A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321

Phase 2CompletedNCT01305746

Anthera Pharmaceuticals382 enrolled

Overview

The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

382

Conditions

Systemic Lupus Erythematosus

Interventions

A-623DRUG

High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

A-623DRUG

Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

A-623DRUG

High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Completed the treatment period specified in study AN-SLE3321 or were enrolled in study AN-SLE3321 prior to November 30, 2010 Exclusion Criteria: * Developed a new medical disease or condition that has made the subject unsuitable for this study in the opinion of the Investigator, including interference with written informed consent, study evaluation, completion, and/or procedures * Pregnant or nursing * Any prior administration of a B-cell modulating therapy other than A-623 * Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to listed wash-out periods

Locations (71)

Outcomes

Primary Outcomes

To assess the long term safety of A-623 in subjects with SLE

Safety assessments such as AEs, SAEs, vital signs, ECG, clinical chemistry, hematology, and immunogenicity will be analyzed in a descriptive manner and will include infections, malignancies, injection site reactions and immunogenicity, neuropsychiatric events, and deaths

Time frame: Until the drug is approved or the Sponsor discontinues the study

Data from ClinicalTrials.gov

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Investigator Site 103

Birmingham, Alabama, United States

Investigator Site 113

Long Beach, California, United States

Investigator Site 110

Upland, California, United States

Investigator Site 105

Orlando, Florida, United States

Investigator Site 102

Tampa, Florida, United States

Investigator Site 117

Baltimore, Maryland, United States

Investigator Site 104

Lansing, Michigan, United States

Investigator Site 106

Lake Success, New York, United States

Investigator Site 114

Smithtown, New York, United States

Investigator Site 101

Greenville, North Carolina, United States

...and 61 more locations