Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004816
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
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:
OBJECTIVES I Evaluate the safety and immunogenicity of single and multiple doses of M-T412 a chimeric murine-human anti-CD4 monoclonal antibody in patients with multiple sclerosis
II Evaluate the pharmacokinetics of M-T412 III Obtain preliminary data on the clinical response to M-T412
II Evaluate the pharmacokinetics of M-T412 III Obtain preliminary data on the clinical response to M-T412
Detailed Description:
PROTOCOL OUTLINE This is an open label dose escalating study Escalating doses of M-T412 are administered to cohorts of 5 patients each receiving a single dose intravenously over 2 hours
Patients who complete the single dose assessment of M-T412 may receive up to 3 additional single doses of M-T412 IV over 2 hours with each repeated dose given at least 1 month apart
Then patients receive one dose level of M-T412 IV over 2 hours at 3 month intervals over a period of 12 months for a total of 5 doses Once recovery of CD4 cells is obtained the next scheduled infusion of M-T412 begins Patients are omitted from study if CD4 cells remain attenuated following 2 scheduled infusion sessions
Patients are followed at 3 6 12 and 24 months after the first infusion
Patients who complete the single dose assessment of M-T412 may receive up to 3 additional single doses of M-T412 IV over 2 hours with each repeated dose given at least 1 month apart
Then patients receive one dose level of M-T412 IV over 2 hours at 3 month intervals over a period of 12 months for a total of 5 doses Once recovery of CD4 cells is obtained the next scheduled infusion of M-T412 begins Patients are omitted from study if CD4 cells remain attenuated following 2 scheduled infusion sessions
Patients are followed at 3 6 12 and 24 months after the first infusion
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SUMC-C0128T03 | None | None | None |