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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: A-623 Other: Placebo Comparator Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 547 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
Study Start Date : July 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: A-623 high dose weekly Drug: A-623
High dose given subcutaneously once a week for up to 52 weeks
Experimental: A-623 low dose weekly Drug: A-623
Low dose given subcutaneously once a week for up to 52 weeks
Experimental: A-623 high dose every 4 weeks Drug: A-623
High dose given subcutaneously once every 4 weeks for up to 52 weeks
Placebo Comparator: Placebo Other: Placebo Comparator
Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks


Outcome Measures
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Primary Outcome Measures :
  1. SLE response [ Time Frame: Various timepoints through Week 52 ]
    The % of subjects with SLE response compared with baseline at the time of assessment


Secondary Outcome Measures :
  1. B cell reduction [ Time Frame: Various timepoints through Week 52 ]
  2. Time to first flare [ Time Frame: Various timepoints through Week 52 ]
  3. FACIT-fatigue score [ Time Frame: Various timepoints through Week 52 ]
  4. Reduction in prednisone dose [ Time Frame: Various timepoints through Week 52 ]
  5. Change in IgG, IgM,C3 and C4 [ Time Frame: Various timepoints through Week 52 ]
  6. Flare rates [ Time Frame: Various timepoints through Week 52 ]
  7. SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9 [ Time Frame: Various timepoints through Week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162681


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Sponsors and Collaborators
Anthera Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01162681     History of Changes
Other Study ID Numbers: AN-SLE3321
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: January 2014
Keywords provided by Anthera Pharmaceuticals:
SLE
Lupus
Lupus Erythematosus, Systemic
 Autoimmune Diseases
A-623
Blisibimod
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases