Clinical trial NCT01305746: A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321
Official title: An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
Lupus
Lupus Erythematosus, Systemic
A-623
Autoimmune Diseases
Blisibimod
Lead sponsor: Anthera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-03-01
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.


Eligibility criteria: Inclusion Criteria:

* Completed the treatment period specified in study AN-SLE3321 or were enrolled in study AN-SLE3321 prior to November 30, 2010

Exclusion Criteria:

* 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

Primary outcomes:
measure: To assess the long term safety of A-623 in subjects with SLE
timeFrame: Until the drug is approved or the Sponsor discontinues the study
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigator Site 103
state: Alabama
city: Long Beach
country: United States
facility: Investigator Site 113
state: California
city: Upland
country: United States
facility: Investigator Site 110
state: California
city: Orlando
country: United States
facility: Investigator Site 105
state: Florida
city: Tampa
country: United States
facility: Investigator Site 102
state: Florida
city: Baltimore
country: United States
facility: Investigator Site 117
state: Maryland
city: Lansing
country: United States
facility: Investigator Site 104
state: Michigan
city: Lake Success
country: United States
facility: Investigator Site 106
state: New York
city: Smithtown
country: United States
facility: Investigator Site 114
state: New York
city: Greenville
country: United States
facility: Investigator Site 101
state: North Carolina
city: Oklahoma City
country: United States
facility: Investigator Site 112
state: Oklahoma
city: Tulsa
country: United States
facility: Investigator Site 111
state: Oklahoma
city: Houston
country: United States
facility: Investigator Site 115
state: Texas
city: Caba
country: Argentina
facility: Investigator Site 404
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigator Site 402
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigator Site 407
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigator Site 401
state: Buenos Aires
city: Rosario
country: Argentina
facility: Investigator Site 403
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Investigator Site 406
state: Tucuman
city: San Juan
country: Argentina
facility: Investigator Site 408
city: Salvador
country: Brazil
facility: Investigator Site 504
state: Bahia
city: Goias
country: Brazil
facility: Investigator Site 509
state: Goiania
city: Goiania
country: Brazil
facility: Investigator Site 507
state: GO
city: Juiz de Fora
country: Brazil
facility: Investigator Site 506
state: MG
city: Rio de Janeiro
country: Brazil
facility: Investigator Site 503
state: RJ
city: Porto Alegre
country: Brazil
facility: Investigator Site 502
state: RS
city: Sao Paulo
country: Brazil
facility: Investigator Site 501
state: SP
city: Rio de Janeiro
country: Brazil
facility: Investigator Site 511
city: Sao Paulo
country: Brazil
facility: Investigator 505
city: Sao Paulo
country: Brazil
facility: Investigator Site 510
city: Santiago
country: Chile
facility: Investigator Site 606
state: RM
city: Santiago de Chile
country: Chile
facility: Investigator Site 602
city: Santiago
country: Chile
facility: Investigator Site 605
city: Vina del Mar
country: Chile
facility: Investigator Site 601
city: Medellin
country: Colombia
facility: Investigator Site 706
state: Antioquia
city: Medellin
country: Colombia
facility: Investigator Site 708
state: Antioquia
city: Medellin
country: Colombia
facility: Investigator Site 710
state: Antioquia
city: Barranquilla
country: Colombia
facility: Investigator Site 701
state: Atlantico
city: Barranquilla
country: Colombia
facility: Investigator Site 704
state: Atlantico
city: Bogota
country: Colombia
facility: Investigator Site 705
state: Cundinamarca
city: Bogota
country: Colombia
facility: Investigator Site 702
state: Cundinamarca
city: Bogota
country: Colombia
facility: Investigator Site 709
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Investigator Site 707
state: Santander
city: Bucaramanga
country: Colombia
facility: Investigator Site 711
state: Santander
city: New Territories
country: Hong Kong
facility: Investigator Site 153
state: Shatin
city: Hong KoNG
country: Hong Kong
facility: Investigator Site 151
city: Hyderabad
country: India
facility: Investigator Site 205
state: Andhra Pradesh
city: Bangalore
country: India
facility: Investigator Site 203
state: Karnataka
city: Trivandrum
country: India
facility: Investigator Site 204
state: Kerala
city: Mumbai
country: India
facility: Investigator Site 201
state: Maharashtra
city: Mexico City
country: Mexico
facility: Investigator Site 809
state: C.p.
city: Mexico
country: Mexico
facility: Investigator Site 805
state: D.f.
city: Mexico
country: Mexico
facility: Investigator Site 807
state: D.f.
city: Mexico City
country: Mexico
facility: Investigator Site 803
state: DF
city: Toluca
country: Mexico
facility: Investigator Site 802
state: Estado de Mexico
city: Leon
country: Mexico
facility: Investigator Site 808
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Investigator Site 806
state: Jalisco
city: Morelia
country: Mexico
facility: Investigator Site 804
state: Michoacan
city: San Luis Potosi
country: Mexico
facility: Investigator Site 801
city: Arequipa
country: Peru
facility: Investigator Site 901
city: Callao
country: Peru
facility: Investigator Site 902
city: Lima
country: Peru
facility: Investigator Site 903
city: Lima
country: Peru
facility: Investigator Site 904
city: Lima
country: Peru
facility: Investigator Site 905
city: Cebu City
country: Philippines
facility: Investigator Site 302
state: Cebu
city: Davao City
country: Philippines
facility: Investigator Site 303
state: Davao
city: Davao City
country: Philippines
facility: Investigator Site 305
state: Davao
city: Manila City
country: Philippines
facility: Investigator Site 304
state: Metro Manila
city: Taiwan
country: Taiwan
facility: Investigator Site 352
state: Taichung
city: Taiwan
country: Taiwan
facility: Investigator Site 351
state: Taipei
city: Taichung
country: Taiwan
facility: Investigator Site 354
Study officials:
References: