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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT00232193
Eligibility Criteria:
Inclusion Criteria:
* male and female patients between the ages of 18-55 years inclusive
* have provided informed consent to be screened for the study
* have been diagnoses as having MS
* meet the McDonald diagnostic criteria for RRMS or CHAMPS criteria for CIS
* have an EDSS score of 0.0-3.5
* have had no immunomodulator or cytoxic agents and have had no steroids or other immunosuppressants within 30 days prior to Baseline Visit
* must have had a brain MRI scan demonstrating lesions consistent with MS on T2-weighted or FLAIR images
* subjects must be willing and able to participate in all aspects of the study, including use of study medications as prescribed, and screening and follow-up clinical and MRI assessments
Exclusion Criteria:
* type I of type II diabetes
* uncontrolled hypertension (systolic \>160 or diastolic \>100 despite medication therapy)
* history of suicidal ideation
* history of psychosis
* history of alcoholism or other substance abuse
* clinically significant coronary artery disease
* history of hepatic failure and chronic renal failure
* history of cancer other than basal or squamous cell carcinoma of the skin
* pregnancy or unwillingness to use adequate precautions to prevent pregnancy during the duration of this study
* nursing mothers
* history of stroke, dementia, seizure disorder, peripheral neuropathy, Parkinsonism, myasthenia, myelopathy or other primary degenerative disease of the central or peripheral nervous system
* history of peptic ulcer disease
* history of intolerance to corticosteroids or allergy to albumin
* history of osteoporosis
* history of Lupus, Sjogrens syndrome, Lyme disease or syphilis
* abnormal laboratory results indicative of significant hepatic, renal, hematopoetic, or coagulation dysfunction
* the entity of any disease entity, which in the opinion of the investigators would potentially prevent the patient from successfully completing 2 years participation in this trial or confound the observations made during this trial
* prior use of Avonex, Betaseron, Rebif, mitoxantrone, cyclophosphamide, azothioprine, methotrexate, cladribine, cyclosporin, CellCept, IVIG, natalizumab, anti T-cell or anti B-cell antibodies, plasmapheresis or other systemic immunosuppressant or cancer chemotherapeutic agents
* unwillingness or inability to comply with all the requirements of the protocol
* known diagnosis of osteoporosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00232193
Study Brief:
Protocol Section:
NCT00232193