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 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT00501995
Eligibility Criteria:
Inclusion Criteria:
* Meet established criteria for a diagnosis of diffuse cutaneous scleroderma and have evidence of moderately severe organ damage and clinical evidence of active disease.
* Patients with diffuse scleroderma who have evidence of active fibrosing alveolitis manifested by either a greater than 10% decline in the forced vital capacity or the diffusing capacity from the defined normal values or from baseline measurements.
* Patients with severe deforming localized scleroderma (generalized morphea, liner morphea, keloid or bullous scleroderma) that threatens their capacity to function normally in society.
Exclusion Criteria:
* Age less than 18 years and over 70 years
* Any risk of pregnancy
* Cardiac ejection fraction of \< 45%
* Serum creatinine \> 3.0
* Patients who are pre-terminal or moribund
* Bilirubin \> 2.0, transaminases \> 2x normal
* Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), (5/30/01) \< 50% predicted
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00501995
Study Brief:
Protocol Section:
NCT00501995