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:
Anthera Pharmaceuticals
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
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:
Further study details as provided by Anthera Pharmaceuticals:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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 ]
| 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 |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162681
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| United States, Alabama | |
| Investigator Site 103 | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Investigator Site 113 | |
| Long Beach, California, United States, 90806 | |
| Investigator Site 108 | |
| Los Angeles, California, United States, 90095 | |
| Investigator Site 110 | |
| Upland, California, United States, 91786 | |
| United States, Florida | |
| Investigator Site 105 | |
| Orlando, Florida, United States, 32806 | |
| Investigator Site 102 | |
| Tampa, Florida, United States, 33614 | |
| United States, Maryland | |
| Investigator Site 117 | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Michigan | |
| Investigator Site 104 | |
| Lansing, Michigan, United States, 48910 | |
| United States, New York | |
| Investigator Site 106 | |
| Lake Success, New York, United States, 11042 | |
| Investigator Site 114 | |
| Smithtown, New York, United States, 11787 | |
| United States, North Carolina | |
| Investigator Site 101 | |
| Greenville, North Carolina, United States, 27834 | |
| United States, Oklahoma | |
| Investigator Site 112 | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Investigator Site 111 | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Texas | |
| Investigator Site 115 | |
| Houston, Texas, United States, 77034 | |
| Argentina | |
| Investigator Site 404 | |
| Caba, Buenos Aires, Argentina, C1015ABO | |
| Investigator Site 402 | |
| Caba, Buenos Aires, Argentina, C1280AEB | |
| Investigator Site 403 | |
| Rosario, Santa Fe, Argentina, S2000PBJ | |
| Investigator Site 406 | |
| San Miguel de Tucuman, Tucuman, Argentina, T4000AXL | |
| Investigator Site 401 | |
| Buenos Aires, Argentina, C1431FWO | |
| Investigator Site 407 | |
| Buenos Aires, Argentina, C1121ABE | |
| Investigator Site 408 | |
| San Juan, Argentina, 5400 | |
| Brazil | |
| Investigator Site 504 | |
| Salvador, Bahia, Brazil, 40050-010 | |
| Investigator Site 509 | |
| Goias, Goiania, Brazil, 74605-050 | |
| Investigator Site 507 | |
| Goiania, GO, Brazil, 74110120 | |
| Investigator Site 506 | |
| Juiz de Fora, MG, Brazil, 36010-570 | |
| Investigator Site 512 | |
| Porto Alegre, Rio de Grande do Sul, Brazil, 90035-903 | |
| Investigator Site 503 | |
| Rio de Janeiro, RJ, Brazil, 21941 | |
| Investigator Site 502 | |
| Porto Alegre, RS, Brazil, 9061-0000 | |
| Investigator Site 510 | |
| Campinas, Sao Paulo, Brazil, 13015 | |
| Investigator Site 501 | |
| Sao Paulo, SP, Brazil, 04039-901 | |
| Investigator Site 511 | |
| Rio de Janeiro, Brazil, 20551 | |
| Investigator Site 505 | |
| Sao Paulo, Brazil, 04038-004 | |
| Chile | |
| Investigator Site 606 | |
| Santiago, Chile | |
| Investigator Site 605 | |
| Santiago, Chile | |
| Investigator Site 602 | |
| Santiago de Chile, Chile, 8330033 | |
| Investigator Site 601 | |
| Vina del Mar, Chile, 2570017 | |
| Colombia | |
| Investigator Site 706 | |
| Medellin, Antioquia, Colombia | |
| Investigator Site 710 | |
| Medellin, Antioquia, Colombia | |
| Investigator Site 701 | |
| Barranquilla, Atlantico, Colombia | |
| Investigator Site 704 | |
| Barranquilla, Atlántico, Colombia | |
| Investigator Site 703 | |
| Bogota, Cundinamarca, Colombia | |
| Investigator Site 707 | |
| Bucaramanga, Santander, Colombia | |
| Investigator Site 709 | |
| Bogota, Colombia | |
| Investigator Site 702 | |
| Bogota, Colombia | |
| Investigator Site 705 | |
| Bogota, Colombia | |
| Investigator Site 711 | |
| Bucaramanga, Colombia | |
| Investigator Site 708 | |
| Medellin, Colombia | |
| Hong Kong | |
| Investigator Site 153 | |
| New Territories, Shatin, Hong Kong | |
| Investigator Site 151 | |
| Hong Kong, Hong Kong | |
| India | |
| Investigator Site 205 | |
| Secunderabad, Andhra Pradesh, India, 500003 | |
| Investigator Site 203 | |
| Bangalore, Kamataka, India, 560034 | |
| Investigator Site 204 | |
| Trivandrum, Kerala, India, 695011 | |
| Investigator Site 201 | |
| Mumbai, Maharashtra, India, 400012 | |
| Mexico | |
| Inestigator Site 809 | |
| Mexico, D.f., Mexico, 14000 | |
| Investigator Site 803 | |
| Mexico City, D.f., Mexico, 06726 | |
| Investigator Site 802 | |
| Toluca, Estado de Mexico, Mexico, 50120 | |
| Investigator Site 806 | |
| Guadalajara, Jalisco, Mexico, 44280 | |
| Investigator Site 804 | |
| Morelia, Michoacan, Mexico, 58070 | |
| Investigator Site 808 | |
| Guanajuato, Mexico | |
| Investigator Site 807 | |
| Mexico, Mexico | |
| Investigator Site 805 | |
| Mexico, Mexico | |
| Investigator Site 801 | |
| San Luis Potosi, Mexico, 78240 | |
| Peru | |
| Investigator Site 901 | |
| Cayma, Arequipa, Peru | |
| Investigator Site 902 | |
| Bellavista Callao, Callao, Peru | |
| Investigator Site 904 | |
| Lima, Peru | |
| Investigator Site 905 | |
| Lima, Peru, L27 | |
| Investigator Site 903 | |
| Lima, Peru, L-01 | |
| Philippines | |
| Investigator Site 303 | |
| Davao City, Davao, Philippines, 8000 | |
| Investigator Site 304 | |
| Manila City, Metro Manila, Philippines, 1008 | |
| Investigator Site 302 | |
| Cebu, Philippines, 6000 | |
| Investigator Site 305 | |
| Davao, Philippines, 8000 | |
| Taiwan | |
| Investigator Site 354 | |
| Taichung, Taiwan, 402 | |
| Investigator Site 352 | |
| Taichung, Taiwan, 414 | |
| Investigator Site 351 | |
| Taipei, Taiwan, 100 | |
Sponsors and Collaborators
Anthera Pharmaceuticals
More Information
No publications provided
| 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: | March 19, 2013 |
| Health Authority: | United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: National Health Surveillance Agency Chile: Instituto de Salud Publica de Chile Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos India: Drugs Controller General of India Mexico: Federal Commission for Protection Against Health Risks Peru: Instituto Nacional de Salud Philippines: Bureau of Food and Drugs |
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 May 19, 2013