A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Drug: A-623
- Registration Number
- NCT01305746
- Lead Sponsor
- Anthera Pharmaceuticals
- Brief Summary
The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 382
- Completed the treatment period specified in study AN-SLE3321 or were enrolled in study AN-SLE3321 prior to November 30, 2010
- Developed a new medical disease or condition that has made the subject unsuitable for this study in the opinion of the Investigator, including interference with written informed consent, study evaluation, completion, and/or procedures
- Pregnant or nursing
- Any prior administration of a B-cell modulating therapy other than A-623
- Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to listed wash-out periods
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A-623 high dose weekly A-623 High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study A-623 low dose weekly A-623 Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study A-623 high dose every 4 weeks A-623 High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
- Primary Outcome Measures
Name Time Method To assess the long term safety of A-623 in subjects with SLE Until the drug is approved or the Sponsor discontinues the study Safety assessments such as AEs, SAEs, vital signs, ECG, clinical chemistry, hematology, and immunogenicity will be analyzed in a descriptive manner and will include infections, malignancies, injection site reactions and immunogenicity, neuropsychiatric events, and deaths
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (71)
Investigator Site 504
🇧🇷Salvador, Bahia, Brazil
Investigator Site 510
🇧🇷Sao Paulo, Brazil
Investigator Site 106
🇺🇸Lake Success, New York, United States
Investigator Site 104
🇺🇸Lansing, Michigan, United States
Investigator Site 110
🇺🇸Upland, California, United States
Investigator Site 114
🇺🇸Smithtown, New York, United States
Investigator Site 111
🇺🇸Tulsa, Oklahoma, United States
Investigator Site 117
🇺🇸Baltimore, Maryland, United States
Investigator Site 101
🇺🇸Greenville, North Carolina, United States
Investigator Site 501
🇧🇷Sao Paulo, SP, Brazil
Investigator Site 511
🇧🇷Rio de Janeiro, Brazil
Investigator Site 507
🇧🇷Goiania, GO, Brazil
Investigator Site 506
🇧🇷Juiz de Fora, MG, Brazil
Investigator Site 113
🇺🇸Long Beach, California, United States
Investigator Site 403
🇦🇷Rosario, Santa Fe, Argentina
Investigator Site 408
🇦🇷San Juan, Argentina
Investigator Site 406
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
Investigator 505
🇧🇷Sao Paulo, Brazil
Investigator Site 509
🇧🇷Goias, Goiania, Brazil
Investigator Site 503
🇧🇷Rio de Janeiro, RJ, Brazil
Investigator Site 502
🇧🇷Porto Alegre, RS, Brazil
Investigator Site 605
🇨🇱Santiago, Chile
Investigator Site 710
🇨🇴Medellin, Antioquia, Colombia
Investigator Site 702
🇨🇴Bogota, Cundinamarca, Colombia
Investigator Site 701
🇨🇴Barranquilla, Atlantico, Colombia
Investigator Site 705
🇨🇴Bogota, Cundinamarca, Colombia
Investigator Site 709
🇨🇴Bogota, Cundinamarca, Colombia
Investigator Site 201
🇮🇳Mumbai, Maharashtra, India
Investigator Site 711
🇨🇴Bucaramanga, Santander, Colombia
Investigator Site 707
🇨🇴Bucaramanga, Santander, Colombia
Investigator Site 203
🇮🇳Bangalore, Karnataka, India
Investigator Site 809
🇲🇽Mexico City, C.p., Mexico
Investigator Site 805
🇲🇽Mexico, D.f., Mexico
Investigator Site 803
🇲🇽Mexico City, DF, Mexico
Investigator Site 807
🇲🇽Mexico, D.f., Mexico
Investigator Site 802
🇲🇽Toluca, Estado de Mexico, Mexico
Investigator Site 808
🇲🇽Leon, Guanajuato, Mexico
Investigator Site 804
🇲🇽Morelia, Michoacan, Mexico
Investigator Site 902
🇵🇪Callao, Peru
Investigator Site 801
🇲🇽San Luis Potosi, Mexico
Investigator Site 806
🇲🇽Guadalajara, Jalisco, Mexico
Investigator Site 901
🇵🇪Arequipa, Peru
Investigator Site 903
🇵🇪Lima, Peru
Investigator Site 904
🇵🇪Lima, Peru
Investigator Site 905
🇵🇪Lima, Peru
Investigator Site 303
🇵ðŸ‡Davao City, Davao, Philippines
Investigator Site 304
🇵ðŸ‡Manila City, Metro Manila, Philippines
Investigator Site 401
🇦🇷Caba, Buenos Aires, Argentina
Investigator Site 606
🇨🇱Santiago, RM, Chile
Investigator Site 601
🇨🇱Vina del Mar, Chile
Investigator Site 404
🇦🇷Caba, Buenos Aires, Argentina
Investigator Site 204
🇮🇳Trivandrum, Kerala, India
Investigator Site 305
🇵ðŸ‡Davao City, Davao, Philippines
Investigator Site 354
🇨🇳Taichung, Taiwan
Investigator Site 352
🇨🇳Taiwan, Taichung, Taiwan
Investigator Site 602
🇨🇱Santiago de Chile, Chile
Investigator Site 706
🇨🇴Medellin, Antioquia, Colombia
Investigator Site 708
🇨🇴Medellin, Antioquia, Colombia
Investigator Site 205
🇮🇳Hyderabad, Andhra Pradesh, India
Investigator Site 302
🇵ðŸ‡Cebu City, Cebu, Philippines
Investigator Site 351
🇨🇳Taiwan, Taipei, Taiwan
Investigator Site 402
🇦🇷Caba, Buenos Aires, Argentina
Investigator Site 407
🇦🇷Caba, Buenos Aires, Argentina
Investigator Site 704
🇨🇴Barranquilla, Atlantico, Colombia
Investigator Site 103
🇺🇸Birmingham, Alabama, United States
Investigator Site 105
🇺🇸Orlando, Florida, United States
Investigator Site 102
🇺🇸Tampa, Florida, United States
Investigator Site 112
🇺🇸Oklahoma City, Oklahoma, United States
Investigator Site 115
🇺🇸Houston, Texas, United States
Investigator Site 153
ðŸ‡ðŸ‡°New Territories, Shatin, Hong Kong
Investigator Site 151
ðŸ‡ðŸ‡°Hong KoNG, Hong Kong