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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)
This study has been completed.
Sponsor:
Anthera Pharmaceuticals
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01162681
First received: July 13, 2010
Last updated: January 30, 2014
Last verified: January 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Systemic Lupus Erythematosus | Drug: A-623 Other: Placebo Comparator | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
systemic lupus erythematosus
MedlinePlus related topics:
Lupus
U.S. FDA Resources
Further study details as provided by Anthera Pharmaceuticals:
Primary Outcome Measures:
- 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:
- 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 ]
| Enrollment: | 547 |
| Study Start Date: | July 2010 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01162681
Show 74 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162681
Show 74 Study Locations
Sponsors and Collaborators
Anthera Pharmaceuticals
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Anthera Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01162681 History of Changes |
| Other Study ID Numbers: |
AN-SLE3321 |
| Study First Received: | July 13, 2010 |
| Last Updated: | January 30, 2014 |
Keywords provided by Anthera Pharmaceuticals:
|
SLE Lupus Lupus Erythematosus, Systemic |
Autoimmune Diseases A-623 Blisibimod |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on August 16, 2017