experimental | Thirteen patients will be successively included in this study at 6 different dose levels of arsenic trioxide (0.075, 0.10, 015, 0.20, 0.25 and 0.30 mg / kg / day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arsenic trioxide | Drug | The study duration was 30 months (24 months recruitment + 6 months follow-up).Thirteen patients will be successively included in this study at 6 different dose levels of arsenic trioxide (0.075, 0.10, 015, 0.20, 0.25 and 0.30 mg / kg / day). The treatment should be administered by IV infusion over 2 hours of D1 to D4 (conventional hospitalization) and at D8, D11, D15, D18, D22 and D25. The protocol starts at the dose of 0.10 mg / kg / day. The stage at the dose of 0.075mg/kg/day is planned in case of toxicity with the first stage at the dose of 0.10mg/kg/day. The course of study is as follows :
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac adverse events whatever grade and any adverse event of grade 3 or 4 | The definition of toxicity will be based on "Common Terminology Criteria for Adverse Events, version 4" of the U.S. Department of Health and Human Services, National Institutes of Health / National Cancer Institute. The investigators will consider the occurrence of a significant toxicity if at least one of the following events is observed :
| 30 days after the last infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Composite response of SLE | Combined clinical response using the composite response of SLE or SRI (SLE Responder Index) (SLEDAI + BILAG (British Isles Lupus Assessment Group) + PGA) : a positive response is defined by a reduction of SELENA SLEDAI of at least 4 points, no worsening ( > 0,3 point) of the physician's global assessment (PGA), no new score "A" and no more than one new score "B" about BILAG. This composite index is now the benchmark tool for evaluating therapeutic protocols in SLE. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed HAMIDOU, Profesor | Nantes University Hospital | Principal Investigator |
| Zahir AMOURA, Profesor | AP-HP - La Pitié-Salpétrière | Study Chair |
| Jean SIBILIA, Profesor | CHRU de Strasbourg | Study Chair |
| Jean-François VIALLARD, Profesor | University Hospital, Bordeaux | Study Chair |
| Nicolas SCHLEINITZ, Profesor | CHU de Marseille | Study Chair |
| Eric HACHULLA, Profesor | CHRU de Lille | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | France | ||||
| CHRU de Lille |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33658052 | Derived | Hamidou M, Neel A, Poupon J, Amoura Z, Ebbo M, Sibilia J, Viallard JF, Gaborit B, Volteau C, Hardouin JB, Hachulla E, Rieger F. Safety and efficacy of low-dose intravenous arsenic trioxide in systemic lupus erythematosus: an open-label phase IIa trial (Lupsenic). Arthritis Res Ther. 2021 Mar 3;23(1):70. doi: 10.1186/s13075-021-02454-6. |
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| ID | Term |
|---|---|
| D000077237 | Arsenic Trioxide |
| ID | Term |
|---|---|
| D001152 | Arsenicals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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|
| 30 months |
| Anti-nuclear antibodies (ANA). | The modification of anti-nuclear antibodies (ANA). | 30 months |
| Anti-native DNA | The modification of anti-native DNA. | 30 months |
| C3 complement | The modification of C3 complement. | 30 monhs |
| C4 complement | The modification of C4 complement. | 30 months |
| Sedimentation rate | Analysis of Sedimentation rate. | 30 months |
| Serum creatinine | Analysis of serum creatinine. | 30 months |
| Proteinuria/creatinuria ratio | Analysis of proteinuria/creatinuria ratio. | 30 months |
| Serum protein electrophoresis | Analysis of serum protein electrophoresis. | 30 months |
| Quantitation of immunoglobulins | Analysis of quantitation of immunoglobulins. | 30 months |
| Quality of life | Assessment of quality of life wih questionnaires SF36 and LupusQol. | 30 months |
| Steroids | Reduction of the dose of steroids throughout the study. | 30 months |
| Immunosuppressive treatments | Cessation of immunosuppressive treatments. | 30 months |
| Response time | Response time in case of positive response. | 30 months |
| Time to relapse | Time to relapse in case of positive response. | 30 months |
| Blood test of arsenic | Pharmacokinetic study of arsenic plasma with analysis of potential correlations blood rates/ toxicity and response. | D1, D2, D3, D4, D8, D11, D15, D18, D22 and D25 (before and after each infusion) |
| Lille |
| France |
| CHU de Marseille | Marseille | France |
| Nantes University Hospital | Nantes | 44093 | France |
| AP-HP - la Pitié-Salpétrière | Paris | France |
| CHRU de Strasbourg | Strasbourg | France |