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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT00176592
Eligibility Criteria:
Inclusion criteria:
Patients must meet all of the following criteria at the time of the baseline visit in order to enter the trial:
* Be Between 18 and 55 years of age, at baseline.
* Be capable of informed consent in English prior to any study related procedures.Spanish speaking patients who do not read English well can give written informed consent if a relative or friend fluent in both English and Spanish has translated the consent and any questions the patient may have.
* Be available and willing to complete all study assessments.
* Presently meet one of the two following forms of multiple sclerosis:
1. Relapsing-remitting ms plus evidence of recent disease activity as shown by the development of one or more clinical and/or MRI lesions during the 6 months prior to entry into the study.
2. A CIS consistent with central nervous system (CNS) demyelination confirmed on ophthalmologic or neurological examination with onset within 6 months prior to study entry. Also:a- evidence of dissemination in space, there should be two or more brain MRI lesions ≥ 3 mm in size at least one of which should be ovoid and/or periventricular in location; and b- As evidence of dissemination in time, if the CIS is acute (≤1 month) there should be one or more non-enhancing lesion or if the CIS is not acute (older than 1 month) the MRI should show one or more enhancing lesions.
* At baseline, have an EDSS between 0-5.5.
* Females of childbearing potential must agree to practice adequate contraception methods. All females must have negative pregnancy test results at screening and a negative urine pregnancy test at baseline.
* Screening laboratory results that confirm adequate bone marrow, renal, and hepatic function.
Exclusion criteria
Patients were not permitted into the study if they met any of the following criteria:
* Onset of a relapse between screening and Study Day 1.
* Present evidence or history of any conditions that could affect the CNS or interfere with the MRI results or any other evaluation in the study.
* Possess any of the standard metallic devices or foreign bodies that are contraindications for MRI.
* Patient weight and or size unable to fit in the 3T MRI scanner.
* Pregnancy, as denoted by a positive serum pregnancy test at screening visit or a positive urine pregnancy test at the baseline visit. Subjects who are breast-feeding are also excluded.
* Have a known allergy or hypersensitivity to Gadolinium-chelates, human proteins including albumin and interferons, or Glatiramer Acetate or Mannitol.
* Uncontrolled, clinically significant heart diseases, such as dysrhythmias, angina, or uncompensated congestive heart failure. History of or current unstable medical conditions that could be deemed clinically significant.
* Intolerance or any contraindication to acetaminophen, ibuprofen, or steroids.
* Inability, in the opinion of the principal investigator or staff, to be compliant with protocol requirements for the duration of the study.
* Participation in any clinical trial within the past six months
* History or present evidence of addictions.
* Have active peptic ulcer disease.
* Inability to have subcutaneous injections administered.
* Medical, psychiatric or other conditions that compromise the patient's ability to understand the study procedures.
* Claustrophobia.
* Uncontrolled head movements.
* Treatment with any of the following in the indicated time frames: Any of the Interferons for \> 6 months· Glatiramer acetate (Copaxone) for \> 6 months.No prior use allowed of Total lymphoid irradiation, Anti-lymphocyte monoclonal antibody (e.g.(Campath-1H) .Mitoxantrone,cyclophosphamide, Azathioprine, intravenous immunoglobulin (IVIG), cyclosporine within 6 months before the screening visit·Any investigational drug 21 days before screening visit·Systemic corticosteroids·ACTH from screening visit through Study Day
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00176592
Study Brief:
Protocol Section:
NCT00176592