Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291928
Status:
COMPLETED
Last Update Posted:
2012-11-12
First Post:
2006-02-14
Brief Title:
HuMax-CD20 in Active Rheumatoid Arthritis Phase III
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Double-blind Randomized Placebo Controlled Dose Escalation Multi-centerphase III Trial of HuMax-CD20 a Fully Human Monoclonal Anti-CD20antibody in Patients With Active Rheumatoid Arthritis Who Have Previously Failedone or More Disease Modifying Anti-rheumatic Drugs
Status:
COMPLETED
Status Verified Date:
2012-11
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 trial is primarily to investigate the safety profile of HuMax-CD20 in patients with active RA Furthermore the trial is designed to identify the dose levels to be used in future trials based on evaluations of safety pharmacokinetics and ACR and DAS responses
Detailed Description:
This trial consists of a double-blind placebo controlled dose escalation part with randomization to trial treatment within each of three sequential cohorts Part A and a parallel group part with randomization into one of four treatment arms Part B Patients in Parts A and B will receive two infusions of either HuMax-CD20 300 mg 700 mg or 1000 mg or placebo and will be followed for safety efficacy and pharmacokinetic measurements for 24 weeks Hereafter patients will be followed every 12 weeks until B-cells CD19 cells have returned to baseline levels For patients in Part B the follow-up visits at 36 and 48 weeks after initial trial treatment Follow-up Visits 1 and 2 will include additional measurements of safety and efficacy
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 |
|---|---|---|---|
| HX-CD20-403 | OTHER | GENMAB | None |