A Study of Tabalumab (LY2127399) Using Two Different Inje... | NCT02041091 | Trialant
NCT02041091
Sponsor
Eli Lilly and Company
Status
Terminated
Last Update Posted
Jun 15, 2018Actual
Enrollment
226Actual
Phase
Phase 3
Conditions
Lupus Erythematosus, Systemic
Interventions
Tabalumab Auto-Injector
Tabalumab Prefilled Syringe
Countries
United States
Puerto Rico
South Korea
Protocol Section
Identification Module
NCT ID
NCT02041091
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15193
Secondary IDs
ID
Type
Description
Link
H9B-MC-BCEI
Other Identifier
Eli Lilly and Company
Brief Title
A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus
Official Title
Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus Erythematosus
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
May 2018
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Lack of efficacy
Expanded Access Info
No
Start Date
Jan 2014
Primary Completion Date
Oct 2014Actual
Completion Date
Nov 2015Actual
First Submitted Date
Jan 17, 2014
First Submission Date that Met QC Criteria
Jan 17, 2014
First Posted Date
Jan 20, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 24, 2018
Results First Submitted that Met QC Criteria
May 16, 2018
Results First Posted Date
Jun 15, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 8, 2016
Certification/Extension First Submitted that Passed QC Review
Apr 8, 2016
Certification/Extension First Posted Date
May 5, 2016Estimated
Last Update Submitted Date
May 16, 2018
Last Update Posted Date
Jun 15, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the amount of tabalumab in the blood after it is given by two different injection methods - A traditional syringe or a spring loaded syringe for 12 weeks. Participants may continue to receive study drug for up to 52 weeks.
Detailed Description
Not provided
Conditions Module
Conditions
Lupus Erythematosus, Systemic
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
226Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Tabalumab Auto-Injector
Experimental
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Drug: Tabalumab Auto-Injector
Tabalumab Prefilled Syringe
Experimental
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Drug: Tabalumab Prefilled Syringe
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Tabalumab Auto-Injector
Drug
Administered SC
Tabalumab Auto-Injector
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose
Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose
Area under the concentration time curve after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using NCA methods to calculate the geometric mean.
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Secondary Outcomes
Measure
Description
Time Frame
Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight
Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval , stratified by body weight (low <60 kilograms (kg), medium 60kg- 100kg, high >100kg).PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using NCA methods to calculate the geometric mean.
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Lupus.
Able and willing to have blood drawn for PK sampling.
Exclusion Criteria:
Have severe active lupus nephritis.
Have severe active central nervous system (CNS) or peripheral neurologic disease or other severe neurologic involvement requiring treatment within approximately 3 months prior to screening.
Have received high dose corticosteroid within approximately 1 month prior to baseline.
Have initiated or adjusted treatment with immunosuppressant drugs within approximately 1 month prior to baseline.
Have received plasmapheresis within approximately 3 months prior to baseline.
Have previously received approved or experimental B cell targeted therapies within the last year.
Have received any biologic or non-biologic therapy within approximately 3 months or 5 half-lives (whichever is longer).
Have a history of severe reaction to any biologic therapy.
Have an active or recent infection within approximately 1 month prior to Week 0.
Have had a serious infection within approximately 3 month or serious bone/joint infection within approximately 6 months prior to baseline.
Have evidence of or test positive for active hepatitis B or are positive for hepatitis C or human immunodeficiency virus (HIV).
Have evidence of active or latent tuberculosis.
Have significant hematological abnormalities.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Medvin Clinical Research
Covina
California
91723
United States
TriWest Research Associates
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants who complete the Treatment Period will have the option of participating in the Optional Safety Extension Period through Week 52.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Tabalumab Prefilled Syringe
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
The treatment regimen from Week 12 to Week 52 is an Optional Safety Extension Period.
All participants will participate in a Post-Treatment Follow-Up Period regardless of their participation in the Optional Safety Extension Period.
Periods
Title
Milestones
Reasons Not Completed
Treatment
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Mexico
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
LY2127399
Tabalumab Prefilled Syringe
Drug
Administered SC
Tabalumab Prefilled Syringe
LY2127399
Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight
Area under the concentration time curve after the loading dose, assessed over the 14-day dosing interval, stratified by body weight (low <60 kilograms (kg), medium 60kg- 100kg, high >100kg). PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Number of Participants Reporting Incomplete Tabalumab Dose Administration
Participants reporting incomplete dose administration from the study drug administration log.
Week 0 through Week 12
Number of Participants Developing Anti-Tabalumab Antibodies
Participants with treatment-emergent anti-tabalumab antibodies were participants who had any samples from baseline up to and through Week 12 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of tabalumab. Percentage of participants with anti-tabalumab antibodies = (number of participants with treatment-emergent anti-tabalumab antibodies / number of participants assessed)*100.
The SQAAQ is a 12-item questionnaire using a 7-point Likert scale (from "Strongly Disagree" as 1 to "Strongly Agree" as 7) that provides assessment of ease of use and confidence with using a prefilled syringe or auto-injector to administer a subcutaneous injection of drug. The 12 items are: A-Easy for me to learn how to use, B-Easy for me to unlock, C- Easy to hold in my hand when I inject my dose, D- Easy to inject my dose, E- Easy to know that my dose is complete, F- Easy to store the device in my refrigerator, G- Easy to remove needle shield/cover, H- Easy to pick up, I- Overall, easy to use, J- The device is stable against my skin during the injection, K- I am confident in my ability to use the device, L- I am confident my dose is complete.
Week 0, Week 4 and Week 8
Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications
Maximum serum concentration of tabalumab in medium body weight group, after the loading dose via auto-injector, assessed over the 14-day dosing interval, stratified by injection site. PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications
Area under the concentration time curve in medium body weight group after the loading dose via auto-injector, assessed over the 14-day dosing interval, stratified by injection site. PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
El Cajon
California
92020
United States
ProHealth Partners Medical Group
Long Beach
California
90808
United States
Wallace Rheumatic Study Center
Los Angeles
California
90048
United States
Desert Medical Advances
Palm Desert
California
92260
United States
Inlande Rheumatology Clinical Trials
Upland
California
91786
United States
Denver Arthritis Center
Denver
Colorado
80230
United States
New England Research Associates
Trumbull
Connecticut
06611
United States
Advanced Pharma Clinical Research
Miami
Florida
33136
United States
New Horizon Research Center
Miami
Florida
33175
United States
Arthritis Research of Florida
Palm Harbor
Florida
34684
United States
Clinical Research of West Florida, Inc.
Tampa
Florida
33603
United States
Indiana University Health
Indianapolis
Indiana
46202
United States
The Arthritis & Diabetes Clinic Inc.
Monroe
Louisiana
71203
United States
West Michigan Rheumatology
Grand Rapids
Michigan
49546
United States
Clayton Medical Research
St Louis
Missouri
63117
United States
Physician Research Collaboration, LLC
Lincoln
Nebraska
68516
United States
Westroads Clinical Research-Omaha
Omaha
Nebraska
68114
United States
Innovative Health Research
Las Vegas
Nevada
89128
United States
(AOA) Arthritis & Osteoporosis Associates
Freehold
New Jersey
07728
United States
Albuquerque Clinical Trials
Albuquerque
New Mexico
87102
United States
The Feinstein Institute for Medical Research
Manhasset
New York
11030
United States
Box Arthritis & Rheumatology of the Carolinas, PLLC
Charlotte
North Carolina
28210
United States
PharmQuest
Greensboro
North Carolina
27408
United States
Shanahan Rheumatology & Immunotherapy
Raleigh
North Carolina
27617
United States
PMG Research of Salisbury
Salisbury
North Carolina
28144
United States
Paramount Medical Research
Middleburg Heights
Ohio
44130
United States
Oklahoma Arthritis Center
Edmond
Oklahoma
73013
United States
Altoona Center for Clinical Research
Duncansville
Pennsylvania
16635
United States
Clinical Research Center of Reading, LLP
Wyomissing
Pennsylvania
19610
United States
Low Country Research Center
North Charleston
South Carolina
29406
United States
Tekton Research, Inc.
Austin
Texas
78745
United States
Sun Research Institute
San Antonio
Texas
78215
United States
Virginia Clinical Research
Norfolk
Virginia
23507
United States
Arthritis Northwest Rheumatology
Spokane
Washington
99204
United States
Mountain State Clinical Research
Clarksburg
West Virginia
26301
United States
Office: Perez de Jesus, Amarylis
Caguas
00725
Puerto Rico
Ramon L. Ortega Colon
Carolina
00983
Puerto Rico
GCM Medical Group PSC
San Juan
00909
Puerto Rico
Mindful Medical Research
San Juan
00918
Puerto Rico
Latin Clinical Trial Center
Santurce
00909
Puerto Rico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Daejeon
301-721
South Korea
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Incheon
405-760
South Korea
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul
143-729
South Korea
FG001
Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
The treatment regimen from Week 12 to Week 52 is an Optional Safety Extension Period.
All participants will participate in a Post-Treatment Follow-Up Period regardless of their participation in the Optional Safety Extension Period.
FG000112 subjects
FG001114 subjects
Received At Least One Dose of Study Drug
FG000112 subjects
FG001114 subjects
Participated in Follow Up
FG000106 subjects
FG00196 subjects
COMPLETED
FG00090 subjects
FG00191 subjects
NOT COMPLETED
FG00022 subjects
FG00123 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0013 subjects
Withdrawal by Subject
FG0002 subjects
FG0014 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
Sponsor Decision
FG00015 subjects
FG00116 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
Optional Safety Extension Period
Type
Comment
Milestone Data
STARTED
FG00085 subjectsParticipation was optional for the Safety Extension Period.
FG00182 subjectsParticipation was optional for the Safety Extension Period.
COMPLETED
FG0000 subjects
FG0010 subjects
NOT COMPLETED
FG00085 subjects
FG00182 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0012 subjects
Withdrawal by Subject
FG0005 subjects
FG001
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Tabalumab Prefilled Syringe
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
BG001
Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000112
BG001114
BG002226
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00047.03± 12.691
BG00144.93± 13.306
BG00245.97± 13.018
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000106
BG001108
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00026
BG00132
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG00099
BG001101
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose
Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram per milliliter (ug/mL)
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
ID
Title
Description
OG000
Tabalumab Prefilled Syringe
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Tabalumab Prefilled Syringe: Administered SC
OG001
Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector: Administered SC
Units
Counts
Participants
OG00087
OG00199
Title
Denominators
Categories
Title
Measurements
OG00035.7± 53.2
OG00134.1± 46.5
Primary
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose
Area under the concentration time curve after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using NCA methods to calculate the geometric mean.
PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram*hour per milliliter (ug*hr/mL)
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
ID
Title
Description
OG000
Tabalumab Prefilled Syringe
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Tabalumab Prefilled Syringe: Administered SC
OG001
Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector: Administered SC
Secondary
Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight
Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval , stratified by body weight (low <60 kilograms (kg), medium 60kg- 100kg, high >100kg).PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using NCA methods to calculate the geometric mean.
PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data. The analyses was conducted on tabalumab exposure parameter from both arms combined per the statistical analysis plan, since the tabalumab exposure was similar following prefilled syringe and auto-injector injections.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
ID
Title
Description
OG000
Total PK Population
Total participants randomized to prefilled syringe or auto-injector arm from randomization through week 61.
Units
Counts
Participants
OG000
Secondary
Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight
Area under the concentration time curve after the loading dose, assessed over the 14-day dosing interval, stratified by body weight (low <60 kilograms (kg), medium 60kg- 100kg, high >100kg). PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data. The analyses was conducted on tabalumab exposure parameter from both arms combined per the statistical analysis plan, since the tabalumab exposure was similar following prefilled syringe and auto-injector injections.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug*hr/mL
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
ID
Title
Description
OG000
Total PK Population
Total participants randomized to prefilled syringe or auto-injector arm from randomization through week 61.
Units
Counts
Participants
OG000
Secondary
Number of Participants Reporting Incomplete Tabalumab Dose Administration
Participants reporting incomplete dose administration from the study drug administration log.
Safety population: all randomized patients who received at least 1 dose of study treatment.
Posted
Count of Participants
Participants
Week 0 through Week 12
ID
Title
Description
OG000
Tabalumab Prefilled Syringe
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Tabalumab Prefilled Syringe: Administered SC
OG001
Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector: Administered SC
Units
Counts
Participants
Secondary
Number of Participants Developing Anti-Tabalumab Antibodies
Participants with treatment-emergent anti-tabalumab antibodies were participants who had any samples from baseline up to and through Week 12 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of tabalumab. Percentage of participants with anti-tabalumab antibodies = (number of participants with treatment-emergent anti-tabalumab antibodies / number of participants assessed)*100.
Safety population: all randomized participants who received at least 1 dose of study treatment. Participants with a baseline sample and at least 1 evaluable sample after administration of study drug OR participants with no baseline sample and all evaluable post-baseline samples.
Posted
Count of Participants
Participants
Week 0 through Week 12
ID
Title
Description
OG000
Tabalumab Prefilled Syringe
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Tabalumab Prefilled Syringe: Administered SC
OG001
Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
The SQAAQ is a 12-item questionnaire using a 7-point Likert scale (from "Strongly Disagree" as 1 to "Strongly Agree" as 7) that provides assessment of ease of use and confidence with using a prefilled syringe or auto-injector to administer a subcutaneous injection of drug. The 12 items are: A-Easy for me to learn how to use, B-Easy for me to unlock, C- Easy to hold in my hand when I inject my dose, D- Easy to inject my dose, E- Easy to know that my dose is complete, F- Easy to store the device in my refrigerator, G- Easy to remove needle shield/cover, H- Easy to pick up, I- Overall, easy to use, J- The device is stable against my skin during the injection, K- I am confident in my ability to use the device, L- I am confident my dose is complete.
Safety population: all randomized patients who received at least 1 dose of study treatment.
Posted
Mean
Standard Deviation
units on a scale
Week 0, Week 4 and Week 8
ID
Title
Description
OG000
Tabalumab Prefilled Syringe
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Tabalumab Prefilled Syringe: Administered SC
OG001
Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector: Administered SC
Secondary
Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications
Maximum serum concentration of tabalumab in medium body weight group, after the loading dose via auto-injector, assessed over the 14-day dosing interval, stratified by injection site. PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
PK population (all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data) in medium body weight group, dosed by auto-injector.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
ID
Title
Description
OG000
Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector: Administered SC
Units
Counts
Participants
OG000
Secondary
Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications
Area under the concentration time curve in medium body weight group after the loading dose via auto-injector, assessed over the 14-day dosing interval, stratified by injection site. PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
PK population (all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data) in medium body weight group, dosed by auto-injector.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg*hr/mL
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
ID
Title
Description
OG000
Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector: Administered SC
Units
Counts
Participants
Time Frame
Not provided
Description
All participants who received at least 1 dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Tabalumab Prefilled Syringe Treatment
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks.
1
112
79
112
EG001
Tabalumab Auto-Injector Treatment
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks.
1
114
65
114
EG002
Prefilled Syringe Optional Safety Extension
Tabalumab given SC every two weeks from Week 12 to Week 52.
1
85
37
85
EG003
Auto-Injector Optional Safety Extension
Tabalumab given every two weeks from Week 12 to Week 52.