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 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT02477150
Eligibility Criteria:
Inclusion Criteria:
1. SLE patients who fulfill ≥4 of the 1997 ACR (17) or the 2012 SLICC/ACR criteria for SLE (18)
2. Age ≥18 years
3. Clinically inactive disease with SELENA-SLEDAI score \<6 (see below) and receiving stable dose of immunosuppressive agents for ≥6 months
4. History of varicella (chickenpox) or herpes zoster infection in the past
5. Willing to comply with all study procedures
Exclusion Criteria:
1. Active infection, including upper respiratory tract infection
2. Active untreated tuberculosis
3. Human immunodeficiency virus (HIV) infection
4. Lymphocyte count \<500/mm2
5. Reduced serum IgG, IgA or IgM level (below normal range)
6. Serum creatinine \>200umol/L
7. History of hematological malignancies (eg. lymphoma, leukaemia) and other solid tumors
8. Patients receiving doses of immunosuppressive agents exceeding the following:
* Prednisolone (\>15mg) or equivalent
* Azathioprine (\>100mg/day)
* Mycophenolate mofetil (\>1000mg/day)
* Cyclosporin A (\>100mg/day)
* Tacrolimus (\>3mg/day)
* Methotrextate (\>15mg/week)
* Cyclophosphamide (any dose)
* Biological agents eg. rituximab, belimumab (any dose)
9. Patients who are pregnant or plan to become pregnancy within one year of study entry
10. Patients who cannot give a written consent (mentally incapable or illiterate)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02477150
Study Brief:
Protocol Section:
NCT02477150