PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

PHASE2CompletedINTERVENTIONAL
Enrollment

547

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

April 30, 2012

Study Completion Date

April 30, 2012

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

A-623

High dose given subcutaneously once a week for up to 52 weeks

DRUG

A-623

Low dose given subcutaneously once a week for up to 52 weeks

DRUG

A-623

High dose given subcutaneously once every 4 weeks for up to 52 weeks

OTHER

Placebo Comparator

Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks

Trial Locations (74)

100

Investigator Site 351, Taipei

402

Investigator Site 354, Taichung

414

Investigator Site 352, Taichung

1008

Investigator Site 304, Manila

5400

Investigator Site 408, San Juan

6000

Investigator Site 302, Cebu

8000

Investigator Site 303, Davao City

Investigator Site 305, Davao City

11042

Investigator Site 106, Lake Success

11787

Investigator Site 114, Smithtown

13015

Investigator Site 510, Campinas

14000

Inestigator Site 809, México

20551

Investigator Site 511, Rio de Janeiro

21205

Investigator Site 117, Baltimore

21941

Investigator Site 503, Rio de Janeiro

27834

Investigator Site 101, Greenville

32806

Investigator Site 105, Orlando

33614

Investigator Site 102, Tampa

35294

Investigator Site 103, Birmingham

44280

Investigator Site 806, Guadalajara

48910

Investigator Site 104, Lansing

50120

Investigator Site 802, Toluca

58070

Investigator Site 804, Morelia

73104

Investigator Site 112, Oklahoma City

74104

Investigator Site 111, Tulsa

77034

Investigator Site 115, Houston

78240

Investigator Site 801, San Luis Potosí City

90095

Investigator Site 108, Los Angeles

90806

Investigator Site 113, Long Beach

91786

Investigator Site 110, Upland

400012

Investigator Site 201, Mumbai

500003

Investigator Site 205, Secunderabad

560034

Investigator Site 203, Bangalore

695011

Investigator Site 204, Trivandrum

2570017

Investigator Site 601, Viña del Mar

8330033

Investigator Site 602, Santiago

74110120

Investigator Site 507, Goiânia

C1015ABO

Investigator Site 404, Caba

C1280AEB

Investigator Site 402, Caba

S2000PBJ

Investigator Site 403, Rosario

T4000AXL

Investigator Site 406, San Miguel de Tucumán

C1121ABE

Investigator Site 407, Buenos Aires

C1431FWO

Investigator Site 401, Buenos Aires

40050-010

Investigator Site 504, Salvador

74605-050

Investigator Site 509, Goiás

36010-570

Investigator Site 506, Juiz de Fora

90035-903

Investigator Site 512, Porto Alegre

9061-0000

Investigator Site 502, Porto Alegre

04038-004

Investigator Site 505, São Paulo

04039-901

Investigator Site 501, São Paulo

Unknown

Investigator Site 606, Santiago

Investigator Site 605, Santiago

Investigator Site 706, Medellín

Investigator Site 710, Medellín

Investigator Site 701, Barranquilla

Investigator Site 704, Barranquilla

Investigator Site 703, Bogota

Investigator Site 707, Bucaramanga

Investigator Site 702, Bogotá

Investigator Site 705, Bogotá

Investigator Site 709, Bogotá

Investigator Site 711, Bucaramanga

Investigator Site 708, Medellín

Investigator Site 153, New Territories

Investigator Site 151, Hong Kong

Investigator Site 808, Guanajuato City

Investigator Site 805, México

Investigator Site 807, México

Investigator Site 901, Cayma

Investigator Site 904, Lima

Investigator Site 902, Bellavista Callao

06726

Investigator Site 803, Mexico City

L-01

Investigator Site 903, Lima

L27

Investigator Site 905, Lima

Sponsors
All Listed Sponsors
lead

Anthera Pharmaceuticals

INDUSTRY

NCT01162681 - PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus | Biotech Hunter | Biotech Hunter