Study of LJP 394 (Abetimus Sodium) in Lupus Patients | NCT00390091

Studies
Study of LJP 394 (Abetimus Sodium) in Lupus Patients

NCT00390091

Sponsor

La Jolla Pharmaceutical Company

Status

Withdrawn

Last Update Posted

Sep 1, 2015Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Systemic Lupus Erythematosus

Interventions

abetimus sodium (LJP 394)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 17, 2006

First Submission Date that Met QC Criteria

Oct 17, 2006

First Posted Date

Oct 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2015

Last Update Posted Date

Sep 1, 2015Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
abetimus sodium (LJP 394)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew D Linnik, PhD	La Jolla Pharmaceutical Company	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wallace Rheumatic Study Center		Los Angeles	California	90048	United States
Altoona Center for Clinical Research

Label	URL
Sponsor's website	View source
STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804	View source

Condition Browse Module

MeSH Terms

ID	Term
D008180	Lupus Erythematosus, Systemic
D009393	Nephritis
D008181	Lupus Nephritis

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

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