Trial · NCT01738360
Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC)
NCT01738360, Phase 2, Terminated, Nantes University Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC). Trials, record NCT01738360. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01738360
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC)
- NCT number
- NCT01738360
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Nantes University Hospital
- Conditions
- Systemic Lupus
- Interventions
- Arsenic trioxide
- First posted
- 2012-11-30
- Last updated
- 2016-01-06
- Other registries' IDs
- eudract:2012-002259-40
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33658052 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01738360
GET https://conductscience.org/api/trials/v1/NCT01738360/registered