Clinical trial NCT00383513: Study of Epratuzumab in Systemic Lupus Erythematosus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Antibody
B-Cell Immunotherapy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-10-03
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years)
timeFrame: From Entry Visit 1 through end of treatment (approximately 6 years)
measure: Number of subjects prematurely discontinuing due to a treatment emergent adverse event (TEAE) from entry Visit 1 through end of treatment (approximately 6 years)
timeFrame: From Entry Visit 1 through end of treatment (approximately 6 years)
Secondary outcomes:
measure: Time to treatment failure from First Visit through end of treatment (approximately 6 years)
timeFrame: From the first infusion of the first treatment cycle and continuing through end of treatment (approximately 6 years)
measure: Epratuzumab plasma concentration levels at Week 0
timeFrame: Week 0
measure: Epratuzumab plasma concentration levels at Week 48
timeFrame: Week 48
measure: Epratuzumab plasma concentration levels at Week 96
timeFrame: Week 96
measure: Epratuzumab plasma concentration levels at Week 144
timeFrame: Week 144
measure: Epratuzumab plasma concentration levels at Week 192
timeFrame: Week 192
measure: Epratuzumab plasma concentration levels at Week 240
timeFrame: Week 240
measure: Subject Epratuzumab plasma concentration levels at Week 288
timeFrame: Week 288
measure: Number of subjects with anti-epratuzumab antibody in plasma at Week 0
timeFrame: Week 0
measure: Number of subjects with anti-epratuzumab antibody in plasma at Week 48
timeFrame: Week 48
measure: Number of subjects with anti-epratuzumab antibody in plasma at Week 96
timeFrame: Week 96
measure: Number of subjects with anti-epratuzumab antibody in plasma at Week 144
timeFrame: Week 144
measure: Number of subjects with anti-epratuzumab antibody in plasma at Week 192
timeFrame: Week 192
measure: Number of subjects with anti-epratuzumab antibody in plasma at Week 240
timeFrame: Week 240
measure: Number of subjects with anti-epratuzumab antibody in plasma at Week 288
timeFrame: Week 288
measure: Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Score
timeFrame: Baseline, Last Visit
measure: Change from Baseline in Short Form 36-items Health Survey (SF-36) Mental Composite Summary (MCS) Score
timeFrame: Baseline, Last Visit
measure: Change from Baseline in Patient's Global Assessment of Disease Activity (PtGADA)
timeFrame: Baseline, Last Visit
measure: Change from Baseline in Physician's Global Assessment of Disease Activity (PGADA)
timeFrame: Baseline, Last Visit
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Upland
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Baltimore
country: United States
state: Maryland
city: Durham
country: United States
state: North Carolina
city: Tulsa
country: United States
state: Oklahoma
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: