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
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Sponsor:
Anthera Pharmaceuticals
Information provided by (Responsible Party):
Anthera Pharmaceuticals
Tracking Information | |||
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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 |
SLE response [ Time Frame: Various timepoints through Week 52 ] The % of subjects with SLE response compared with baseline at the time of assessment
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE | Systemic Lupus Erythematosus | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
547 | ||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | ||
Current Responsible Party | Anthera Pharmaceuticals | ||
Original Responsible Party | Anthera Pharmaceuticals, Inc, Georgina Kilfoil | ||
Current Study Sponsor ICMJE | Anthera Pharmaceuticals | ||
Original Study Sponsor ICMJE | Same as current | ||
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 |