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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01305746
First received: February 25, 2011
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Systemic Lupus Erythematosus
 Drug: A-623
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Anthera Pharmaceuticals:

Primary Outcome Measures:
  • To assess the long term safety of A-623 in subjects with SLE [ Time Frame: Until the drug is approved or the Sponsor discontinues the study ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 600
Study Start Date: April 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A-623 high dose weekly
High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
 Drug: A-623
High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
Experimental: A-623 low dose weekly
Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
 Drug: A-623
Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
Experimental: A-623 high dose every 4 weeks
High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
 Drug: A-623
High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305746

  Show 71 Study Locations
Sponsors and Collaborators
Anthera Pharmaceuticals
  More Information

No publications provided

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01305746     History of Changes
Other Study ID Numbers: AN-SLE3322
Study First Received: February 25, 2011
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Anthera Pharmaceuticals:
SLE
Lupus
Lupus Erythematosus, Systemic
 A-623
Autoimmune Diseases
Blisibimod

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

ClinicalTrials.gov processed this record on June 13, 2013