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

February 11, 2014 updated by: Anthera Pharmaceuticals

An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

382

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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
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
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
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
High dose given subcutaneously once every 4 weeks 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 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthera Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

February 25, 2011

First Submitted That Met QC Criteria

February 28, 2011

First Posted (Estimate)

March 1, 2011

Study Record Updates

Last Update Posted (Estimate)

February 13, 2014

Last Update Submitted That Met QC Criteria

February 11, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-SLE3322

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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