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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT05199103
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of Graves' disease associated with active thyroid eye disease and a clinical activity score of ≥ 3
* Euthyroid or with mild hypo- or hyperthyroidism defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50% above or below the normal limits
* previous ineffective treatment (partial response, recurrence or progression of symptoms) with moderate-to-high doses of glucocorticoids (at least 4.5 g of methylprednisolone)
Exclusion Criteria:
* hypersensitivity to rabbit proteins or to any product excipients
* active acute or chronic infections
* latent tuberculosis
* leucopenia below 3000/μl
* lymphopenia below 400/μl
* thrombocytopenia below 75000/μl
* coagulation disorders
* active malignancy and pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05199103
Study Brief:
Protocol Section:
NCT05199103