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:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-24 @ 5:16 PM
NCT ID:
NCT01689350
Eligibility Criteria:
Inclusion Criteria:
* The American College of Rheumatology established eleven criteria in 1982,which were revised in 1997 as a classificatory instrument to operationalise the definition of SLE in clinical trials.
1. Malar rash (rash on cheeks).
2. Discoid rash (red, scaly patches on skin that cause scarring).
3. Serositis: Pleurisy (inflammation of the membrane around the lungs) or pericarditis (inflammation of the membrane around the heart).
4. Oral ulcers (includes oral or nasopharyngeal ulcers).
5. Arthritis: nonerosive arthritis of two or more peripheral joints, with tenderness, swelling, or effusion.
6. Photosensitivity (exposure to ultraviolet light causes rash, or other symptoms of SLE flareups).
7. Blood-hematologic disorder-hemolytic anemia (low red blood cell count) or leukopenia (white blood cell count\<4000/µl), lymphopenia (\<1500/µl) or thrombocytopenia (\<100000/µl) in the absence of offending drug. Hypocomplementemia is also seen, due to either consumption of C3 and C4 by immune complex-induced inflammation or to congenitally complement deficiency, which may predispose to SLE.
8. Renal disorder: More than 0.5 g per day protein in urine or cellular casts seen in urine under a microscope.
9. Antinuclear antibody test positive.
10. Immunologic disorder: Positive anti-Smith, anti-ds DNA, antiphospholipid antibody, and/or false positive serological test for syphilis. Presence of anti-ss DNA in 70% of cases (though also positive with rheumatic disease and healthy persons).
11. Neurologic disorder: Seizures or psychosis. For the purpose of identifying patients for clinical studies, a person has SLE if any 4 out of 11 symptoms are present simultaneously or serially on two separate occasions. In the meantime, the case has one of the following conditions or more;
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1. HIV (-);
2. Signed the informed consent;
3. Taking contraceptive measures during treatment period.
Exclusion Criteria:
* Poor compliance;
* With lupus mental damage complication, occurrence of epilepsy or unable to express subjective symptoms during the observation period.
* Taking drugs that affect cytochrome P450 2B6, cytochrome P450 3A4 and cytochrome P450 2C19, except corticosteroids.
* Abnormal liver function.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
60 Years
Study:
NCT01689350
Study Brief:
Protocol Section:
NCT01689350