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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01305746
First received: February 25, 2011
Last updated: February 11, 2014
Last verified: February 2014

February 25, 2011
February 11, 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 ] [ 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
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Chile,   Colombia,   Hong Kong,   India,   Mexico,   Peru,   Philippines,   Taiwan
 
NCT01305746
AN-SLE3322
Yes
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