Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

UCB

Status and phase: Terminated; Phase 3

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Epratuzumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00383214

SL0004(IMMU-103-04)

EudraCT #: 2005-000706-31

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard treatments for patients with SLE.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• +ANA at screening
• BILAG Index B Level Activity in at least 2 body systems/organs
• Has SLE by ACR revised criteria (meets,<4 criteria)

Exclusion criteria

• Active Severe Lupus as defined by BILAG Index Level A in any body system or organ.
• Allergy to human antibodies or Murine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

Epratuzumab

Active Comparator group

Description:

360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion

Treatment:

Drug: Epratuzumab

Placebo

Placebo Comparator group

Description:

Intravenous

Treatment:

Other: Placebo