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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT00016458
Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Diagnosis of diffuse systemic sclerosis
Progressive disease Skin score at least 16 Interstitial or pulmonary vasculitis (FVC or DLCO no greater than 70% predicted) with evidence of alveolitis by bronchoalveolar lavage (BAL) Proteinuria (more than 500 mg/24 hours) Rapid deterioration in pulmonary function (at least 15% decrease in FVC or DLCO within the past 6 months) or new evidence of alveolitis by CT scan changes or BAL
No acute renal failure secondary to systemic sclerosis crisis
DLCO greater than 20% predicted
Ineligible for or refused autologous or allogeneic peripheral blood stem cell or bone marrow transplantation
--Prior/Concurrent Therapy--
Endocrine therapy: Concurrent prednisone allowed if prior chronic use
Other: At least 4 days since prior immunosuppressive therapy
--Patient Characteristics--
Performance status: Karnofsky 50-100%
Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin less than 2.5 times upper limit of normal (ULN) SGOT less than 2.5 times ULN
Renal: See Disease Characteristics Creatinine clearance at least 35 mL/min No requirement for renal dialysis
Cardiovascular: Ejection fraction greater than 45% No myocardial infarction within the past 12 months No unstable angina No uncontrolled cardiac arrhythmias No evidence of congestive heart failure
Pulmonary: See Disease Characteristics
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No active uncontrolled infection
* No hypersensitivity to rabbit proteins
* No prior hemorrhagic cystitis requiring transfusion
* No concurrent active hemorrhagic cystitis by cystoscopy (if prior history)
* No concurrent malignancy
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
64 Years
Study:
NCT00016458
Study Brief:
Protocol Section:
NCT00016458