Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis
This study is enrolling participants by invitation only.
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University of Chicago
First received: July 13, 2011
Last updated: January 23, 2014
Last verified: January 2014
The MRI study is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis
Primary Outcome Measures:
- Diffusion and myelin fraction water changes on MRI [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Changes in normal appearing white matter from baseline through month 24.
The MRI is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2015 (Final data collection date for primary outcome measure)
Single arm, single cohort study, all subjects will be dosed with alemtuzumab.
10 mg/ml alemtuzumab intravenous infusion, sterile clear, colorless solution. dosage: 2 cycles. Month 0 dosed over 5 consecutive days: month 12 dosed over 3 consecutive days.
To identify specific changes in T cell subsets and functions in Relapsing Remitting Multiple Sclerosis.
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Signed, informed consent form (ICF)
- Age 18 to 50 years old (inclusive) as of signing the ICF
- 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 (as determined by a neurologist) within 15 years of screening
- 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
- Subjects previously enrolled and randomized to interferon beta 1a in the CARE-MS 323 and 324 studies, and who will be treated with Alemtuzumab through the CARE-MS extension study will be eligible to participate in the immunology and MRI studies of this protocol.
- Received prior therapy for MS other than corticosteroids within 28 days of screening; e.g., interferons, 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, e.g, deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation
- Latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis. Patients will be assessed for this risk based on a screening questionnaire.
- 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 that, in the Investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
- Confirmed platelet count < the lower limit of normal (LLN) of the evaluating laboratory at Screening or documented at <100,000/uL within the past year on a sample without clumping
- Prior history of invasive fungal infections
- Cervical high risk human papillomavirus (HPV) positivity or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS). The patient may be eligible after the condition has been effectively treated (eg, follow-up HPV test is negative or cervical abnormality has been treated).
- 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. See Table below, drawn from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE), published 09 August 2006
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01395316
University of Chicago
Genzyme, a Sanofi Company
||Adil Javed, MD
||University of Chicago
No publications provided
||University of Chicago
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 13, 2011
||January 23, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 22, 2014
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases