Lupus Erythematosus, Systemic
Conditions
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.
Interventions
Administered SC
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose | Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab | 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. |
| Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose | Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Incomplete Tabalumab Dose Administration | Week 0 through Week 12 | Participants reporting incomplete dose administration from the study drug administration log. |
| Number of Participants Developing Anti-Tabalumab Antibodies | Week 0 through Week 12 | 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. |
| Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight | Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab | 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. |
| Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications | Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab | 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. |
| Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications | Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab | 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. |
| Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0, Week 4 and Week 8 | 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. |
| Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight | Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab | 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. |
Countries
Puerto Rico, South Korea, United States
Participant flow
Pre-assignment details
Participants who complete the Treatment Period will have the option of participating in the Optional Safety Extension Period through Week 52.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 112 |
| 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. | 114 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Optional Safety Extension Period | Adverse Event | 4 | 2 |
| Optional Safety Extension Period | Lost to Follow-up | 2 | 3 |
| Optional Safety Extension Period | Physician Decision | 2 | 1 |
| Optional Safety Extension Period | Protocol Violation | 2 | 0 |
| Optional Safety Extension Period | Sponsor Decision | 70 | 74 |
| Optional Safety Extension Period | Withdrawal by Subject | 5 | 2 |
| Treatment | Adverse Event | 3 | 3 |
| Treatment | Lost to Follow-up | 1 | 0 |
| Treatment | Physician Decision | 1 | 0 |
| Treatment | Sponsor Decision | 15 | 16 |
| Treatment | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Tabalumab Prefilled Syringe | Total | Tabalumab Auto-Injector |
|---|---|---|---|
| Age, Continuous | 47.03 years STANDARD_DEVIATION 12.691 | 45.97 years STANDARD_DEVIATION 13.018 | 44.93 years STANDARD_DEVIATION 13.306 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 58 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 164 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 28 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 37 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 82 Participants | 158 Participants | 76 Participants |
| Region of Enrollment South Korea | 13 Participants | 26 Participants | 13 Participants |
| Region of Enrollment United States | 99 Participants | 200 Participants | 101 Participants |
| Sex: Female, Male Female | 106 Participants | 214 Participants | 108 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 79 / 112 | 65 / 114 | 37 / 85 | 25 / 82 | 7 / 106 | 15 / 96 |
| serious Total, serious adverse events | 1 / 112 | 1 / 114 | 1 / 85 | 2 / 82 | 4 / 106 | 8 / 96 |
Outcome results
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.
Time frame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Population: PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tabalumab Prefilled Syringe | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose | 8390 microgram*hour per milliliter (ug*hr/mL) | Geometric Coefficient of Variation 44 |
| Tabalumab Auto-Injector | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose | 8170 microgram*hour per milliliter (ug*hr/mL) | Geometric Coefficient of Variation 41.3 |
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.
Time frame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Population: PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tabalumab Prefilled Syringe | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose | 35.7 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 53.2 |
| Tabalumab Auto-Injector | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose | 34.1 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 46.5 |
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.
Time frame: Week 0 through Week 12
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tabalumab Prefilled Syringe | Number of Participants Developing Anti-Tabalumab Antibodies | 1 Participants |
| Tabalumab Auto-Injector | Number of Participants Developing Anti-Tabalumab Antibodies | 0 Participants |
Secondary
Number of Participants Reporting Incomplete Tabalumab Dose Administration
Participants reporting incomplete dose administration from the study drug administration log.
Time frame: Week 0 through Week 12
Population: Safety population: all randomized patients who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tabalumab Prefilled Syringe | Number of Participants Reporting Incomplete Tabalumab Dose Administration | 0 Participants |
| Tabalumab Auto-Injector | Number of Participants Reporting Incomplete Tabalumab Dose Administration | 1 Participants |
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.
Time frame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Tabalumab Prefilled Syringe | Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight | Low | 10800 ug*hr/mL | Geometric Coefficient of Variation 31.9 |
| Tabalumab Prefilled Syringe | Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight | Medium | 8450 ug*hr/mL | Geometric Coefficient of Variation 35.5 |
| Tabalumab Prefilled Syringe | Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight | High | 6160 ug*hr/mL | Geometric Coefficient of Variation 36.7 |
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.
Time frame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Tabalumab Prefilled Syringe | Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications | Arm | 7380 μg*hr/mL | Geometric Coefficient of Variation 36 |
| Tabalumab Prefilled Syringe | Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications | Abdomen | 8890 μg*hr/mL | Geometric Coefficient of Variation 27.9 |
| Tabalumab Prefilled Syringe | Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications | Thigh | 10000 μg*hr/mL | Geometric Coefficient of Variation 34 |
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.
Time frame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Tabalumab Prefilled Syringe | Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight | Low | 47.8 μg/mL | Geometric Coefficient of Variation 40.5 |
| Tabalumab Prefilled Syringe | Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight | Medium | 34.7 μg/mL | Geometric Coefficient of Variation 42.5 |
| Tabalumab Prefilled Syringe | Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight | High | 25.4 μg/mL | Geometric Coefficient of Variation 40.1 |
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.
Time frame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Tabalumab Prefilled Syringe | Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications | Arm | 29.4 μg/mL | Geometric Coefficient of Variation 38.1 |
| Tabalumab Prefilled Syringe | Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications | Abdomen | 37 μg/mL | Geometric Coefficient of Variation 35.4 |
| Tabalumab Prefilled Syringe | Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications | Thigh | 42.2 μg/mL | Geometric Coefficient of Variation 52.6 |
Secondary
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
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.
Time frame: Week 0, Week 4 and Week 8
Population: Safety population: all randomized patients who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: F | 6.6 units on a scale | Standard Deviation 0.84 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: D | 6.6 units on a scale | Standard Deviation 0.96 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: E | 6.6 units on a scale | Standard Deviation 0.86 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: F | 6.8 units on a scale | Standard Deviation 0.73 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: G | 6.6 units on a scale | Standard Deviation 0.89 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: H | 6.8 units on a scale | Standard Deviation 0.48 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: I | 6.7 units on a scale | Standard Deviation 0.81 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: J | 6.6 units on a scale | Standard Deviation 1.03 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: K | 6.7 units on a scale | Standard Deviation 0.82 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: L | 6.8 units on a scale | Standard Deviation 0.58 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: A | 6.5 units on a scale | Standard Deviation 1.14 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: B | 5.9 units on a scale | Standard Deviation 1.39 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: C | 6.3 units on a scale | Standard Deviation 1.24 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: D | 6.4 units on a scale | Standard Deviation 1.12 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: E | 6.5 units on a scale | Standard Deviation 0.92 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: F | 6.6 units on a scale | Standard Deviation 0.82 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: G | 6.3 units on a scale | Standard Deviation 1.31 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: H | 6.6 units on a scale | Standard Deviation 0.82 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: I | 6.4 units on a scale | Standard Deviation 1.06 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: J | 6.4 units on a scale | Standard Deviation 1.12 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: K | 6.6 units on a scale | Standard Deviation 0.93 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: L | 6.7 units on a scale | Standard Deviation 0.81 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: A | 6.7 units on a scale | Standard Deviation 0.59 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: B | 6.4 units on a scale | Standard Deviation 0.94 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: C | 6.5 units on a scale | Standard Deviation 0.97 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: D | 6.5 units on a scale | Standard Deviation 0.97 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: E | 6.5 units on a scale | Standard Deviation 0.95 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: G | 6.5 units on a scale | Standard Deviation 0.77 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: H | 6.7 units on a scale | Standard Deviation 0.59 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: I | 6.5 units on a scale | Standard Deviation 0.87 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: J | 6.5 units on a scale | Standard Deviation 0.92 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: K | 6.6 units on a scale | Standard Deviation 0.68 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: L | 6.7 units on a scale | Standard Deviation 0.82 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: A | 6.7 units on a scale | Standard Deviation 0.58 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: B | 6.5 units on a scale | Standard Deviation 1.07 |
| Tabalumab Prefilled Syringe | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: C | 6.6 units on a scale | Standard Deviation 0.86 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: I | 6.9 units on a scale | Standard Deviation 0.39 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: B | 6.9 units on a scale | Standard Deviation 0.28 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: D | 6.9 units on a scale | Standard Deviation 0.31 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: J | 6.8 units on a scale | Standard Deviation 0.47 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: E | 6.8 units on a scale | Standard Deviation 0.74 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: G | 6.5 units on a scale | Standard Deviation 1.05 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: F | 6.8 units on a scale | Standard Deviation 0.74 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: K | 6.9 units on a scale | Standard Deviation 0.4 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: G | 6.6 units on a scale | Standard Deviation 1.06 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: K | 6.8 units on a scale | Standard Deviation 0.65 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: H | 6.8 units on a scale | Standard Deviation 0.68 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: L | 6.8 units on a scale | Standard Deviation 0.51 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: I | 6.9 units on a scale | Standard Deviation 0.67 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: H | 6.8 units on a scale | Standard Deviation 0.64 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: J | 6.8 units on a scale | Standard Deviation 0.74 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: A | 6.8 units on a scale | Standard Deviation 0.71 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: K | 6.9 units on a scale | Standard Deviation 0.67 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: A | 6.9 units on a scale | Standard Deviation 0.3 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: L | 6.8 units on a scale | Standard Deviation 0.72 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: B | 6.8 units on a scale | Standard Deviation 0.64 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: A | 6.8 units on a scale | Standard Deviation 0.6 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: I | 6.8 units on a scale | Standard Deviation 0.7 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: B | 6.8 units on a scale | Standard Deviation 0.6 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: C | 6.8 units on a scale | Standard Deviation 0.71 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: C | 6.8 units on a scale | Standard Deviation 0.55 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: L | 6.8 units on a scale | Standard Deviation 0.77 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: D | 6.8 units on a scale | Standard Deviation 0.45 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: D | 6.8 units on a scale | Standard Deviation 0.73 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: E | 6.7 units on a scale | Standard Deviation 0.56 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: J | 6.7 units on a scale | Standard Deviation 0.78 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: F | 6.7 units on a scale | Standard Deviation 0.7 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: E | 6.7 units on a scale | Standard Deviation 0.76 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: G | 6.5 units on a scale | Standard Deviation 0.74 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 8: C | 6.9 units on a scale | Standard Deviation 0.37 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 0: H | 6.9 units on a scale | Standard Deviation 0.35 |
| Tabalumab Auto-Injector | Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score | Week 4: F | 6.8 units on a scale | Standard Deviation 0.73 |