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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT01785056
Eligibility Criteria:
Inclusion Criteria:
* Diffuse systemic sclerosis with active skin involvement as defined as a mRSS \>12, with no improvement or worsening in the previous 4 months in spite of treatment with methotrexate, cellcept, imuran, or anti-TNF agent;
* 18 years of age or older;
* Disease duration of less than 5 years from the first non-Raynaud's symptom of scleroderma.
Exclusion Criteria:
* Use of more than 10 mg of prednisone, or any dose of cytoxan, d-penicillamine, or rituximab in the last 3 months;
* History of deep vein thrombosis (DVT), stroke, or other thromboembolic phenomenon;
* History of anaphylaxis or other serious reaction to human blood or blood products.
* Absolute IgA deficiency
* A prior receipt of IVIg treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01785056
Study Brief:
Protocol Section:
NCT01785056