Study of Epratuzumab in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

An Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383513
• Other study ID #: SL0006
• Secondary ID: EudraCT #: 2006-
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2006
• Last updated: July 3, 2012
• Start date: June 2006
• Est. completion date: January 2012

Study information

• Verified date: July 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of Epratuzumab.

Description:

Due to the logistical considerations, UCB has decided to consolidate the Phase II and Phase III open-label extension trials. Subjects completing this study will be offered the option of continuing to receive epratuzumab through participation in Phase III open-label extension study SL0012 (NCT01408576).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have participated in SL0003 or SL0004 and benefitted from participation in those studies

Exclusion Criteria:

• Development of toxicity to epratuzumab

• Significant protocol deviations during the SL0003 or SL0004 studies

• Evidence of significant infection

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• Epratuzumab
360 mg/m^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting = 1 hour

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years)		From Entry Visit 1 through end of treatment (approximately 6 years)	No
Primary	Number of subjects prematurely discontinuing due to a treatment emergent adverse event (TEAE) from entry Visit 1 through end of treatment (approximately 6 years)		From Entry Visit 1 through end of treatment (approximately 6 years)	No
Secondary	Time to treatment failure from First Visit through end of treatment (approximately 6 years)	Treatment failure is defined as initiation of a protocol specified prohibited medication.	From the first infusion of the first treatment cycle and continuing through end of treatment (approximately 6 years)	No
Secondary	Epratuzumab plasma concentration levels at Week 0		Week 0	No
Secondary	Epratuzumab plasma concentration levels at Week 48		Week 48	No
Secondary	Epratuzumab plasma concentration levels at Week 96		Week 96	No
Secondary	Epratuzumab plasma concentration levels at Week 144		Week 144	No
Secondary	Epratuzumab plasma concentration levels at Week 192		Week 192	No
Secondary	Epratuzumab plasma concentration levels at Week 240		Week 240	No
Secondary	Subject Epratuzumab plasma concentration levels at Week 288		Week 288	No
Secondary	Number of subjects with anti-epratuzumab antibody in plasma at Week 0		Week 0	No
Secondary	Number of subjects with anti-epratuzumab antibody in plasma at Week 48		Week 48	No
Secondary	Number of subjects with anti-epratuzumab antibody in plasma at Week 96		Week 96	No
Secondary	Number of subjects with anti-epratuzumab antibody in plasma at Week 144		Week 144	No
Secondary	Number of subjects with anti-epratuzumab antibody in plasma at Week 192		Week 192	No
Secondary	Number of subjects with anti-epratuzumab antibody in plasma at Week 240		Week 240	No
Secondary	Number of subjects with anti-epratuzumab antibody in plasma at Week 288		Week 288	No
Secondary	Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Score		Baseline, Last Visit	No
Secondary	Change from Baseline in Short Form 36-items Health Survey (SF-36) Mental Composite Summary (MCS) Score		Baseline, Last Visit	No
Secondary	Change from Baseline in Patient's Global Assessment of Disease Activity (PtGADA)	Five point scale where 1 = very poor and 5 = very good.	Baseline, Last Visit	No
Secondary	Change from Baseline in Physician's Global Assessment of Disease Activity (PGADA)	Five point scale where 1 = very poor and 5 = very good.	Baseline, Last Visit	No