NCT00390091

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
Last Updated

September 1, 2015

Status Verified

February 1, 2007

First QC Date

October 17, 2006

Last Update Submit

August 31, 2015

Conditions

Systemic Lupus Erythematosus

Keywords

LupusNephritisKidneySLESystemic Lupus ErythematosusNephritis, Lupus

Outcome Measures

Primary Outcomes (5)

  • 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.

Interventions

abetimus sodium (LJP 394)DRUG

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Prior exposure to abetimus sodium within 6 months prior to screening.
  • Patients not on stable medications for 30 days prior to screening.
  • Patients with acute or chronic infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wallace Rheumatic Study Center

Los Angeles, California, 90048, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Related Links

MeSH Terms

Conditions

Lupus Erythematosus, SystemicNephritisLupus Nephritis

Interventions

abetimus

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGlomerulonephritis

Study Officials

  • Matthew D Linnik, PhD

    La Jolla Pharmaceutical Company

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 19, 2006

Study Start

September 1, 2006

Last Updated

September 1, 2015

Record last verified: 2007-02

Locations

US(2)