A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01305746
First received: February 25, 2011
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: A-623
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)

Resource links provided by NLM:


Further study details as provided by Anthera Pharmaceuticals:

Primary Outcome Measures:
  • To assess the long term safety of A-623 in subjects with SLE [ Time Frame: Until the drug is approved or the Sponsor discontinues the study ] [ Designated as safety issue: No ]
    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


Enrollment: 382
Study Start Date: April 2011
Study Completion Date: October 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: A-623
High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
Experimental: 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
Drug: A-623
Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
Experimental: 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
Drug: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305746

  Hide Study Locations
Locations
United States, Alabama
Investigator Site 103
Birmingham, Alabama, United States, 35294
United States, California
Investigator Site 113
Long Beach, California, United States, 90806
Investigator Site 110
Upland, California, United States, 91786
United States, Florida
Investigator Site 105
Orlando, Florida, United States, 32806
Investigator Site 102
Tampa, Florida, United States, 33614
United States, Maryland
Investigator Site 117
Baltimore, Maryland, United States, 21205
United States, Michigan
Investigator Site 104
Lansing, Michigan, United States, 48910
United States, New York
Investigator Site 106
Lake Success, New York, United States, 11042
Investigator Site 114
Smithtown, New York, United States, 11787
United States, North Carolina
Investigator Site 101
Greenville, North Carolina, United States, 27834
United States, Oklahoma
Investigator Site 112
Oklahoma City, Oklahoma, United States, 73104
Investigator Site 111
Tulsa, Oklahoma, United States, 74104
United States, Texas
Investigator Site 115
Houston, Texas, United States, 77034
Argentina
Investigator Site 401
Caba, Buenos Aires, Argentina, C1431FWO
Investigator Site 404
Caba, Buenos Aires, Argentina, C1015ABO
Investigator Site 407
Caba, Buenos Aires, Argentina, C1425DTG
Investigator Site 402
Caba, Buenos Aires, Argentina, C1280AEB
Investigator Site 403
Rosario, Santa Fe, Argentina, S2000PBJ
Investigator Site 406
San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
Investigator Site 408
San Juan, Argentina, 5400
Brazil
Investigator Site 504
Salvador, Bahia, Brazil, 40050-010
Investigator Site 509
Goias, Goiania, Brazil, 74605-050
Investigator Site 507
Goiania, GO, Brazil, 74110120
Investigator Site 506
Juiz de Fora, MG, Brazil, 36010-570
Investigator Site 503
Rio de Janeiro, RJ, Brazil, 21941-913
Investigator Site 502
Porto Alegre, RS, Brazil, 9061-0000
Investigator Site 501
Sao Paulo, SP, Brazil, 04039-901
Investigator Site 511
Rio de Janeiro, Brazil, 20551-030
Investigator Site 510
Sao Paulo, Brazil, 13015-001
Investigator 505
Sao Paulo, Brazil, 04038-004
Chile
Investigator Site 606
Santiago, RM, Chile, 7510186
Investigator Site 605
Santiago, Chile
Investigator Site 602
Santiago de Chile, Chile, 8330033
Investigator Site 601
Vina del Mar, Chile, 2570017
Colombia
Investigator Site 706
Medellin, Antioquia, Colombia
Investigator Site 710
Medellin, Antioquia, Colombia
Investigator Site 708
Medellin, Antioquia, Colombia
Investigator Site 701
Barranquilla, Atlantico, Colombia
Investigator Site 704
Barranquilla, Atlantico, Colombia
Investigator Site 702
Bogota, Cundinamarca, Colombia
Investigator Site 705
Bogota, Cundinamarca, Colombia, 01
Investigator Site 709
Bogota, Cundinamarca, Colombia
Investigator Site 707
Bucaramanga, Santander, Colombia
Investigator Site 711
Bucaramanga, Santander, Colombia
Hong Kong
Investigator Site 153
New Territories, Shatin, Hong Kong
Investigator Site 151
Hong KoNG, Hong Kong
India
Investigator Site 205
Hyderabad, Andhra Pradesh, India, 500 003
Investigator Site 203
Bangalore, Karnataka, India, 560034
Investigator Site 204
Trivandrum, Kerala, India, 695011
Investigator Site 201
Mumbai, Maharashtra, India, 400012
Mexico
Investigator Site 809
Mexico City, C.p., Mexico, 14000
Investigator Site 807
Mexico, D.f., Mexico, 6726
Investigator Site 805
Mexico, D.f., Mexico, 07760
Investigator Site 803
Mexico City, DF, Mexico, 06726
Investigator Site 802
Toluca, Estado de Mexico, Mexico, 50120
Investigator Site 808
Leon, Guanajuato, Mexico, 37320
Investigator Site 806
Guadalajara, Jalisco, Mexico, 44280
Investigator Site 804
Morelia, Michoacan, Mexico, 58070
Investigator Site 801
San Luis Potosi, Mexico, 78240
Peru
Investigator Site 901
Arequipa, Peru
Investigator Site 902
Callao, Peru
Investigator Site 905
Lima, Peru
Investigator Site 904
Lima, Peru, L-01
Investigator Site 903
Lima, Peru, L-01
Philippines
Investigator Site 302
Cebu City, Cebu, Philippines, 6000
Investigator Site 303
Davao City, Davao, Philippines, 8000
Investigator Site 305
Davao City, Davao, Philippines, 8000
Investigator Site 304
Manila City, Metro Manila, Philippines, 1008
Taiwan
Investigator Site 352
Taiwan, Taichung, Taiwan, 404
Investigator Site 351
Taiwan, Taipei, Taiwan, 100
Investigator Site 354
Taichung, Taiwan, 402
Sponsors and Collaborators
Anthera Pharmaceuticals
  More Information

No publications provided

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01305746     History of Changes
Other Study ID Numbers: AN-SLE3322
Study First Received: February 25, 2011
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Anthera Pharmaceuticals:
SLE
Lupus
Lupus Erythematosus, Systemic
A-623
Autoimmune Diseases
Blisibimod

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 01, 2014