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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Anthera Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01162681

First received: July 13, 2010

Last updated: March 19, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	July 13, 2010
Last Updated Date	March 19, 2013
Start Date ^ICMJE	July 2010
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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] Time to first flare [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ] FACIT-fatigue score [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ] Reduction in prednisone dose [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ] Change in IgG, IgM,C3 and C4 [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ] Flare rates [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ] SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9 [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: July 13, 2010)	B cell reduction [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] Time to first flare after randomization FACIT-fatigue score [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ] Change in FACIT score from baseline Reduction in prednisone dose [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 Arm (s)	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 *	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
Enrollment ^ICMJE	547
Completion Date	April 2012
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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Brazil, Chile, Colombia, Hong Kong, India, Mexico, Peru, Philippines, Taiwan

Administrative Information
NCT Number ^ICMJE	NCT01162681
Other Study ID Numbers ^ICMJE	AN-SLE3321
Has Data Monitoring Committee	Yes
Responsible Party	Anthera Pharmaceuticals
Study Sponsor ^ICMJE	Anthera Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Anthera Pharmaceuticals
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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