A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321
An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)
1 other identifier
interventional
382
11 countries
71
Brief Summary
The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2011
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2011
CompletedFirst Posted
Study publicly available on registry
March 1, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFebruary 13, 2014
February 1, 2014
2.3 years
February 25, 2011
February 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the long term safety of A-623 in subjects with SLE
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
Until the drug is approved or the Sponsor discontinues the study
Study Arms (3)
A-623 high dose weekly
EXPERIMENTALHigh 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
EXPERIMENTALLow 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
EXPERIMENTALHigh dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
Interventions
High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
Eligibility Criteria
You may qualify if:
- Completed the treatment period specified in study AN-SLE3321 or were enrolled in study AN-SLE3321 prior to November 30, 2010
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Investigator Site 103
Birmingham, Alabama, 35294, United States
Investigator Site 113
Long Beach, California, 90806, United States
Investigator Site 110
Upland, California, 91786, United States
Investigator Site 105
Orlando, Florida, 32806, United States
Investigator Site 102
Tampa, Florida, 33614, United States
Investigator Site 117
Baltimore, Maryland, 21205, United States
Investigator Site 104
Lansing, Michigan, 48910, United States
Investigator Site 106
Lake Success, New York, 11042, United States
Investigator Site 114
Smithtown, New York, 11787, United States
Investigator Site 101
Greenville, North Carolina, 27834, United States
Investigator Site 112
Oklahoma City, Oklahoma, 73104, United States
Investigator Site 111
Tulsa, Oklahoma, 74104, United States
Investigator Site 115
Houston, Texas, 77034, United States
Investigator Site 404
Caba, Buenos Aires, C1015ABO, Argentina
Investigator Site 402
Caba, Buenos Aires, C1280AEB, Argentina
Investigator Site 407
Caba, Buenos Aires, C1425DTG, Argentina
Investigator Site 401
Caba, Buenos Aires, C1431FWO, Argentina
Investigator Site 408
San Juan, San Juan Province, 5400, Argentina
Investigator Site 403
Rosario, Santa Fe Province, S2000PBJ, Argentina
Investigator Site 406
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
Investigator Site 504
Salvador, Estado de Bahia, 40050-010, Brazil
Investigator Site 509
Goiás, Goiania, 74605-050, Brazil
Investigator Site 507
Goiânia, Goiás, 74110120, Brazil
Investigator Site 506
Juiz de Fora, Minas Gerais, 36010-570, Brazil
Investigator Site 511
Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil
Investigator Site 503
Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil
Investigator Site 502
Porto Alegre, Rio Grande do Sul, 9061-0000, Brazil
Investigator 505
São Paulo, São Paulo, 04038-004, Brazil
Investigator Site 501
São Paulo, São Paulo, 04039-901, Brazil
Investigator Site 510
São Paulo, 13015-001, Brazil
Investigator Site 606
Santiago, RM, 7510186, Chile
Investigator Site 605
Santiago, Santiago Metropolitan, Chile
Investigator Site 602
Santiago, 8330033, Chile
Investigator Site 601
Viña del Mar, 2570017, 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, 01, 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, 500 003, India
Investigator Site 203
Bangalore, Karnataka, 560034, India
Investigator Site 204
Trivandrum, Kerala, 695011, India
Investigator Site 201
Mumbai, Maharashtra, 400012, India
Investigator Site 809
Mexico City, C.p., 14000, Mexico
Investigator Site 805
México, D.f., 07760, Mexico
Investigator Site 807
México, D.f., 6726, Mexico
Investigator Site 808
León, Guanajuato, 37320, Mexico
Investigator Site 806
Guadalajara, Jalisco, 44280, Mexico
Investigator Site 803
Mexico City, Mexico City, 06726, Mexico
Investigator Site 804
Morelia, Michoacán, 58070, Mexico
Investigator Site 801
San Luis Potosí City, San Luis Potosí, 78240, Mexico
Investigator Site 802
Toluca, State of Mexico, 50120, Mexico
Investigator Site 903
Lima, Lima Province, L-01, Peru
Investigator Site 904
Lima, Lima Province, L-01, Peru
Investigator Site 905
Lima, Lima Province, Peru
Investigator Site 901
Arequipa, Peru
Investigator Site 902
Callao, Peru
Investigator Site 302
Cebu City, Cebu, 6000, Philippines
Investigator Site 303
Davao City, Davao Region, 8000, Philippines
Investigator Site 305
Davao City, Davao Region, 8000, Philippines
Investigator Site 304
Manila, National Capital Region, 1008, Philippines
Investigator Site 352
Dawan, Taichung, 404, Taiwan
Investigator Site 351
Taiwan, Taipei, 100, Taiwan
Investigator Site 354
Taichung, 402, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2011
First Posted
March 1, 2011
Study Start
April 1, 2011
Primary Completion
July 1, 2013
Study Completion
October 1, 2013
Last Updated
February 13, 2014
Record last verified: 2014-02