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 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT00363350
Eligibility Criteria:
Inclusion Criteria:
* Stimulated whole saliva secretion ≥ 0,15 ml/min
* Male or female \> 18 years
* Primary SS according to the revised European - U.S. criteria(22)
* Positive autoantibodies (IgM-Rf \> 10 and SS-A and/or SS-B)
* Parotid gland biopsy (paraffine material and fresh frozen tissue) with characteristic features of SS performed at time of inclusion (no longer than 12 months ago)
* Use of reliable method of contraception during the study
* Written informed consent
Exclusion Criteria:
* The presence of any other connective tissue disease
* Preceding treatment with anti-TNF or other monoclonal antibodies
* Use of prednisone, hydroxychloroquine less than 1 month ago
* Use of MTX, cyclophosphamide, cyclosporin, azathioprine and other DMARDS less than 0,5 year ago
* Serum creatine \> 2.8 mg/dl (250 micromol/l)
* ASAT or ALAT outside 1.5 x upper normal range of the laboratory
* Hb \< 9 g/dl (5.6 mmol/l) for males and 8.5 g/dl (5.3 mmol/l) for females
* Neutrophil granulocytes less than 0.5 x 109/l
* Platelet count less then 50 x 109/l
* Positive pregnancy test or breast-feeding
* History of alcohol or drug abuse
* Serious infections
* Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which places the patient at an unacceptable risk for participation in the study
* History of any malignancy with the exception of completely resected basal cell carcinoma of the skin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00363350
Study Brief:
Protocol Section:
NCT00363350