NCT01738360

Brief Summary

Primary objectives :

  • To investigate the safety and the tolerability of ATO by IV infusions to patients with SLE,
  • To determine the maximum tolerated dose of ATO. Secondary objectives :
  • Evaluation of the clinical and biological response of the SLE to ATO,
  • Time of relapse in case of positive response,
  • Determination of the efficacy,
  • Pharmacokinetic study of ATO.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

2.3 years

First QC Date

November 28, 2012

Last Update Submit

January 5, 2016

Conditions

Systemic Lupus

Keywords

Arsenic trioxideSystemic Lupusclinicallybiologically active

Outcome Measures

Primary Outcomes (1)

  • 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 : * 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.

    30 days after the last infusion

Secondary Outcomes (16)

  • Composite response of SLE

    30 months

  • Anti-nuclear antibodies (ANA).

    30 months

  • Anti-native DNA

    30 months

  • C3 complement

    30 monhs

  • C4 complement

    30 months

  • +11 more secondary outcomes

Study Arms (1)

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).

Drug: Arsenic trioxide

Interventions

Arsenic trioxideDRUG

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 : * Pre-inclusion between D-35 and D-15 * Ten injections during the first month distributed as follows : conventional hospitalization from D1 to D4 (one injection per day) and daily hospitalization day for injections at D8, D11, D15, D18, D22 and D25. * A telephone contact between D32 and D34 * A consultation at D40 then monthly consultation at D60, D90, D120, D150 and D180

Arsenic trioxide

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systemic Lupus meeting the ACR (American College of Rheumatology) criteria, progressive either SLEDAI activity score ≥ 4, despite a corticosteroid therapy ≥ 10 mg / d associated with hydroxychloroquine (in the absence of contraindication or intolerance) and / or an immunosuppressive treatment at a stable dose,
  • Insured,
  • Availability for hospitalization required by the protocol (conventional and daily hospitalizations).

You may not qualify if:

  • Inability to give their signed informed consent form,
  • Performans status \> 2
  • QTcorrected space before treatment \> 0.45 seconds
  • Hemoglobin less than 11g/dL
  • Neutrophils rate below 1 200 / mm3
  • Platelets rate below 100 Giga / mm3
  • Previous history of arrhythmia or heart rhythm disorder or other rhythm trouble by referring cardiologist
  • Heart disorder (progressive pericarditis, valvular disease, ...) according to cardiologist
  • Family previous history of arrhythmias
  • Taking drugs that potentially prolong the QT
  • Hypersensitivity to the active substance of Trisenox® or any of the excipients
  • Serum potassium ≤ 4 milliequivalent / L
  • Magnesemia ≤ 1,8 mg / dl
  • Immunosuppressive treatments, thalidomide introduced within the last 3 months
  • Pregnancy or lactation
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU de Bordeaux

Bordeaux, France

Location

CHRU de Lille

Lille, France

Location

CHU de Marseille

Marseille, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

AP-HP - la Pitié-Salpétrière

Paris, France

Location

CHRU de Strasbourg

Strasbourg, France

Location

Related Publications (1)

  • 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.

    PMID: 33658052DERIVED

MeSH Terms

Interventions

Arsenic Trioxide

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2012

First Posted

November 30, 2012

Study Start

July 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 6, 2016

Record last verified: 2016-01

Locations

FR(6)