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:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT02101333
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of TA : ACR and /or Ishikawa modified Sharma criteria of TA
* Age of 18 years or older
* Willing to use an effective means of birth control throughout the study
Exclusion Criteria:
* Patients immunosuppressive treatment or biologics other than steroids 4 months before
* Evidence of active infection (including chronic infection)
* HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen
* History of any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin or solid tumors treated with curative therapy and disease-free for at least 5 years
* Inability to provide informed consent
* Cytopenia, as defined by platelet count \< 100 × 109/L (100,000/mm3), hemoglobin \< 85 g/L (8.5 g/dL; 5.3 mmol/L), absolute neutrophil count \< 2.0 × 109/L (2000/mm3), absolute lymphocyte count \< 0.5 × 109/L (500/mm3)
* Insufficient liver function
* Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or creatinine clearance of 20 ml/min or less
* Positive tuberculin skin test and/or positive Quantiferon
* Radiographic evidence suggestive of tuberculosis
* Contraindication to and precaution in use of Tocilizumab according to the summary product description
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
77 Years
Study:
NCT02101333
Study Brief:
Protocol Section:
NCT02101333