Study of Epratuzumab in Systemic Lupus Erythematosus

UCB

Status and phase: Completed; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: Epratuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00383513

SL0006

EudraCT #: 2006-004496-36

Details and patient eligibility

About

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.

Full 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).

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Epratuzumab

Experimental group

Treatment:

Biological: Epratuzumab