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Study of LJP 394 (Abetimus Sodium) in Lupus Patients

Primary Purpose

Systemic Lupus Erythematosus

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
abetimus sodium (LJP 394)
Sponsored by
La Jolla Pharmaceutical Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Systemic Lupus Erythematosus focused on measuring Lupus, Nephritis, Kidney, SLE, Systemic Lupus Erythematosus, Nephritis, Lupus

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Wallace Rheumatic Study Center
  • Altoona Center for Clinical Research

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2006
Last Updated
August 31, 2015
Sponsor
La Jolla Pharmaceutical Company
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1. Study Identification

Unique Protocol Identification Number
NCT00390091
Brief Title
Study of LJP 394 (Abetimus Sodium) in Lupus Patients
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 Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Withdrawn
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
La Jolla Pharmaceutical Company

4. Oversight

5. 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.
Detailed Description
STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Lupus, Nephritis, Kidney, SLE, Systemic Lupus Erythematosus, Nephritis, Lupus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
abetimus sodium (LJP 394)
Primary Outcome Measure Information:
Title
The assessment of the safety and pharmacodynamic effect of abetimus sodium at
Title
doses of 100mg, 300mg, and 900mg in reducing the anti-dsDNA antibody levels in
Title
patients with SLE will be based on laboratory data from the central laboratory
Title
and confirmed by supporting data. The pharmacodynamic effic will be assessed
Title
using historical placebo effect as a control.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew D Linnik, PhD
Organizational Affiliation
La Jolla Pharmaceutical Company
Official's Role
Study Chair
Facility Information:
Facility Name
Wallace Rheumatic Study Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ljpc.com
Description
Sponsor's website
URL
http://clinicaltrials.gov/ct/show/NCT00089804?order=1
Description
STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804

Learn more about this trial

Study of LJP 394 (Abetimus Sodium) in Lupus Patients

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