Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

UCB

Status and phase

Terminated

Phase 2

Conditions

Lupus Erythematosus, Systemic

Treatments

Drug: epratuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00113971

SL0002 (IMMU-103-SLE-02)

Details and patient eligibility

About

The goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE.

Full description

This study is planned to provide information on how the body processes epratuzumab and how epratuzumab affects the body when epratuzumab is given once weekly for 4 weeks in a row at one of 2 different dose levels. Additional information will be obtained related to the natural variability of disease activity in SLE patients.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Has SLE by American College of Rheumatology revised criteria (meets >/= 4 criteria)
Has had SLE for at least 6 months prior to study entry
Has at least one elevated autoantibody level at study entry
Has moderately active SLE disease at study entry in any body/organ system (Full criteria not present here due to length of considerations. The protocols should be consulted regarding the complete list of entry 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
Prior therapy with other anti-B cell antibodies