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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT01101802
Eligibility Criteria:
Inclusion Criteria:
* Female SLE patients
* Age 18-60 years
* If premenopausal using a reliable method of contraception
* Clinically stable disease
* Taking hydroxychloroquine and up to 15mgs of prednisolone daily
Exclusion Criteria:
* Smokers
* Pregnancy or breast feeding
* Use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted)
* Use of any investigational drug within 1 month prior to screening
* Acute infections 2 weeks prior to Visit 1
* History of ischaemic heart disease or end stage renal disease
* Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01101802
Study Brief:
Protocol Section:
NCT01101802