Study of LJP 394 (Abetimus Sodium) in Lupus Patients

Sponsor

La Jolla Pharmaceutical Company (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00390091

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

The primary purpose of this study is to assess the safety and pharmacodynamic effect of LJP 394 at doses of 100 mg, 300 mg and 900 mg on anti-dsDNA antibody levels in patients with SLE.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: abetimus sodium (LJP 394)	Phase 2

Detailed Description

STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Diagnostic

Official Title:

A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetic and Pharmacodynamic Effects of Abetimus Sodium in Patients With Systemic Lupus Erythematosus (SLE)

Study Start Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

The assessment of the safety and pharmacodynamic effect of abetimus sodium at []
doses of 100mg, 300mg, and 900mg in reducing the anti-dsDNA antibody levels in []
patients with SLE will be based on laboratory data from the central laboratory []
and confirmed by supporting data. The pharmacodynamic effic will be assessed []
using historical placebo effect as a control. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males or females between 12 and 70 years old.
Diagnosis of Systemic Lupus Erythematosus (SLE)
Females must be non-pregnant and non-lactating. Females must agree to use adequate birth control methods during the course of the study.
Ability to have weekly intravenous (IV) administration of study drug.