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Study of LJP 394 (Abetimus Sodium) in Lupus Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00390091
Recruitment Status : Withdrawn
First Posted : October 19, 2006
Last Update Posted : September 1, 2015
Sponsor:
Information provided by:

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  (Clinical Trial)
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 : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00390091     History of Changes
Other Study ID Numbers: LJP 394-90-16
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: February 2007

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