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

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ClinicalTrials.gov Identifier: NCT01305746
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : February 13, 2014
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: A-623 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : April 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01305746


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Sponsors and Collaborators
Anthera Pharmaceuticals

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01305746     History of Changes
Other Study ID Numbers: AN-SLE3322
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014

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