Phase
Condition
Musculoskeletal Diseases
Connective Tissue Diseases
Scar Tissue
Treatment
Belimumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants with SSc-ILD or other CTD-ILDs that have completed either study 218224or 221672 through to and including the Week 52 visit and are not consideredtreatment failure, defined as meeting either of the following criteria:
Discontinuation of study medication during study 218224 or 221672 for anyreason.
Participants with SSc should have an area of uninvolved or mildly thickened skinthat, in the opinion of the investigator, would allow subcutaneous (SC) injection atthe abdomen or the front, middle region of the thigh.
Participant is capable and willing to self-administer the study medication or has acaregiver/healthcare professional who is capable and willing to administer the studymedication throughout the study.
Female participants: A female participant is eligible to participate if she is notpregnant or breastfeeding, and one of the following conditions applies:
Is a woman of non-childbearing potential (WONCBP) or is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (<)1 percentage (%), during the study treatment period and for at least 4 months after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention.
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, asrequired by local regulations) within 24 hours before the first dose of studyintervention.
If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serumpregnancy test is required. In such cases, the participant must be excluded fromparticipation if the serum pregnancy result is positive.
Additional requirements for pregnancy testing during and after study interventionare located.
The investigator is responsible for review of medical history, menstrual history,and recent sexual activity to decrease the risk for inclusion of a woman with anearly undetected pregnancy.
- Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and inthe protocol.
Exclusion
Exclusion Criteria:
Participants of study 218224 or study 221672 who have discontinued study treatment,prior to Week 52.
Participants who have developed clinical evidence of significant, unstable oruncontrolled, acute or chronic diseases not due to SSc or other CTD (i.e,cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal,neurological, malignancy or infectious diseases), or experienced an AE in study 218224 or study 221672 that could, in the opinion of the principal investigator, putthe participant at undue risk.
Participants who have developed any other medical diseases (eg, cardiopulmonary),laboratory abnormalities, or conditions (eg, poor venous access) that, in theopinion of the investigator could significantly alter the absorption, metabolism, orelimination of drugs; constitutes a risk when taking the study intervention;interferes with the interpretation of data; or it is not safe for the participant tocontinue on the study.
Participants who have been exposed to ionizing radiation in excess of 10millisievert (mSv) above background over the previous 3 year period as a result ofoccupational exposure or previous participation in research studies.
QT Interval Corrected (QTc) greater than (>) 480 millisecond (msec) at Week 52 ofparent study 218224 or study 221672.
Study Design
Connect with a study center
GSK Investigational Site
Ciudad Autonoma Buenos Aires, C1015ABO
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, 1425
ArgentinaActive - Recruiting
GSK Investigational Site
Porto Alegre, 90020-090
BrazilSite Not Available
GSK Investigational Site
Sao Paulo, 01308-050
BrazilSite Not Available
GSK Investigational Site
Beijing, 100020
ChinaActive - Recruiting
GSK Investigational Site
Beijing 1816670, 100020
ChinaActive - Recruiting
GSK Investigational Site
Chengdu, 610072
ChinaSite Not Available
GSK Investigational Site
Nanjing, 210029
ChinaSite Not Available
GSK Investigational Site
Shanghai, 200040
ChinaSite Not Available
GSK Investigational Site
Zhuzhou 1783763, 412007
ChinaActive - Recruiting
GSK Investigational Site
Athens, 11527
GreeceSite Not Available
GSK Investigational Site
Larissa 258576, 41110
GreeceActive - Recruiting
GSK Investigational Site
Roma, 00161
ItalySite Not Available
GSK Investigational Site
Hokkaido, 060-8648
JapanActive - Recruiting
GSK Investigational Site
Tokyo 1850147, 113-8603
JapanActive - Recruiting
GSK Investigational Site
Seoul, 04763
Korea, Republic ofSite Not Available
GSK Investigational Site
Yongsan-Ku Seoul,
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Yongsan-Ku Seoul,
South KoreaActive - Recruiting
GSK Investigational Site
Barcelona, 08025
SpainSite Not Available
GSK Investigational Site
Madrid, 28007
SpainSite Not Available
GSK Investigational Site
London 2643743, NW3 2QG
United KingdomActive - Recruiting
GSK Investigational Site
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesActive - Recruiting

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