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 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT01160666
Eligibility Criteria:
Inclusion Criteria:
* Have a diagnosis of primary SS according to the updated American European Consensus Group Criteria. In addition, patients must be always positive for anti-SSA or anti-SSB antibodies
* Have the presence, at screening, of Systemic involvement (polysynovitis, skin, renal, lung, CNS involvement, peripheral neuropathy, vasculitis, autoimmune cytopenia, defined in Annex 1) or persistent (up to 2 months) parotid, submandibular or lachrymal gland swelling of more than 2 cm OR
Objective sicca (positive oral and/or ocular tests reported in the American European Consensus Group Criteria) with at least one among the following biological features of serum B lymphocyte activation :
increased IgG levels increased free light chain levels of immunoglobulins (according to central laboratory ranges) increased serum beta2-microglobulin levels decreased C4 levels (C4 levels inferior to central laboratory ranges) monoclonal gammapathy cryoglobulinemia OR
* SS of more recent onset, i.e., less than 5 years of duration of symptoms, associated with:
* oral or ocular dryness
* fatigue
* musculoskeletal pain (i.e, 3 criteria for response as reported at page (ix-x), characterized by VAS score more than 50/100 in all the 3 fields.
Exclusion Criteria:
1. Any BLyS-targeted (BLyS-receptor fusion protein \[BR3\], TACI Fc, or belimumab) at any time.
2. Any of the following within 364 days of Day 0:
* B-cell targeted therapy (eg, rituximab, other anti-CD20 agents, anti-CD22 \[epratuzumab\], anti-CD52 \[alemtuzumab\]
* A biologic investigational agent other than B cell targeted therapy (eg, abetimus sodium, anti CD40L antibody \[BG9588/ IDEC 131\]).
4- Intravenous or oral cyclophosphamide within 180 days of Day 0.
5- Any of the following within 90 days of Day 0:
* Anti-TNF therapy
* Interleukin-1 receptor antagonist
* Abatacept
* Interleukin-6 receptor antagonist
* Intravenous immunoglobulin
* Prednisone \> 100 mg/day
* Plasmapheresis.
9- Very severe SS disease.
10- Major organ or hematopoietic stem cell/marrow transplant.
11- Unstable or uncontrolled acute or chronic diseases not due to SS
13- History of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
14- Required management of acute or chronic infections, as follows:
* Currently on any suppressive therapy for a chronic infection
* Hospitalization for treatment of infection within 60 days of Day 0.
* Use of parenteral (IV or IM) antibiotics
16- Historically or at screening positive test for HIV antibody, hepatitis C virus antibodies, or, hepatitis B surface antigen (HbsAg) (with or without positive serum HBV DNA), or antiHBcAg positivity (without anti-HbsAg positivity).
17- Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed:
* Stable Grade 3 prothrombin time (PT) secondary to warfarin treatment.
* Stable Grade 3/4 proteinuria (≤ 6 g/24 hour equivalent by spot urine protein to creatinine ratio allowed). (mentioned earlier in Exclusion #8)
* Stable Grade 3 neutropenia or stable Grade 3 white blood cell count.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01160666
Study Brief:
Protocol Section:
NCT01160666