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Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC) (LUPSENIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01738360
Recruitment Status : Terminated (Difficulty of inclusions and a sufficient number of relevant clinical information)
First Posted : November 30, 2012
Last Update Posted : January 6, 2016
Medsenic Company
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Drug: Arsenic trioxide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE)
Study Start Date : July 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arsenic Lupus

Arm Intervention/treatment
Experimental: Arsenic trioxide
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

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

Primary Outcome Measures :
  1. Cardiac adverse events whatever grade and any adverse event of grade 3 or 4 [ Time Frame: 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 Outcome Measures :
  1. Composite response of SLE [ Time Frame: 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.

  2. Anti-nuclear antibodies (ANA). [ Time Frame: 30 months ]
    The modification of anti-nuclear antibodies (ANA).

  3. Anti-native DNA [ Time Frame: 30 months ]
    The modification of anti-native DNA.

  4. C3 complement [ Time Frame: 30 monhs ]
    The modification of C3 complement.

  5. C4 complement [ Time Frame: 30 months ]
    The modification of C4 complement.

  6. Sedimentation rate [ Time Frame: 30 months ]
    Analysis of Sedimentation rate.

  7. Serum creatinine [ Time Frame: 30 months ]
    Analysis of serum creatinine.

  8. Proteinuria/creatinuria ratio [ Time Frame: 30 months ]
    Analysis of proteinuria/creatinuria ratio.

  9. Serum protein electrophoresis [ Time Frame: 30 months ]
    Analysis of serum protein electrophoresis.

  10. Quantitation of immunoglobulins [ Time Frame: 30 months ]
    Analysis of quantitation of immunoglobulins.

  11. Quality of life [ Time Frame: 30 months ]
    Assessment of quality of life wih questionnaires SF36 and LupusQol.

  12. Steroids [ Time Frame: 30 months ]
    Reduction of the dose of steroids throughout the study.

  13. Immunosuppressive treatments [ Time Frame: 30 months ]
    Cessation of immunosuppressive treatments.

  14. Response time [ Time Frame: 30 months ]
    Response time in case of positive response.

  15. Time to relapse [ Time Frame: 30 months ]
    Time to relapse in case of positive response.

  16. Blood test of arsenic [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  • Increase corticosteroids beyond 20 mg / day within 15 days before inclusion
  • Immunosuppressive treatments, thalidomide introduced within the last 3 months
  • Biotherapy (rituximab, belimumab, ...) introduced within 6 months prior to inclusion
  • Pregnancy or lactation
  • For women of childbearing age, men and their partner : unless effective contraception for the duration of participation in the study that is 7 months
  • Creatinine clearance <50 ml / min,
  • Hepatocellular insufficiency (TP <50%), and / or AST (aspartate aminotransferase) / ALT (alanine aminotransferase) / ALP (alkaline phosphatase) > 2N
  • HBsAg positive, DNA detectable HbS
  • Infection with HIV, HBV (hepatitis B virus) or HCV (hepatitis C virus)
  • Renal or progressive central neurological impairment with possible alternative therapeutic (to be discussed with the principal investigator and scientific board meeting)
  • Peripheral neuropathy
  • Unweaned alcoholism
  • Minor
  • Patients older than 65 years
  • Patient having been professionally exposed to arsenic (cleaning electronic circuits for example)
  • Guardianship patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01738360

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CHU de Bordeaux
Bordeaux, France
CHRU de Lille
Lille, France
CHU de Marseille
Marseille, France
Nantes University Hospital
Nantes, France, 44093
AP-HP - la Pitié-Salpétrière
Paris, France
CHRU de Strasbourg
Strasbourg, France
Sponsors and Collaborators
Nantes University Hospital
Medsenic Company
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Principal Investigator: Mohamed HAMIDOU, Profesor CHU de Nantes
Study Chair: 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

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Responsible Party: Nantes University Hospital Identifier: NCT01738360    
Other Study ID Numbers: RC12_0021
2012-002259-40 ( EudraCT Number )
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016
Keywords provided by Nantes University Hospital:
Arsenic trioxide
Systemic Lupus
biologically active
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arsenic Trioxide
Antineoplastic Agents