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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT01307332
Eligibility Criteria:
Inclusion Criteria:
* Signed, informed consent form
* Age 18 to 50 years old (inclusive)
* Diagnosis of MS per update of McDonald criteria, and cranial MRI scan demonstrating white matter lesions attributable to MS within 10 years of screening
* Onset of MS symptoms within 15 years of screening
* Neurostatus (EDSS) score 0.0 to 5.0 (inclusive)
* 2 MS attacks (first episode or relapse) occurring in the 24 months prior to screening, with 1 attack in the 12 months prior to screening, with objective neurological signs confirmed by a physician.
Exclusion Criteria:
* Received prior therapy for MS other than corticosteroids within 28 days of screening; e.g., interferon's, IV immunoglobulin, and glatiramer acetate
* Exposure to natalizumab within 6 months of screening
* Any prior exposure to mitoxantrone, mycophenolate mofetil, azathioprine, cladribine, cyclophosphamide, cyclosporine A, methotrexate, rituximab, or any other immunosuppressive agent other than systemic corticosteroid treatment
* Has any progressive form of MS
* History of malignancy (exception for basal cell skin carcinoma)
* Previous hypersensitivity reaction to other immunoglobulin product
* Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
* CD4+, CD8+, or CD19+ (i.e., absolute CD3+CD4+, CD3+CD8+, or CD19+/mm3) count \<LLN at Screening; if abnormal cell count(s) return to within normal limits, eligibility may be reassessed
* Seropositivity for human immunodeficiency virus (HIV)
* Significant autoimmune disease (e.g, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders; vasculitis; inflammatory bowel disease; severe psoriasis)
* Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies
* Active infection
* Latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.
* Infection with hepatitis B virus or hepatitis C virus
* Of childbearing potential with a positive serum pregnancy test
* Unwilling to agree to use a reliable and acceptable contraceptive method throughout the study period
* Major psychiatric disorder that is not adequately controlled by treatment
* Epileptic seizures that are not adequately controlled by treatment
* Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety or interfere with the interpretation of study results
* Medical, psychiatric, cognitive, or other conditions
* Confirmed platelet count the lower limit of normal (LLN) of the evaluating laboratory at Screening or documented at 100,000/L within the past year on a sample without clumping
* Prior history of invasive fungal infections
* Cervical high risk human papilloma virus (HPV) positivity or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS).
* Seropositive for Trypanosoma cruzi or the Human T-lymphotropic virus type I or type II (HTLV-I/II) (testing required in endemic regions only)
* Any other illness or infection (latent or active) that, in the Investigator's opinion, could be exacerbated by alemtuzumab treatment
* Any hepatic or renal function value grade 2 or higher at Screening, with the exception of hyperbilirubinemia due to Gilbert's syndrome.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01307332
Study Brief:
Protocol Section:
NCT01307332