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

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

Tracking Information
First Submitted Date  ICMJE February 25, 2011
First Posted Date  ICMJE March 1, 2011
Last Update Posted Date February 13, 2014
Study Start Date  ICMJE April 2011
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321
Official Title  ICMJE An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)
Brief Summary The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: A-623
  • 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
    Intervention: Drug: A-623
  • 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
    Intervention: Drug: A-623
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2014)
382
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2011)
600
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Chile,   Colombia,   Hong Kong,   India,   Mexico,   Peru,   Philippines,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01305746
Other Study ID Numbers  ICMJE AN-SLE3322
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthera Pharmaceuticals
Study Sponsor  ICMJE Anthera Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Anthera Pharmaceuticals
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP