Ignite Creation Date:
2024-05-05 @ 10:32 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01135459
Status:
COMPLETED
Last Update Posted:
2022-12-16
First Post:
2010-06-01
Brief Title:
A Study to Evaluate the Efficacy and Safety of CEP-33457 in Participants With Systemic Lupus Erythematosus SLE
Sponsor:
Cephalon Inc
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Randomized Double-Blind Parallel-Group Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus
Status:
COMPLETED
Status Verified Date:
2022-11
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 primary objective of this study is to evaluate the efficacy of a 200 micrograms mcg dose of CEP-33457 compared with placebo in participants with active systemic lupus erythematosus SLE as assessed by the proportion of participants achieving a combined clinical response using the SLE responder index SRI at Week 24
Detailed Description:
The study consisted of a 2-week screening period visit 1 a 20-week treatment period beginning with a baseline visit in which randomization was completed and study drug treatment began visits 2 through 7 and a final assessment was performed 4 weeks after the last dose of study drug visit 8 week 24 or early termination Participants were randomized to receive either CEP-33457 or placebo subcutaneously SC every 4 weeks Plasma samples for measurement of study drug concentration were collected in a subset of participants and study drug was administered at each study visit until the final visit The dose of background steroid medication may have been increased if needed to treat the participant for minor fluctuations in lupus disease activity One interim analysis was conducted when at least 80 participants completed Week 12 or had been withdrawn from the study Participants who completed the treatment period returned to the study center 4 weeks after the last dose had been administered for final procedures and assessments Final procedures and assessments for participants who withdrew from the study before 20 weeks of treatment were performed at the last visit Final procedures and assessments for participants who participated in the study beyond week 24 were to be performed at the next regularly scheduled visit Participants who complete the study will be eligible for participation in the 12-month open-label study study C334573075 herein referred to as study 3075 to assess continued effectiveness and safety of the CEP-33457 treatment
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