Trial Outcomes & Findings for A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an Autoinjector (NCT NCT02124798)
NCT ID: NCT02124798
Last Updated: 2018-04-11
Results Overview
The primary objective was to assess the suitability of the auto injector for self-administration of belimumab. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included.
COMPLETED
PHASE2
95 participants
Weeks 1 and 2 (Inside clinic)
2018-04-11
Participant Flow
This was a study in participants with Systemic Lupus Erythematosus (SLE). The study was conducted at 27 centers in the United States from 20 May 2014 to 13 April 2015.
A total of 119 participants were screened out of which only 95 were enrolled to the study treatment. 25 were screen failures the reasons for which were did not meet inclusion/exclusion criteria (23), lost to follow up (1), withdrew consent (1).
Participant milestones
| Measure |
Total
Eligible participants self administered once weekly dose of 200 milligram per milliliter (mg/mL), of belimumab subcutaneously (SC) into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
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|---|---|
|
Overall Study
STARTED
|
95
|
|
Overall Study
COMPLETED
|
91
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Total
Eligible participants self administered once weekly dose of 200 milligram per milliliter (mg/mL), of belimumab subcutaneously (SC) into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
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|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an Autoinjector
Baseline characteristics by cohort
| Measure |
Belimumab 200mg Auto Injector
n=95 Participants
Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
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|---|---|
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Age, Continuous
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44.8 Years
STANDARD_DEVIATION 12.50 • n=93 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Weeks 1 and 2 (Inside clinic)Population: The intention-to-treat (ITT) population was defined as all participants who were enrolled and treated with at least 1 dose of belimumab. Only those participants with data available at the indicated time points were analyzed.
The primary objective was to assess the suitability of the auto injector for self-administration of belimumab. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included.
Outcome measures
| Measure |
Belimumab 200mg Auto Injector
n=90 Participants
Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
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|---|---|
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Number of Participants Successfully Able to Self-administer Their Observed First and Second Doses in Weeks 1 and 2 (Inside Clinic)
Week 1 and 2, YES
|
89 Participants
|
|
Number of Participants Successfully Able to Self-administer Their Observed First and Second Doses in Weeks 1 and 2 (Inside Clinic)
Week 1 and 2, NO
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 4 and 8 (Inside clinic)Population: ITT population. Only those participants with data available at the indicated time points were analyzed.
The main objective was to assess the suitability of the auto injector for self-administration of belimumab by participants with SLE. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included.
Outcome measures
| Measure |
Belimumab 200mg Auto Injector
n=87 Participants
Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
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|---|---|
|
Number of Participants Successfully Able to Self-administer Their Observed Doses in Weeks 4 and 8 (Inside Clinic)
Week 4 and 8, YES
|
85 Participants
|
|
Number of Participants Successfully Able to Self-administer Their Observed Doses in Weeks 4 and 8 (Inside Clinic)
Week 4 and 8, NO
|
2 Participants
|
SECONDARY outcome
Timeframe: Weeks 3, 5, 6, and 7 (Outside clinic)Population: ITT population. Only those participants with data available at the indicated time points were analyzed.
Assessment was performed for suitability of the auto injector for self-administration of belimumab by participant with SLE outside the clinic setting. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections outside of the clinic without assistance were included.
Outcome measures
| Measure |
Belimumab 200mg Auto Injector
n=87 Participants
Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
|
|---|---|
|
Number of Participants Who Reported They Were Successfully Able to Self-administer Their Doses Outside the Clinic Setting in Weeks 3, 5, 6, and 7 (Outside Clinic)
Weeks 3, 5, 6 and 7, YES
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81 Participants
|
|
Number of Participants Who Reported They Were Successfully Able to Self-administer Their Doses Outside the Clinic Setting in Weeks 3, 5, 6, and 7 (Outside Clinic)
Weeks 3, 5, 6 and 7, NO
|
6 Participants
|
Adverse Events
Belimumab 200mg Auto Injector
Serious adverse events
| Measure |
Belimumab 200mg Auto Injector
n=95 participants at risk
Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
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|---|---|
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Blood and lymphatic system disorders
Anaemia
|
1.1%
1/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
1/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Infections and infestations
Pneumonia
|
1.1%
1/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Infections and infestations
Postoperative abscess
|
1.1%
1/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
General disorders
Pyrexia
|
1.1%
1/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
1/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Vascular disorders
Deep vein thrombosis
|
1.1%
1/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
Other adverse events
| Measure |
Belimumab 200mg Auto Injector
n=95 participants at risk
Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
|
|---|---|
|
Infections and infestations
Bronchitis
|
3.2%
3/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Infections and infestations
Sinusitis
|
3.2%
3/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Infections and infestations
Gastroenteritis viral
|
2.1%
2/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Infections and infestations
Herpes zoster
|
2.1%
2/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
2/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
2/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Gastrointestinal disorders
Nausea
|
6.3%
6/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
3/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
2/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
4/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
3.2%
3/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.1%
2/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
General disorders
Fatigue
|
2.1%
2/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
General disorders
Injection site erythema
|
2.1%
2/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
General disorders
Malaise
|
2.1%
2/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
|
Nervous system disorders
Headache
|
2.1%
2/95 • From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER