We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01305746
First Posted: March 1, 2011
Last Update Posted: February 13, 2014
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.
Information provided by (Responsible Party):
Anthera Pharmaceuticals
February 25, 2011
March 1, 2011
February 13, 2014
April 2011
July 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01305746 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321
An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)
The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
382
October 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Chile,   Colombia,   Hong Kong,   India,   Mexico,   Peru,   Philippines,   Taiwan,   United States
 
 
NCT01305746
AN-SLE3322
Yes
Not Provided
Not Provided
Anthera Pharmaceuticals
Anthera Pharmaceuticals
Not Provided
Not Provided
Anthera Pharmaceuticals
February 2014

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