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Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients

An Open-label, Non-randomized, 52-Week Study to Evaluate Treatment Holidays and Rebound Phenomenon After Treatment With Belimumab 10 mg/kg in Systemic Lupus Erythematosus Subjects

NCT02119156•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.

Detailed Description

This study will assess the effect of a 24-week withdrawal of belimumab followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications on immunogenicity, markers of biological activity, efficacy, and safety in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Additionally, this study will assess rebound phenomenon in subjects with any disease level of SLE who have permanently withdrawn from further belimumab treatment

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Received a minimun of 6 months therapy with with belimumab 10 mg/kg in their current SLE belimumab continuation study.
•Be 18 years of age at the Day 0 visit.
•Non-prenant, non-lactating females willing to comply with specific birth control requirements as set forth in the protocol.
•Able to provide written informed consent to participate.
•Subjects who wish to enroll in the control group and the group taking a 6 month belimumab treatment holiday will need a SELENA SLEDAI score of 3 or less after the minimum of 6 months belimumab therapy, as well as having C3 and C4 complement levels at or above the lower limit of the central laboratory reference range, and are on a stable SLE treatment regimen during the 30 day screening period prior to Day 0.
•Subjects who wish to enroll in the long-term discontinuation group have voluntarily withdrawn from their continuation studies.

Exclusion Criteria

•Subjects who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE, or experienced an adverse event (AE) in their belimumab continuation study that could, in the opinion of the principle investigator, put the subject at undue risk.
•Subjects who have developed any other medical diseases, laboratory abnormalities, or conditions that, in the opinion of the principle investigator, makes the subject unsuitable for the study.

Locations (20)

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Manhasset, New York, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Hefei, Anhui, China

GSK Investigational Site

Suzhou, Jiangsu, China

GSK Investigational Site

Hangzhou, Zhejiang, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Ehime, Japan

Key Dates

Start Date

May 13, 2014

Primary Completion Date

December 14, 2018

Completion Date

December 14, 2018

Last Updated

January 31, 2020

Enrollment

ACTUAL participants

Conditions

Systemic Lupus Erythematosus

Interventions

Belimumab

DRUG

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Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients

Inclusion Criteria

Exclusion Criteria

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