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

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
A-623
A-623
A-623
Sponsored by
Anthera Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE, Lupus, Lupus Erythematosus, Systemic, A-623, Autoimmune Diseases, Blisibimod

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator Site 103
  • Investigator Site 113
  • Investigator Site 110
  • Investigator Site 105
  • Investigator Site 102
  • Investigator Site 117
  • Investigator Site 104
  • Investigator Site 106
  • Investigator Site 114
  • Investigator Site 101
  • Investigator Site 112
  • Investigator Site 111
  • Investigator Site 115
  • Investigator Site 404
  • Investigator Site 402
  • Investigator Site 407
  • Investigator Site 401
  • Investigator Site 403
  • Investigator Site 406
  • Investigator Site 408
  • Investigator Site 504
  • Investigator Site 509
  • Investigator Site 507
  • Investigator Site 506
  • Investigator Site 503
  • Investigator Site 502
  • Investigator Site 501
  • Investigator Site 511
  • Investigator 505
  • Investigator Site 510
  • Investigator Site 606
  • Investigator Site 602
  • Investigator Site 605
  • Investigator Site 601
  • Investigator Site 706
  • Investigator Site 708
  • Investigator Site 710
  • Investigator Site 701
  • Investigator Site 704
  • Investigator Site 705
  • Investigator Site 702
  • Investigator Site 709
  • Investigator Site 707
  • Investigator Site 711
  • Investigator Site 153
  • Investigator Site 151
  • Investigator Site 205
  • Investigator Site 203
  • Investigator Site 204
  • Investigator Site 201
  • Investigator Site 809
  • Investigator Site 805
  • Investigator Site 807
  • Investigator Site 803
  • Investigator Site 802
  • Investigator Site 808
  • Investigator Site 806
  • Investigator Site 804
  • Investigator Site 801
  • Investigator Site 901
  • Investigator Site 902
  • Investigator Site 903
  • Investigator Site 904
  • Investigator Site 905
  • Investigator Site 302
  • Investigator Site 303
  • Investigator Site 305
  • Investigator Site 304
  • Investigator Site 352
  • Investigator Site 351
  • Investigator Site 354

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

A-623 high dose weekly

A-623 low dose weekly

A-623 high dose every 4 weeks

Arm Description

High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 25, 2011
Last Updated
February 11, 2014
Sponsor
Anthera Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01305746
Brief Title
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anthera Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
SLE, Lupus, Lupus Erythematosus, Systemic, A-623, Autoimmune Diseases, Blisibimod

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
382 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-623 high dose weekly
Arm Type
Experimental
Arm Description
High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
Arm Title
A-623 low dose weekly
Arm Type
Experimental
Arm Description
Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
Arm Title
A-623 high dose every 4 weeks
Arm Type
Experimental
Arm Description
High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
Intervention Type
Drug
Intervention Name(s)
A-623
Intervention Description
High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
Intervention Type
Drug
Intervention Name(s)
A-623
Intervention Description
Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
Intervention Type
Drug
Intervention Name(s)
A-623
Intervention Description
High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
Primary Outcome Measure Information:
Title
To assess the long term safety of A-623 in subjects with SLE
Description
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
Time Frame
Until the drug is approved or the Sponsor discontinues the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Investigator Site 103
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Investigator Site 113
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Investigator Site 110
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Investigator Site 105
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Investigator Site 102
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Investigator Site 117
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Investigator Site 104
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Investigator Site 106
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Investigator Site 114
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
Facility Name
Investigator Site 101
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Investigator Site 112
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Investigator Site 111
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Investigator Site 115
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Investigator Site 404
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Investigator Site 402
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Investigator Site 407
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425DTG
Country
Argentina
Facility Name
Investigator Site 401
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Investigator Site 403
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000PBJ
Country
Argentina
Facility Name
Investigator Site 406
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Investigator Site 408
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
Investigator Site 504
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40050-010
Country
Brazil
Facility Name
Investigator Site 509
City
Goias
State/Province
Goiania
ZIP/Postal Code
74605-050
Country
Brazil
Facility Name
Investigator Site 507
City
Goiania
State/Province
GO
ZIP/Postal Code
74110120
Country
Brazil
Facility Name
Investigator Site 506
City
Juiz de Fora
State/Province
MG
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
Investigator Site 503
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Investigator Site 502
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
9061-0000
Country
Brazil
Facility Name
Investigator Site 501
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
Investigator Site 511
City
Rio de Janeiro
ZIP/Postal Code
20551-030
Country
Brazil
Facility Name
Investigator 505
City
Sao Paulo
ZIP/Postal Code
04038-004
Country
Brazil
Facility Name
Investigator Site 510
City
Sao Paulo
ZIP/Postal Code
13015-001
Country
Brazil
Facility Name
Investigator Site 606
City
Santiago
State/Province
RM
ZIP/Postal Code
7510186
Country
Chile
Facility Name
Investigator Site 602
City
Santiago de Chile
ZIP/Postal Code
8330033
Country
Chile
Facility Name
Investigator Site 605
City
Santiago
Country
Chile
Facility Name
Investigator Site 601
City
Vina del Mar
ZIP/Postal Code
2570017
Country
Chile
Facility Name
Investigator Site 706
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Investigator Site 708
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Investigator Site 710
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Investigator Site 701
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Investigator Site 704
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Investigator Site 705
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
01
Country
Colombia
Facility Name
Investigator Site 702
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Investigator Site 709
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Investigator Site 707
City
Bucaramanga
State/Province
Santander
Country
Colombia
Facility Name
Investigator Site 711
City
Bucaramanga
State/Province
Santander
Country
Colombia
Facility Name
Investigator Site 153
City
New Territories
State/Province
Shatin
Country
Hong Kong
Facility Name
Investigator Site 151
City
Hong KoNG
Country
Hong Kong
Facility Name
Investigator Site 205
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 003
Country
India
Facility Name
Investigator Site 203
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Investigator Site 204
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Facility Name
Investigator Site 201
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Investigator Site 809
City
Mexico City
State/Province
C.p.
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Investigator Site 805
City
Mexico
State/Province
D.f.
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Investigator Site 807
City
Mexico
State/Province
D.f.
ZIP/Postal Code
6726
Country
Mexico
Facility Name
Investigator Site 803
City
Mexico City
State/Province
DF
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Investigator Site 802
City
Toluca
State/Province
Estado de Mexico
ZIP/Postal Code
50120
Country
Mexico
Facility Name
Investigator Site 808
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37320
Country
Mexico
Facility Name
Investigator Site 806
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Investigator Site 804
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58070
Country
Mexico
Facility Name
Investigator Site 801
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Investigator Site 901
City
Arequipa
Country
Peru
Facility Name
Investigator Site 902
City
Callao
Country
Peru
Facility Name
Investigator Site 903
City
Lima
ZIP/Postal Code
L-01
Country
Peru
Facility Name
Investigator Site 904
City
Lima
ZIP/Postal Code
L-01
Country
Peru
Facility Name
Investigator Site 905
City
Lima
Country
Peru
Facility Name
Investigator Site 302
City
Cebu City
State/Province
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Investigator Site 303
City
Davao City
State/Province
Davao
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Investigator Site 305
City
Davao City
State/Province
Davao
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Investigator Site 304
City
Manila City
State/Province
Metro Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
Investigator Site 352
City
Taiwan
State/Province
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Investigator Site 351
City
Taiwan
State/Province
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Investigator Site 354
City
Taichung
ZIP/Postal Code
402
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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