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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT02270957
Eligibility Criteria:
Inclusion Criteria:
1. Signed Written Informed Consent
2. Four 1997 revised ACR Classification Criteria for SLE
3. Active polyarticular arthritis meeting at minimum BILAG 2004 B definition with a minimum of 3 tender and 3 swollen joints observed at the screening visit
4. Men and women 18 to 70 years of age.
5. Women of childbearing potential and men with partners of childbearing potential must use an acceptable method of birth control throughout the study
6. Women of childbearing potential must have a negative urine pregnancy test at screening and Study Day 1 (baseline visit) and may not be breast feeding
Exclusion Criteria:
1. Current severe, organ-threatening disease (e.g. acute nephritis appropriate for induction therapy, CNS lupus (excepting chorea, cranial neuropathy, and resolving optic neuritis) or any lupus condition requiring cyclophosphamide, biologic therapy, or IV bolus steroids of \>/= 500 mg.
2. Subjects who are incapable of understanding or completing study-related assessments.
3. Subjects with any condition, whether or not related to SLE, which, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
4. Subjects with a history of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ.
5. Subjects who currently abuse drugs or alcohol.
6. Subjects with acute herpes zoster or cytomegalovirus (CMV) within 2 months of screening.
7. Subjects who have received any live vaccines within 3 months of first dose.
8. Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection (eg, chronic pyelonephritis, osteomyelitis, or bronchiectasis).
9. Subjects at risk for tuberculosis (TB).
10. Subjects known to be positive for hepatitis B surface antigen or hepatitis C unless negative by PCR or RIBA
11. Acute hemolytic anemia with hemoglobin \< 7.0 g/dL or known change in Hg by 2.0 g/dL within four months
12. WBC \< 2500/mm3 (\< 3 x 109/L) unless due to chronic stable lupus activity
13. Platelets \< 40,000/mm3 (\< 3 x 109/L) (If less than 100,000 must have been stable (within a range of 10,000/mm3 ) within two months of screening or in two tests during the screening period.
14. Serum creatinine \> 2 times the ULN
15. Serum ALT or AST \> 2.5 times the ULN
16. Any other laboratory test results that, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
17. Known allergy/sensitivity to the study agent or carrier.
18. Treatment with investigational drug within 28 days (or 5 terminal half-lives) of the Day 1 dose.
19. Cyclophosphamide within 3 months of Day 1 or bolus IV steroids \>/=500 mg within 1 month
20. Prednisone \> 20 mg qd after the screening visit
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02270957
Study Brief:
Protocol Section:
NCT02270957