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

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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	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	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