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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 January 2016 |
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Main ID: |
NCT01738360 |
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Date of registration:
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28/11/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC)
LUPSENIC |
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Scientific title:
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Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) |
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Date of first enrolment:
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July 2013 |
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Target sample size:
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11 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01738360 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Eric HACHULLA, Profesor |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHRU de Lille |
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Name:
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Nicolas SCHLEINITZ, Profesor |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU de Marseille |
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Name:
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Jean-François VIALLARD, Profesor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Bordeaux |
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Name:
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Jean SIBILIA, Profesor |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHRU de Strasbourg |
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Name:
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Mohamed HAMIDOU, Profesor |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU de Nantes |
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Name:
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Zahir AMOURA, Profesor |
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Address:
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Telephone:
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Email:
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Affiliation:
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AP-HP - La Pitié-Salpétrière |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Lupus
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Intervention(s)
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Drug: Arsenic trioxide
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Primary Outcome(s)
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Cardiac adverse events whatever grade and any adverse event of grade 3 or 4
[Time Frame: 30 days after the last infusion]
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Secondary Outcome(s)
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Anti-native DNA
[Time Frame: 30 months]
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Anti-nuclear antibodies (ANA).
[Time Frame: 30 months]
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Blood test of arsenic
[Time Frame: D1, D2, D3, D4, D8, D11, D15, D18, D22 and D25 (before and after each infusion)]
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Proteinuria/creatinuria ratio
[Time Frame: 30 months]
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Quantitation of immunoglobulins
[Time Frame: 30 months]
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Response time
[Time Frame: 30 months]
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C3 complement
[Time Frame: 30 monhs]
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Composite response of SLE
[Time Frame: 30 months]
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Quality of life
[Time Frame: 30 months]
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Sedimentation rate
[Time Frame: 30 months]
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Steroids
[Time Frame: 30 months]
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C4 complement
[Time Frame: 30 months]
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Immunosuppressive treatments
[Time Frame: 30 months]
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Time to relapse
[Time Frame: 30 months]
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Serum creatinine
[Time Frame: 30 months]
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Serum protein electrophoresis
[Time Frame: 30 months]
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Secondary ID(s)
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2012-002259-40
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RC12_0021
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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