Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT01738360
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01738360
Study Brief:
Protocol Section:
NCT01738360