Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001934
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
1999-11-03
Brief Title:
Zenapax to Treat Multiple Sclerosis
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effect of the Humanized Monoclonal Antibody Against the Interleukin-2 Receptor Alpha Subunit IL-2R-Alpha ZenapaxRegistered Trademark on Inflammatory Activity in the CNS in MS in a Baseline-to-Treatment Cross-Over MRI-Controlled Single Center Phase III Trial
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the safety and effectiveness of Zenapax a laboratory-manufactured antibody in treating multiple sclerosis Multiple sclerosis may be caused by an abnormal immune response in which white blood cells called T lymphocytes attack the myelin sheath that covers nerves and parts of the spinal cord Zenapax binds to protein receptors on lymphocytes keeping them from interacting with interleukin-2 a substance necessary for their growth
Patients with multiple sclerosis who have had at least one relapse within 18 months of the start of the study and in whom interferon-beta treatment has not been successful may be considered for this study There are two study phases baseline and treatment During the baseline phase patients will have three magnetic resonance imaging MRI scans over 2 months to evaluate their disease activity During treatment patients will receive seven intravenous IV infusions of Zenapax in the clinic The first two infusions will be given 2 weeks apart the next five will be given once a month
Patients will have MRI scans before each infusion The MRIs will be done using the standard procedure and again using a contrast agent gadolinium injected into a vein Gadolinium helps identify new multiple sclerosis lesions in the brain Blood and urine samples will be taken during each clinic visit In addition patients will have skin tests similar to a tuberculin test to evaluate immune status and will be asked to undergo two lumbar punctures spinal tap these will be optional-one before the treatment phase begins and another when treatment is completed Lymphocytes will also be collected from patients before during and after treatment The lymphocytes are obtained by a procedure called apheresis about a pint of whole blood is drawn through a needle in the arm the lymphocytes are separated out and removed by a machine and the rest of the blood is returned through a needle in the other arm These studies will hopefully allow conclusions about the safety of Zenapax in MS but also address its effectiveness with respect to modifying the inflammatory activity in the brain of MS patients and inhibit autoimmune T lymphocytes that are involved in the disease process
Patients with multiple sclerosis who have had at least one relapse within 18 months of the start of the study and in whom interferon-beta treatment has not been successful may be considered for this study There are two study phases baseline and treatment During the baseline phase patients will have three magnetic resonance imaging MRI scans over 2 months to evaluate their disease activity During treatment patients will receive seven intravenous IV infusions of Zenapax in the clinic The first two infusions will be given 2 weeks apart the next five will be given once a month
Patients will have MRI scans before each infusion The MRIs will be done using the standard procedure and again using a contrast agent gadolinium injected into a vein Gadolinium helps identify new multiple sclerosis lesions in the brain Blood and urine samples will be taken during each clinic visit In addition patients will have skin tests similar to a tuberculin test to evaluate immune status and will be asked to undergo two lumbar punctures spinal tap these will be optional-one before the treatment phase begins and another when treatment is completed Lymphocytes will also be collected from patients before during and after treatment The lymphocytes are obtained by a procedure called apheresis about a pint of whole blood is drawn through a needle in the arm the lymphocytes are separated out and removed by a machine and the rest of the blood is returned through a needle in the other arm These studies will hopefully allow conclusions about the safety of Zenapax in MS but also address its effectiveness with respect to modifying the inflammatory activity in the brain of MS patients and inhibit autoimmune T lymphocytes that are involved in the disease process
Detailed Description:
Multiple sclerosis MS is an inflammatory and demyelinating disease of the central nervous system CNS that preferentially affects young adults While its etiology is unknown current concepts assume that CD4 helper T cells with specificity for components of the myelin sheath initiate the pathogenetic process The activation and expansion of such autoreactive T cells involves the secretion of autocrine growth factors particularly interleukin-2 IL-2 and the concomitant expression of its receptor IL-2R on the surface of T cells Since only activated T lymphocytes can migrate through the blood brain barrier into the CNS and induce the inflammatory process blocking the IL-2R should have an impact on disease activity in MS
In this trial a humanized antibody against the IL-2Ra subunit ZenapaxRegistered Trademark will be used to inhibit T cell activation in MS patients who have failed conventional therapy by interferon-b We will focus on the latter group of patients since a substantial number of patients on conventional therapy respond only partially or completely fail treatment after longer periods of time Up to 10 patients fulfilling these criteria will be enrolled in this baseline-to-treatment cross-over MRI-controlled single-center phase III trial to assess the safety of ZenapaxRegistered Trademark treatment and at the same time examine the clinical course and particularly the inflammatory activity in the CNS by monthly magnetic resonance imaging MRI Furthermore immunological studies will be performed in parallel to the trial in order to a identify the impact of ZenapaxRegistered Trademark treatment on immune parameters that should be affected by the blocking of the IL-2R and b to improve our understanding of the relevance of activated autoreactive T lymphocytes in MS
In this trial a humanized antibody against the IL-2Ra subunit ZenapaxRegistered Trademark will be used to inhibit T cell activation in MS patients who have failed conventional therapy by interferon-b We will focus on the latter group of patients since a substantial number of patients on conventional therapy respond only partially or completely fail treatment after longer periods of time Up to 10 patients fulfilling these criteria will be enrolled in this baseline-to-treatment cross-over MRI-controlled single-center phase III trial to assess the safety of ZenapaxRegistered Trademark treatment and at the same time examine the clinical course and particularly the inflammatory activity in the CNS by monthly magnetic resonance imaging MRI Furthermore immunological studies will be performed in parallel to the trial in order to a identify the impact of ZenapaxRegistered Trademark treatment on immune parameters that should be affected by the blocking of the IL-2R and b to improve our understanding of the relevance of activated autoreactive T lymphocytes in MS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-N-0169 | None | None | None |