Back to resultsBelimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Belimumab
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring treatment holiday, PGA, belimumab, Lymphostat-B, rebound, SELENA SLEDAI, Systemic Lupus Erythematosus, immunogenicity
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- Subjects who wish to enroll in the long-term discontinuation group have voluntarily withdrawn from their continuation studies.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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Treatment Holiday Group
Control Group
Long-Term Discontinuation Group
Arm Description
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.
Subjects in the Control Group will continue to receive monthly belimumab therapy, in addition to standard of care SLE therapy for 52 weeks.
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.
Outcomes
Primary Outcome Measures
Median Time to First SLE Flare Index (SFI)
SFI Flare was defined as a mild/moderate or severe flare according to the modified Safety of Estrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) SLE Flare Index (modified excluded severe flares from the SELENA SLEDAI flare assessment that were triggered only by an increase in SELENA SLEDAI score to >12).Time to first SFI flare is defined as the number of days from Day 0 visit date to the date the participant has a flare (event date - Day 0 visit date + 1) in the 52 Week/Holiday phase; (event date - treatment re-start date + 1) in the Re-start Holiday phase. Day 0 visit date is defined as Day 0 from present study. Median time to first SFI flare is reported; estimated using the product-limit method.
Secondary Outcome Measures
Rate of SLE Index Flare Per Subject Year
Rate per subject year of SFI flare was calculated as total number of flares divided by total subject years in interval. The total subject years for each participant was calculated as (Week 52/ Exit visit date minus Day 0 visit date + 1) for Long-term discontinuation and treatment control groups. For treatment holiday phase group the subject-years for each participant was calculated as (Week 24/Treatment Re-start/Exit visit date minus Day 0 Visit date + 1)/365.25. For re-start treatment holiday phase group the subject-years for each participant was calculated as (Week 52/Exit visit date minus Week 24/Treatment Re-start date + 1)/365.25. Day 0 visit date is defined as Day 0 from present study.
Median Time to First Severe SFI Flare
The SLE Flare Index categorizes SLE flare as "mild or moderate" or "severe" based on a positive assessment for at least 1 of 5 variables as follows: Change in SELENA SLEDAI score from the most recent assessment to current; Change in signs or symptoms of disease activity; Change in prednisone dosage; Use of new medications for disease activity or hospitalization; Change in Physician's Global Assessment (PGA) score; Hospitalization for SLE activity is an additional category included only for a severe flare. Time to first severe flare is defined as (event date-Day 0 visit date) + 1 for Long-term discontinuation, treatment control groups and holiday phase group. For holiday phase group data censored at last flare assessment by treatment re-start date. Time to first severe flare is defined as (event date-treatment re-start date) + 1 for Re-start treatment holiday group. Median time to first severe SFI flare is reported; estimated using the product-limit method.
Number of Participants With Evidence of Rebound
Rebound is defined as SELENA SLEDAI score during the first 24 weeks that exceeds the Baseline SELENA SLEDAI score in the participant's respective original parent study. Baseline is defined as the Day 0 visit from the parent study. SELENA SLEDAI assessments consist of 24 individual weighted items in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed if present (marked 'Yes') at the time of the visit or in the preceding 10 days. The maximum theoretical score is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease (marked 'No'). Any time during the first 24 weeks of this study has been reported.
Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA)
Immunogenicity assay results were categorized as negative or positive. A persistent positive result was defined as a positive post-Day 0 visit immunogenic response that occurred for at least 2 consecutive assessments or a single result at the final assessment. A transient positive result was defined as a single post-Day 0 visit positive immunogenic response that did not occur at the final assessment. Any time post-Day 0 visit data are reported (or post-Week 24 for Treatment Holiday - Restart phase). Day 0 visit date is defined as Day 0 from present study.
Percentage Change From Baseline in Immunoglobulin
Serum samples were collected at indicated time-points for analysis of immunoglobulins: Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM). Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100* (value at specified visit minus Baseline value) divided by Baseline value.
Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA)
Blood samples were collected at indicated time-points for analysis of autoantibodies like dsDNA. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100* (Value at specified visit minus Baseline value) divided by Baseline value.
Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA)
Blood samples were collected at indicated time-points for analysis of autoantibodies like ANA. Only participants who had an ANA value measured in INDEX at the parent studies Baseline were included in this analysis. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100* (Value at specified visit minus Baseline value) divided by Baseline value.
Percentage Change From Baseline in Complement Levels
Blood samples were collected at indicated time-points for analysis of complement levels like complement 3 (C3) and complement 4 (C4). Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100* (Value at specified visit minus Baseline value) divided by Baseline value.
Percentage Change From Baseline in B Cell Subsets
Blood samples were collected at indicated time-points for analysis of Activated B cells subsets like Activated CD19+CD20+CD69+, cluster of differentiation 20+ (CD20+), Memory CD19+CD20+CD27+, Naive CD19+CD20+CD27-, Plasma CD19+CD20-CD138+, Plasmacytoid CD19+CD20+CD138+, and SLE Subset CD19+CD38b+CD27b+Lymph. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100* (Value at specified visit minus Baseline value) divided by Baseline value.
Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase)
Blood samples were collected at indicated time-points for analysis of Activated B cells subsets like Activated CD19+CD20+CD69+, CD20+, Memory CD19+CD20+CD27+, Naive CD19+CD20+CD27-, Plasma CD19+CD20-CD138+, Plasmacytoid CD19+CD20+CD138+, and SLE Subset CD19+CD38b+CD27b+Lymph. Percentage change from Week 24 of present study was calculated as 100*(value at specified visit - Week 24 value) divided by week 24 value. The data below is only reported for the Treatment Holiday Group (Re-start phase). Participants in this group restarted belimumab therapy one day after Week 24, hence the Baseline for this outcome measure was Week 24 visit. No other groups were measured for this outcome.
SELENA SLEDAI Scores Change From Baseline
SELENA SLEDAI assessments consist of 24 individual weighted items in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed if present (marked 'Yes') at the time of the visit or in the preceding 10 days. The maximum theoretical score is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease (marked 'No'). Data are reported at the specified time-points from Day 0 (of present study) up to Week 52. Baseline is defined as the Day 0 from parent studies. Change from Baseline is equal to (Value at specified visit minus Baseline value).
Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study
All corticosteroids are converted to a prednisone equivalent average daily dose (mg/day). The average daily dose at Day 0 was used to assess the relative change in daily dose on a given day. The average daily dose at Day 0 was calculated as sum of the daily dose across all days from the Screening visit date up to and including Day 0 visit date divided by the number of days in the time period. Data reported are the median number of days on which the specified criteria was met for Day 0 to Week 24, Week 24 to Week 52, Day 0 to Week 52. For treatment holiday group, Day 0 to Week 24 corresponds to holiday phase, Week 24 to Week 52 corresponds to treatment Re-start phase.
Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study
All corticosteroids are converted to a prednisone equivalent average daily dose (mg/day). The average daily dose at Day 0 was used to assess the relative change in daily dose on a given day. The average daily dose at Day 0 was calculated as sum of the daily dose across all days from the Screening visit date up to and including Day 0 visit date divided by the number of days in the time period. Data reported are the median number of days on which the specified criteria was met for Day 0 to Week 24, Week 24 to Week 52, Day 0 to Week 52. For treatment holiday group, Day 0 to Week 24 corresponds to holiday phase, Week 24 to Week 52 corresponds to treatment Re-start phase.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02119156
Brief Title
Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 13, 2014 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
December 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
treatment holiday, PGA, belimumab, Lymphostat-B, rebound, SELENA SLEDAI, Systemic Lupus Erythematosus, immunogenicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Holiday Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Subjects in the Control Group will continue to receive monthly belimumab therapy, in addition to standard of care SLE therapy for 52 weeks.
Arm Title
Long-Term Discontinuation Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Belimumab
Intervention Description
Monthly intravenous infusions dosed as 10 mg/kg body weight
Primary Outcome Measure Information:
Title
Median Time to First SLE Flare Index (SFI)
Description
SFI Flare was defined as a mild/moderate or severe flare according to the modified Safety of Estrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) SLE Flare Index (modified excluded severe flares from the SELENA SLEDAI flare assessment that were triggered only by an increase in SELENA SLEDAI score to >12).Time to first SFI flare is defined as the number of days from Day 0 visit date to the date the participant has a flare (event date - Day 0 visit date + 1) in the 52 Week/Holiday phase; (event date - treatment re-start date + 1) in the Re-start Holiday phase. Day 0 visit date is defined as Day 0 from present study. Median time to first SFI flare is reported; estimated using the product-limit method.
Time Frame
Up to 52 weeks
Secondary Outcome Measure Information:
Title
Rate of SLE Index Flare Per Subject Year
Description
Rate per subject year of SFI flare was calculated as total number of flares divided by total subject years in interval. The total subject years for each participant was calculated as (Week 52/ Exit visit date minus Day 0 visit date + 1) for Long-term discontinuation and treatment control groups. For treatment holiday phase group the subject-years for each participant was calculated as (Week 24/Treatment Re-start/Exit visit date minus Day 0 Visit date + 1)/365.25. For re-start treatment holiday phase group the subject-years for each participant was calculated as (Week 52/Exit visit date minus Week 24/Treatment Re-start date + 1)/365.25. Day 0 visit date is defined as Day 0 from present study.
Time Frame
Up to 52 weeks
Title
Median Time to First Severe SFI Flare
Description
The SLE Flare Index categorizes SLE flare as "mild or moderate" or "severe" based on a positive assessment for at least 1 of 5 variables as follows: Change in SELENA SLEDAI score from the most recent assessment to current; Change in signs or symptoms of disease activity; Change in prednisone dosage; Use of new medications for disease activity or hospitalization; Change in Physician's Global Assessment (PGA) score; Hospitalization for SLE activity is an additional category included only for a severe flare. Time to first severe flare is defined as (event date-Day 0 visit date) + 1 for Long-term discontinuation, treatment control groups and holiday phase group. For holiday phase group data censored at last flare assessment by treatment re-start date. Time to first severe flare is defined as (event date-treatment re-start date) + 1 for Re-start treatment holiday group. Median time to first severe SFI flare is reported; estimated using the product-limit method.
Time Frame
Up to 52 weeks
Title
Number of Participants With Evidence of Rebound
Description
Rebound is defined as SELENA SLEDAI score during the first 24 weeks that exceeds the Baseline SELENA SLEDAI score in the participant's respective original parent study. Baseline is defined as the Day 0 visit from the parent study. SELENA SLEDAI assessments consist of 24 individual weighted items in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed if present (marked 'Yes') at the time of the visit or in the preceding 10 days. The maximum theoretical score is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease (marked 'No'). Any time during the first 24 weeks of this study has been reported.
Time Frame
Up to 24 weeks
Title
Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA)
Description
Immunogenicity assay results were categorized as negative or positive. A persistent positive result was defined as a positive post-Day 0 visit immunogenic response that occurred for at least 2 consecutive assessments or a single result at the final assessment. A transient positive result was defined as a single post-Day 0 visit positive immunogenic response that did not occur at the final assessment. Any time post-Day 0 visit data are reported (or post-Week 24 for Treatment Holiday - Restart phase). Day 0 visit date is defined as Day 0 from present study.
Time Frame
Up to 52 weeks
Title
Percentage Change From Baseline in Immunoglobulin
Description
Serum samples were collected at indicated time-points for analysis of immunoglobulins: Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM). Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100* (value at specified visit minus Baseline value) divided by Baseline value.
Time Frame
Baseline (Day 0 from parent studies); Day 0 and 8, 16, 24, 32, 40, 48 and 52 weeks
Title
Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA)
Description
Blood samples were collected at indicated time-points for analysis of autoantibodies like dsDNA. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100* (Value at specified visit minus Baseline value) divided by Baseline value.
Time Frame
Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks
Title
Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA)
Description
Blood samples were collected at indicated time-points for analysis of autoantibodies like ANA. Only participants who had an ANA value measured in INDEX at the parent studies Baseline were included in this analysis. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100* (Value at specified visit minus Baseline value) divided by Baseline value.
Time Frame
Baseline (Day 0 from parent studies); Day 0 and 24 and 52 weeks
Title
Percentage Change From Baseline in Complement Levels
Description
Blood samples were collected at indicated time-points for analysis of complement levels like complement 3 (C3) and complement 4 (C4). Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100* (Value at specified visit minus Baseline value) divided by Baseline value.
Time Frame
Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks
Title
Percentage Change From Baseline in B Cell Subsets
Description
Blood samples were collected at indicated time-points for analysis of Activated B cells subsets like Activated CD19+CD20+CD69+, cluster of differentiation 20+ (CD20+), Memory CD19+CD20+CD27+, Naive CD19+CD20+CD27-, Plasma CD19+CD20-CD138+, Plasmacytoid CD19+CD20+CD138+, and SLE Subset CD19+CD38b+CD27b+Lymph. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100* (Value at specified visit minus Baseline value) divided by Baseline value.
Time Frame
Baseline (Day 0 from parent studies); Day 0 and 8, 16, 24, 32, 40 and 52 weeks
Title
Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase)
Description
Blood samples were collected at indicated time-points for analysis of Activated B cells subsets like Activated CD19+CD20+CD69+, CD20+, Memory CD19+CD20+CD27+, Naive CD19+CD20+CD27-, Plasma CD19+CD20-CD138+, Plasmacytoid CD19+CD20+CD138+, and SLE Subset CD19+CD38b+CD27b+Lymph. Percentage change from Week 24 of present study was calculated as 100*(value at specified visit - Week 24 value) divided by week 24 value. The data below is only reported for the Treatment Holiday Group (Re-start phase). Participants in this group restarted belimumab therapy one day after Week 24, hence the Baseline for this outcome measure was Week 24 visit. No other groups were measured for this outcome.
Time Frame
Week 24, 32, 40 and 52 weeks
Title
SELENA SLEDAI Scores Change From Baseline
Description
SELENA SLEDAI assessments consist of 24 individual weighted items in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed if present (marked 'Yes') at the time of the visit or in the preceding 10 days. The maximum theoretical score is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease (marked 'No'). Data are reported at the specified time-points from Day 0 (of present study) up to Week 52. Baseline is defined as the Day 0 from parent studies. Change from Baseline is equal to (Value at specified visit minus Baseline value).
Time Frame
Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32,36, 40, 44, 48 and 52 weeks
Title
Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study
Description
All corticosteroids are converted to a prednisone equivalent average daily dose (mg/day). The average daily dose at Day 0 was used to assess the relative change in daily dose on a given day. The average daily dose at Day 0 was calculated as sum of the daily dose across all days from the Screening visit date up to and including Day 0 visit date divided by the number of days in the time period. Data reported are the median number of days on which the specified criteria was met for Day 0 to Week 24, Week 24 to Week 52, Day 0 to Week 52. For treatment holiday group, Day 0 to Week 24 corresponds to holiday phase, Week 24 to Week 52 corresponds to treatment Re-start phase.
Time Frame
Day 0 to Week 24; Week 24 to Week 52; Day 0 to Week 52
Title
Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study
Description
All corticosteroids are converted to a prednisone equivalent average daily dose (mg/day). The average daily dose at Day 0 was used to assess the relative change in daily dose on a given day. The average daily dose at Day 0 was calculated as sum of the daily dose across all days from the Screening visit date up to and including Day 0 visit date divided by the number of days in the time period. Data reported are the median number of days on which the specified criteria was met for Day 0 to Week 24, Week 24 to Week 52, Day 0 to Week 52. For treatment holiday group, Day 0 to Week 24 corresponds to holiday phase, Week 24 to Week 52 corresponds to treatment Re-start phase.
Time Frame
Day 0 to Week 24; Week 24 to Week 52; Day 0 to Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
GSK Investigational Site
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
GSK Investigational Site
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
GSK Investigational Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
GSK Investigational Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
GSK Investigational Site
City
Chiba
ZIP/Postal Code
275-8580
Country
Japan
Facility Name
GSK Investigational Site
City
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
060-8604
Country
Japan
Facility Name
GSK Investigational Site
City
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
GSK Investigational Site
City
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
GSK Investigational Site
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Suwon, Kyonggi-do
ZIP/Postal Code
443-721
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
35172878
Citation
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.
Results Reference
derived
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Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients
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