PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Drug: A-623Other: Placebo Comparator
- Registration Number
- NCT01162681
- Lead Sponsor
- Anthera Pharmaceuticals
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 547
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A-623 high dose every 4 weeks A-623 - Placebo Placebo Comparator - A-623 high dose weekly A-623 - A-623 low dose weekly A-623 -
- Primary Outcome Measures
Name Time Method SLE response Various timepoints through Week 52 The % of subjects with SLE response compared with baseline at the time of assessment
- Secondary Outcome Measures
Name Time Method Reduction in prednisone dose Various timepoints through Week 52 Time to first flare Various timepoints through Week 52 SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9 Various timepoints through Week 52 B cell reduction Various timepoints through Week 52 FACIT-fatigue score Various timepoints through Week 52 Change in IgG, IgM,C3 and C4 Various timepoints through Week 52 Flare rates Various timepoints through Week 52
Trial Locations
- Locations (74)
Investigator Site 108
🇺🇸Los Angeles, California, United States
Investigator Site 111
🇺🇸Tulsa, Oklahoma, United States
Investigator Site 114
🇺🇸Smithtown, New York, United States
Investigator Site 110
🇺🇸Upland, California, United States
Investigator Site 502
🇧🇷Porto Alegre, RS, Brazil
Investigator Site 113
🇺🇸Long Beach, California, United States
Investigator Site 505
🇧🇷Sao Paulo, Brazil
Investigator Site 511
🇧🇷Rio de Janeiro, Brazil
Investigator Site 351
🇨🇳Taipei, Taiwan
Investigator Site 501
🇧🇷Sao Paulo, SP, Brazil
Investigator Site 706
🇨🇴Medellin, Antioquia, Colombia
Investigator Site 701
🇨🇴Barranquilla, Atlantico, Colombia
Investigator Site 117
🇺🇸Baltimore, Maryland, United States
Investigator Site 106
🇺🇸Lake Success, New York, United States
Investigator Site 101
🇺🇸Greenville, North Carolina, United States
Investigator Site 404
🇦🇷Caba, Buenos Aires, Argentina
Investigator Site 402
🇦🇷Caba, Buenos Aires, Argentina
Investigator Site 403
🇦🇷Rosario, Santa Fe, Argentina
Investigator Site 406
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
Investigator Site 407
🇦🇷Buenos Aires, Argentina
Investigator Site 408
🇦🇷San Juan, Argentina
Investigator Site 401
🇦🇷Buenos Aires, Argentina
Investigator Site 509
🇧🇷Goias, Goiania, Brazil
Investigator Site 506
🇧🇷Juiz de Fora, MG, Brazil
Investigator Site 512
🇧🇷Porto Alegre, Rio de Grande do Sul, Brazil
Investigator Site 503
🇧🇷Rio de Janeiro, RJ, Brazil
Investigator Site 302
🇵🇭Cebu, Philippines
Investigator Site 504
🇧🇷Salvador, Bahia, Brazil
Investigator Site 702
🇨🇴Bogota, Colombia
Investigator Site 705
🇨🇴Bogota, Colombia
Investigator Site 902
🇵🇪Bellavista Callao, Callao, Peru
Investigator Site 352
🇨🇳Taichung, Taiwan
Investigator Site 151
🇭🇰Hong Kong, Hong Kong
Investigator Site 203
🇮🇳Bangalore, Kamataka, India
Investigator Site 802
🇲🇽Toluca, Estado de Mexico, Mexico
Investigator Site 901
🇵🇪Cayma, Arequipa, Peru
Investigator Site 903
🇵🇪Lima, Peru
Investigator Site 905
🇵🇪Lima, Peru
Investigator Site 606
🇨🇱Santiago, Chile
Investigator Site 710
🇨🇴Medellin, Antioquia, Colombia
Investigator Site 711
🇨🇴Bucaramanga, Colombia
Investigator Site 708
🇨🇴Medellin, Colombia
Investigator Site 803
🇲🇽Mexico City, D.f., Mexico
Investigator Site 801
🇲🇽San Luis Potosi, Mexico
Investigator Site 303
🇵🇭Davao City, Davao, Philippines
Investigator Site 304
🇵🇭Manila City, Metro Manila, Philippines
Investigator Site 806
🇲🇽Guadalajara, Jalisco, Mexico
Investigator Site 605
🇨🇱Santiago, Chile
Inestigator Site 809
🇲🇽Mexico, D.f., Mexico
Investigator Site 904
🇵🇪Lima, Peru
Investigator Site 104
🇺🇸Lansing, Michigan, United States
Investigator Site 704
🇨🇴Barranquilla, Atlántico, Colombia
Investigator Site 703
🇨🇴Bogota, Cundinamarca, Colombia
Investigator Site 602
🇨🇱Santiago de Chile, Chile
Investigator Site 201
🇮🇳Mumbai, Maharashtra, India
Investigator Site 601
🇨🇱Vina del Mar, Chile
Investigator Site 709
🇨🇴Bogota, Colombia
Investigator Site 205
🇮🇳Secunderabad, Andhra Pradesh, India
Investigator Site 204
🇮🇳Trivandrum, Kerala, India
Investigator Site 804
🇲🇽Morelia, Michoacan, Mexico
Investigator Site 805
🇲🇽Mexico, Mexico
Investigator Site 807
🇲🇽Mexico, Mexico
Investigator Site 305
🇵🇭Davao, Philippines
Investigator Site 354
🇨🇳Taichung, Taiwan
Investigator Site 808
🇲🇽Guanajuato, Mexico
Investigator Site 707
🇨🇴Bucaramanga, Santander, Colombia
Investigator Site 103
🇺🇸Birmingham, Alabama, United States
Investigator Site 112
🇺🇸Oklahoma City, Oklahoma, United States
Investigator Site 115
🇺🇸Houston, Texas, United States
Investigator Site 507
🇧🇷Goiania, GO, Brazil
Investigator Site 510
🇧🇷Campinas, Sao Paulo, Brazil
Investigator Site 105
🇺🇸Orlando, Florida, United States
Investigator Site 102
🇺🇸Tampa, Florida, United States
Investigator Site 153
🇭🇰New Territories, Shatin, Hong Kong