Study of LJP 394 (Abetimus Sodium) in Lupus Patients

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier:
NCT00390091
First received: October 17, 2006
Last updated: February 5, 2007
Last verified: February 2007
  Purpose

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 Intervention Phase
Systemic Lupus Erythematosus
Drug: abetimus sodium (LJP 394)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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)

Resource links provided by NLM:


Further study details as provided by La Jolla Pharmaceutical Company:

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.

Estimated Enrollment: 45
Study Start Date: September 2006
Detailed Description:

STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390091

Locations
United States, California
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
La Jolla Pharmaceutical Company
Investigators
Study Chair: Matthew D Linnik, PhD La Jolla Pharmaceutical Company
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00390091     History of Changes
Other Study ID Numbers: LJP 394-90-16
Study First Received: October 17, 2006
Last Updated: February 5, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by La Jolla Pharmaceutical Company:
Lupus
Nephritis
Kidney
SLE
Systemic Lupus Erythematosus
Nephritis, Lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014