A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057Estudio de continuación multicéntrico de belimumab (HGS1006, LymphoStat-B?), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) que completaron el protocolo de fase III HGS1006-C1056 o HGS1006-C1057

Phase 1

• Conditions: Systemic lupus erythematosus (SLE)Lupus Eritematoso Sistémico (LES); MedDRA version: 9.1Level: LLTClassification code 10042945Term: Systemic lupus erythematosus

• Registration Number: EUCTR2007-007648-85-ES
• Lead Sponsor: Human Genome Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-25
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1620

Inclusion Criteria

1.Have completed the HGS1006-C1056 or HGS1006-C1057 Protocol through the week 72 or week 48 visits, respectively.

2.Be able to receive the 1st dose of belimumab for HGS1006-C1074 four weeks (minimum of 2 weeks, maximum of 8 weeks) after the last dose in HGS1006-C1056 or HGS1006 C1057.

3.A female subject is eligible to enter the study if she is:
?not pregnant or nursing;
?of non-childbearing potential (ie, women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); or
?of childbearing potential (ie, women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative urine pregnancy test at Day 0, and agree to 1 of the following:
-complete abstinence from intercourse from the administration of the 1st dose of study agent until 8 weeks after the last dose of study agent; or
-consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the study agent and 8 weeks after the last dose of study agent:
?implants of levonorgestrel;
?injectable progesterone;
?any intrauterine device (IUD) with a documented failure rate of less than 1% per year;
?oral contraceptives (either combined or progesterone only);
?double barrier method: ie, condom, cervical cap or diaphragm with spermicidal agent;
?transdermal contraceptive patch;
?male partner who is sterile prior to the female subject?s entry into the study and is the sole sexual partner for the female subject.

4.A male subject is eligible to enter the study if he agrees to use effective contraception throughout the study and for 3 months after the last dose of study agent.

5.Have the ability to understand the requirements of the study provide written informed consent (including consent for the use and disclosure of research-related health information) and comply with the study procedures (including required study visits).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (ie, cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an adverse event (AE) in the Phase 3 study that could, in the opinion of the principal investigator, put the subject at undue risk.

2.Have developed any other medical diseases (eg, cardiopulmonary), laboratory abnormalities, or conditions (eg, poor venous access) that, in the opinion of the principal investigator, makes the subject unsuitable for the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To provide continuing treatment to subjects with SLE who complete HGS1006-C1056 or HGS1006-C1057.<br>To evaluate the long-term safety and tolerability of belimumab in subjects with SLE.;Secondary Objective: No secondary objectives in the protocol;Primary end point(s): This continuation trial is voluntary; there is no statistical sample size calculation. All analyses will be performed using descriptive statistics.