Study of Epratuzumab in Systemic Lupus Erythematosus

UCB

Status and phase: Terminated; Phase 3

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: epratuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00111306

EudraCT #: 2005-000705-59

SL0003 (IMMU-103-03)

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has SLE by ACR revised criteria (meets <4 criteria);
• Has SLE with at least one elevated lupus antibody;
• Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic

Exclusion criteria

• Active severe CNS or Renal disease defined by BILAG as Level A
• Allergy to murine or human antibodies
• Antiphospholid antibodies AND a history of thrombocytopenic events

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind