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PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus (PEARL-SC)

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ClinicalTrials.gov Identifier: NCT01162681
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : March 4, 2014
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 13, 2010
First Posted Date  ICMJE July 15, 2010
Last Update Posted Date March 4, 2014
Study Start Date  ICMJE July 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
SLE response [ Time Frame: Various timepoints through Week 52 ]
The % of subjects with SLE response compared with baseline at the time of assessment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01162681 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2010)
  • B cell reduction [ Time Frame: Various timepoints through Week 52 ]
  • Time to first flare [ Time Frame: Various timepoints through Week 52 ]
  • FACIT-fatigue score [ Time Frame: Various timepoints through Week 52 ]
  • Reduction in prednisone dose [ Time Frame: Various timepoints through Week 52 ]
  • Change in IgG, IgM,C3 and C4 [ Time Frame: Various timepoints through Week 52 ]
  • Flare rates [ Time Frame: Various timepoints through Week 52 ]
  • SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9 [ Time Frame: Various timepoints through Week 52 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
  • B cell reduction [ Time Frame: Various timepoints through Week 52 ]
    The percent reduction from baseline in total B cells at the time of assessment
  • Time to first flare [ Time Frame: Various timepoints through Week 52 ]
    Time to first flare after randomization
  • FACIT-fatigue score [ Time Frame: Various timepoints through Week 52 ]
    Change in FACIT score from baseline
  • Reduction in prednisone dose [ Time Frame: Various timepoints through Week 52 ]
    The percent of subjects with a reduction in average prednisone dose
  • Change in IgG, IgM,C3 and C4 [ Time Frame: Various timepoints through Week 52 ]
    Change in IgG, IgM, C3, C4 and anti-ds DNA values from baseline and post-baseline time periods
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
Official Title  ICMJE A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
Brief Summary The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: A-623
    High dose given subcutaneously once a week for up to 52 weeks
  • Drug: A-623
    Low dose given subcutaneously once a week for up to 52 weeks
  • Drug: A-623
    High dose given subcutaneously once every 4 weeks for up to 52 weeks
  • Other: Placebo Comparator
    Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks
Study Arms  ICMJE
  • Experimental: A-623 high dose weekly
    Intervention: Drug: A-623
  • Experimental: A-623 low dose weekly
    Intervention: Drug: A-623
  • Experimental: A-623 high dose every 4 weeks
    Intervention: Drug: A-623
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo Comparator
Publications * Furie RA, Leon G, Thomas M, Petri MA, Chu AD, Hislop C, Martin RS, Scheinberg MA; PEARL-SC Study. A phase 2, randomised, placebo-controlled clinical trial of blisibimod, an inhibitor of B cell activating factor, in patients with moderate-to-severe systemic lupus erythematosus, the PEARL-SC study. Ann Rheum Dis. 2015 Sep;74(9):1667-75. doi: 10.1136/annrheumdis-2013-205144. Epub 2014 Apr 19.

*   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: December 13, 2012)
547
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2010)
600
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of SLE by American College of Rheumatology guidelines.
  • On stable SLE treatment
  • Active SLE disease
  • Serologically active
  • 18 years of age or older
  • Receiving stable doses of prednisone between 7.5 mg and 40 mg per day

Exclusion Criteria:

  • Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
  • Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C.
  • Liver disease.
  • Anemia, neutropenia, or thrombocytopenia.
  • Malignancy within past 5 years
  • Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections.
  • History of active tuberculosis or a history of tuberculosis infection.
  • Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months.
  • Prior administration of any B cell depleting therapy in the past 18 months.
  • Pregnant or nursing
  • History of congenital immunodeficiency
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 NCT01162681
Other Study ID Numbers  ICMJE AN-SLE3321
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 January 2014

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