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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305746
• Other study ID #: AN-SLE3322
• Status: Completed
• Phase: Phase 2
• First received: February 25, 2011
• Last updated: February 11, 2014
• Start date: April 2011
• Est. completion date: October 2013

Study information

• Verified date: February 2014
• Source: Anthera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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
• A-623
Low 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 given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Anthera Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Chile,  Colombia,  Hong Kong,  India,  Mexico,  Peru,  Philippines,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No