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:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT02334306
Eligibility Criteria:
Inclusion Criteria:
* Age 18 through 75 years at the time of signing the ICF.
* Fulfill American-European Consensus Group (AECG) criteria for pSS
* ESSDAI score ≥ 6.
* Positive anti-SS-A and/or anti-SS-B autoantibodies and at least IgG \> 13 g/L or RF level \> upper limit of normal (ULN) or positive test for cryoglobulins
* Willingness to undergo protocol-required minor salivary gland biopsies.
* Negative TB test during screening
* Immunization up to date as determined by local standard of care.
Exclusion Criteria:
* Previous treatment with AMG 557/MEDI5872.
* Evidence of signs or symptoms of a viral, bacterial, or fungal infection within 2 weeks (14 days) prior to randomization (Day 1) according to the assessment of the investigator; any infection requiring IV antibiotic or antiviral treatment within 8 weeks of randomization (Day 1); history of herpes zoster within 3 months prior to randomization (Day 1).
* Evidence of significant renal insufficiency
* Positive test at screening for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) antibody.
* Prior administration of any of the following:
1. Belimumab in the past 6 months prior to randomization (Day 1);
2. Rituximab in the past 12 months or CD19+ B cells \< 5/µL if rituximab treatment was more than 12 months prior to randomization (Day 1);
3. Abatacept in the past 6 months prior to randomization (Day 1);
4. Tumor necrosis factor inhibitors (adalimumab, certolizumab, etanercept, golimumab, infliximab) in the past 3 months prior to randomization (Day 1);
5. Tocilizumab in the past 3 months prior to randomization (Day 1);
6. Cyclophosphamide (or any other alkylating agent) in the past 6 months prior to randomization (Day 1); cyclosporine (except for eye drops), tacrolimus, sirolimus, mycophenolate mofetil, azathioprine, or leflunomide in the past 3 months prior to randomization (Day 1).
* Receiving any of the following:
1. Corticosteroids: \> 10 mg/day oral prednisone (or equivalent); Any change or initiation of new dose within 4 weeks prior to signing the ICF through randomization (Day 1); Intramuscular, IV, or intra-articular corticosteroids within 4 weeks prior to signing the ICF through randomization (Day 1); Any change or initiation of new dose of topical corticosteroids within 2 weeks prior to signing the ICF through randomization (Day 1);
2. Antimalarials: any increase or initiation of new dose of antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine) within 12 weeks prior to signing the ICF through randomization (Day 1).
3. Methotrexate: \> 20 mg/week methotrexate; Any change or initiation of new dose of methotrexate within 4 weeks prior to signing the ICF through randomization (Day 1); Any change in route of administration.
4. Any increase or initiation of new dose of regularly scheduled nonsteroidal anti inflammatory drugs (NSAIDs) within 2 weeks prior to signing the ICF through randomization (Day 1).
5. Cevimeline or pilocarpine and cyclosporine eye drops (Restasis): any increase or initiation of new doses within 2 weeks prior to signing the ICF through randomization (Day 1).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02334306
Study Brief:
Protocol Section:
NCT02334306