Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042406
Status:
TERMINATED
Last Update Posted:
2023-04-28
First Post:
2002-07-29
Brief Title:
Trial With HuMax-CD4 in Participants With Rheumatoid Arthritis RA Failing Treatment With Methotrexate MTX and a TNF-alpha Blocker
Sponsor:
Genmab
Organization:
Genmab
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Randomized Parallel Group Clinical Trial of Anti-CD4 Receptor Human Monoclonal Antibody HuMax-CD4 in Patients With Active Rheumatoid Arthritis Failing Treatment With Methotrexate and TNF-alpha Blocking Agents
Status:
TERMINATED
Status Verified Date:
2023-04
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:
The purpose of this study is to determine whether HuMax-CD4 is effective in the treatment of active RA in participants who have failed treatment with MTX and at least one TNF-alpha blocking agent
Detailed Description:
This is a multi-center double-blind placebo-controlled parallel-group randomized trial of HuMax-CD4 in the treatment of participants with active RA who have failed treatment with MTX and at least one TNF-alpha blocking agent Participants are randomized to receive one of two doses of HuMax-CD4 or placebo The drug will be administered as a subcutaneous infusion given just under the skin more often in the beginning and then followed by a maintenance dose There is a 4 week follow up period and the final evaluation of the clinical endpoints takes place 26 weeks after treatment start The trial lasts about 28 weeks in all
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None