A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321
NCT ID: NCT01305746
Last Updated: 2014-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
382 participants
INTERVENTIONAL
2011-04-30
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A-623 high dose weekly
High 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 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
Low 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 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
High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
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
Interventions
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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 given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Anthera Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Investigator Site 103
Birmingham, Alabama, United States
Investigator Site 113
Long Beach, California, United States
Investigator Site 110
Upland, California, United States
Investigator Site 105
Orlando, Florida, United States
Investigator Site 102
Tampa, Florida, United States
Investigator Site 117
Baltimore, Maryland, United States
Investigator Site 104
Lansing, Michigan, United States
Investigator Site 106
Lake Success, New York, United States
Investigator Site 114
Smithtown, New York, United States
Investigator Site 101
Greenville, North Carolina, United States
Investigator Site 112
Oklahoma City, Oklahoma, United States
Investigator Site 111
Tulsa, Oklahoma, United States
Investigator Site 115
Houston, Texas, United States
Investigator Site 404
Caba, Buenos Aires, Argentina
Investigator Site 402
Caba, Buenos Aires, Argentina
Investigator Site 407
Caba, Buenos Aires, Argentina
Investigator Site 401
Caba, Buenos Aires, Argentina
Investigator Site 408
San Juan, San Juan Province, Argentina
Investigator Site 403
Rosario, Santa Fe Province, Argentina
Investigator Site 406
San Miguel de Tucumán, Tucumán Province, Argentina
Investigator Site 504
Salvador, Estado de Bahia, Brazil
Investigator Site 509
Goiás, Goiania, Brazil
Investigator Site 507
Goiânia, Goiás, Brazil
Investigator Site 506
Juiz de Fora, Minas Gerais, Brazil
Investigator Site 511
Rio de Janeiro, Rio de Janeiro, Brazil
Investigator Site 503
Rio de Janeiro, Rio de Janeiro, Brazil
Investigator Site 502
Porto Alegre, Rio Grande do Sul, Brazil
Investigator 505
São Paulo, São Paulo, Brazil
Investigator Site 501
São Paulo, São Paulo, Brazil
Investigator Site 510
São Paulo, , Brazil
Investigator Site 606
Santiago, RM, Chile
Investigator Site 605
Santiago, Santiago Metropolitan, Chile
Investigator Site 602
Santiago, , Chile
Investigator Site 601
Viña del Mar, , Chile
Investigator Site 706
Medellín, Antioquia, Colombia
Investigator Site 708
Medellín, Antioquia, Colombia
Investigator Site 710
Medellín, Antioquia, Colombia
Investigator Site 701
Barranquilla, Atlántico, Colombia
Investigator Site 704
Barranquilla, Atlántico, Colombia
Investigator Site 705
Bogota, Cundinamarca, Colombia
Investigator Site 702
Bogota, Cundinamarca, Colombia
Investigator Site 709
Bogota, Cundinamarca, Colombia
Investigator Site 707
Bucaramanga, Santander Department, Colombia
Investigator Site 711
Bucaramanga, Santander Department, Colombia
Investigator Site 153
New Territories, Shatin, Hong Kong
Investigator Site 151
Hong Kong, , Hong Kong
Investigator Site 205
Hyderabad, Andhra Pradesh, India
Investigator Site 203
Bangalore, Karnataka, India
Investigator Site 204
Trivandrum, Kerala, India
Investigator Site 201
Mumbai, Maharashtra, India
Investigator Site 809
Mexico City, C.p., Mexico
Investigator Site 805
México, D.f., Mexico
Investigator Site 807
México, D.f., Mexico
Investigator Site 808
León, Guanajuato, Mexico
Investigator Site 806
Guadalajara, Jalisco, Mexico
Investigator Site 803
Mexico City, Mexico City, Mexico
Investigator Site 804
Morelia, Michoacán, Mexico
Investigator Site 801
San Luis Potosí City, San Luis Potosí, Mexico
Investigator Site 802
Toluca, State of Mexico, Mexico
Investigator Site 903
Lima, Lima Province, Peru
Investigator Site 904
Lima, Lima Province, Peru
Investigator Site 905
Lima, Lima Province, Peru
Investigator Site 901
Arequipa, , Peru
Investigator Site 902
Callao, , Peru
Investigator Site 302
Cebu City, Cebu, Philippines
Investigator Site 303
Davao City, Davao Region, Philippines
Investigator Site 305
Davao City, Davao Region, Philippines
Investigator Site 304
Manila, National Capital Region, Philippines
Investigator Site 352
Dawan, Taichung, Taiwan
Investigator Site 351
Taiwan, Taipei, Taiwan
Investigator Site 354
Taichung, , Taiwan
Countries
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Other Identifiers
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AN-SLE3322
Identifier Type: -
Identifier Source: org_study_id
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