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

NCT ID: NCT02119156

Last Updated: 2020-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-13
• Study Completion Date: 2018-12-14

Brief 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 Rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.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Additionally, this study will assess rebound phenomenon in subjects with any disease level of SLE who have permanently withdrawn from further belimumab treatment

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Holiday Group

Subjects in the Treatment Holiday Group will undergo a 6 month belimumab treatment holiday while remaining on standard of care SLE therapy, then re-start belimumab therapy for 6 months while receiving standard of care SLE therapy.

Group Type: EXPERIMENTAL

Belimumab

Intervention Type: DRUG

Monthly intravenous infusions dosed as 10 mg/kg body weight

Control Group

Subjects in the Control Group will continue to receive monthly belimumab therapy, in addition to standard of care SLE therapy for 52 weeks.

Group Type: ACTIVE_COMPARATOR

Belimumab

Intervention Type: DRUG

Monthly intravenous infusions dosed as 10 mg/kg body weight

Long-Term Discontinuation Group

Subjects in the Long-Term Discontinuation Group have elected to discontinue further belimumab therapy and will remain on standard of care SLE therapy as directed by the investigator, and agree to return for monthly visits for 52 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Belimumab

Monthly intravenous infusions dosed as 10 mg/kg body weight

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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

GSK Investigational Site

Hokkaido, , Japan

GSK Investigational Site

Miyagi, , Japan

GSK Investigational Site

Nagasaki, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Daegu, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Suwon, Kyonggi-do, , South Korea

Countries

United States; China; Japan; South Korea

References

Bae SC, Bass DL, Chu M, Curtis P, Dimelow R, Harvey L, Ji B, Kurrasch R, Muzaffar S, Punwaney R, Roth DA, Song YW, Xie W, Zhang F. The effect of 24-week belimumab treatment withdrawal followed by treatment restart in patients with SLE: an open-label, non-randomised 52-week study. Arthritis Res Ther. 2022 Feb 16;24(1):46. doi: 10.1186/s13075-022-02723-y.

Reference Type: DERIVED

PMID: 35172878 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

116027

Identifier Type: -

Identifier Source: org_study_id