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 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT05623592
Eligibility Criteria:
Inclusion Criteria:
* Subjects male or female, aged ≥18 years
* Written informed consent of the capable subject for voluntary participation in the study.
* Diagnosis of GCA as confirmed by the investigator fulfilment (also in retrospect) of the proposed extended 1990 classification criteria for GCA .
* Previous treatment with glucocorticoids and tocilizumab for new or relapsing GCA
* GCA patients who have been treated with tocilizumab and in whom discontinuation of tocilizumab therapy has been decided by the treating rheumatologist, within standard treatment at the department of rheumatology are eligible.
* total tocilizumab therapy should have been at least 6 months before inclusion.
* Patients should be in stable remission (defined as the absence of signs or symptoms of GCA and normal C-Reactive Protein (\<1mg/dl), off glucocorticoids for at least 1 months at screening.
* Willing and able to inject methotrexate or placebo subcutaneously at randomization
* Male and female subjects agreeing to conduct efficient contraception (unless they have no childbearing potential)
Exclusion Criteria:
* Severe renal (glomerular filtration rate \<30/min) failure
* Conditions other than GCA requiring continuous or intermittent treatment with oral or parenteral Glucocorticoids unless the last exposure to Glucocorticoids was \>1 months before screening
* Other inflammatory rheumatic diseases (e.g. rheumatoid arthritis)
* Current treatment with any other conventional, biologic or targeted synthetic DMARD except tocilizumab
* Elevation of transaminases above three times the norm
* Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investigational product, up to 30 days prior to participation in this clinical trial.
* Pregnant or breast feeding women
* Contraindications for therapy with Methotrexate, as indicated in the summary of product characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05623592
Study Brief:
Protocol Section:
NCT05623592