Trial · NCT01738360
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cardiac adverse events whatever grade and any adverse event of grade 3 or 4 | 30 days after the last infusion | 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 : * Any symptomatic toxicity (and / or abnormality) cardiac and / or QTc prolongation \> 480 msec., * Apart from cardiac toxicity, toxicity of any grade 3 or 4 and irreversible toxicity (within 30 days) of any grade 1 or 2. |
| Secondary | Composite response of SLE | 30 months | 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. |
| Secondary | Anti-nuclear antibodies (ANA). | 30 months | The modification of anti-nuclear antibodies (ANA). |
| Secondary | Anti-native DNA | 30 months | The modification of anti-native DNA. |
| Secondary | C3 complement | 30 monhs | The modification of C3 complement. |
| Secondary | C4 complement | 30 months | The modification of C4 complement. |
| Secondary | Sedimentation rate | 30 months | Analysis of Sedimentation rate. |
| Secondary | Serum creatinine | 30 months | Analysis of serum creatinine. |
| Secondary | Proteinuria/creatinuria ratio | 30 months | Analysis of proteinuria/creatinuria ratio. |
| Secondary | Serum protein electrophoresis | 30 months | Analysis of serum protein electrophoresis. |
| Secondary | Quantitation of immunoglobulins | 30 months | Analysis of quantitation of immunoglobulins. |
| Secondary | Quality of life | 30 months | Assessment of quality of life wih questionnaires SF36 and LupusQol. |
| Secondary | Steroids | 30 months | Reduction of the dose of steroids throughout the study. |
| Secondary | Immunosuppressive treatments | 30 months | Cessation of immunosuppressive treatments. |
| Secondary | Response time | 30 months | Response time in case of positive response. |
| Secondary | Time to relapse | 30 months | Time to relapse in case of positive response. |
| Secondary | Blood test of arsenic | D1, D2, D3, D4, D8, D11, D15, D18, D22 and D25 (before and after each infusion) | Pharmacokinetic study of arsenic plasma with analysis of potential correlations blood rates/ toxicity and response. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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