Trial Outcomes & Findings for A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis (NCT NCT04171414)
NCT ID: NCT04171414
Last Updated: 2021-11-17
Results Overview
The usability of CT-P17 Auto Injector is measured by participant using PRE- and POST-Self-injection Assessment Questionnaire (SIAQ) modules. The PRE-SIAQ module is a 7-item questionnaire and the POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence (regarding self-administration), pain and skin reactions before after injection. Participants rated each item of the SIAQ on a 5-point (or 6-point) semantic Likert-type scal. (each item graded on a 5-point scale). \[Scores were transformed to Rate between 0 (worst) to 10 (best)\]
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
62 participants
Primary outcome timeframe
Week 4
Results posted on
2021-11-17
Participant Flow
Participant milestones
| Measure |
"CT-P17 SC AI (Adalimumab)"
The CT-P17 (40mg/0.4mL) was administered every other week (EOW) by subcutaneous (SC) injection via autoinjector (AI) from Week 0 to Week 24 in combination with methotrexate (MTX) and folic acid.
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|---|---|
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Overall Study
STARTED
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62
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
"CT-P17 SC AI (Adalimumab)"
The CT-P17 (40mg/0.4mL) was administered every other week (EOW) by subcutaneous (SC) injection via autoinjector (AI) from Week 0 to Week 24 in combination with methotrexate (MTX) and folic acid.
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|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
"CT-P17 SC AI (Adalimumab)"
n=62 Participants
The CT-P17 (40mg/0.4mL) was administered every other week (EOW) by subcutaneous (SC) injection via autoinjector (AI) from Week 0 to Week 24 in combination with methotrexate (MTX) and folic acid.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
54.0 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
Poland
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62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: Usability and Intent-to-Treat (ITT) population.
The usability of CT-P17 Auto Injector is measured by participant using PRE- and POST-Self-injection Assessment Questionnaire (SIAQ) modules. The PRE-SIAQ module is a 7-item questionnaire and the POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence (regarding self-administration), pain and skin reactions before after injection. Participants rated each item of the SIAQ on a 5-point (or 6-point) semantic Likert-type scal. (each item graded on a 5-point scale). \[Scores were transformed to Rate between 0 (worst) to 10 (best)\]
Outcome measures
| Measure |
"CT-P17 SC AI (Adalimumab)"
n=62 Participants
The CT-P17 (40mg/0.4mL) was administered every other week (EOW) by subcutaneous (SC) injection via autoinjector (AI) from Week 0 to Week 24 in combination with methotrexate (MTX) and folic acid.
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|---|---|
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The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4
Ease of use of the self-injection device (POST)
|
8.70 scores on a scale
Standard Deviation 1.457
|
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The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4
Feelings about self-injections (PRE)
|
8.00 scores on a scale
Standard Deviation 2.131
|
|
The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4
Feelings about self-injections (POST)
|
8.16 scores on a scale
Standard Deviation 2.036
|
|
The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4
Self-confidence (PRE)
|
6.55 scores on a scale
Standard Deviation 1.859
|
|
The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4
Self-confidence (POST)
|
7.07 scores on a scale
Standard Deviation 1.616
|
|
The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4
Self-image (POST)
|
8.39 scores on a scale
Standard Deviation 2.079
|
|
The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4
Pain and skin reactions during or after the injection (POST)
|
9.59 scores on a scale
Standard Deviation 0.968
|
|
The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4
Satisfaction with self-injection (PRE)
|
8.27 scores on a scale
Standard Deviation 1.669
|
|
The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4
Satisfaction with self-injection (POST)
|
8.23 scores on a scale
Standard Deviation 1.191
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SECONDARY outcome
Timeframe: Week 0Population: Usability and Intent-to-Treat (ITT) population.
Outcome measures
| Measure |
"CT-P17 SC AI (Adalimumab)"
n=62 Participants
The CT-P17 (40mg/0.4mL) was administered every other week (EOW) by subcutaneous (SC) injection via autoinjector (AI) from Week 0 to Week 24 in combination with methotrexate (MTX) and folic acid.
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|---|---|
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Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Feelings about self-injections (PRE)
|
7.39 scores on a scale
Standard Deviation 2.437
|
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Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Feelings about self-injections (POST)
|
8.04 scores on a scale
Standard Deviation 2.086
|
|
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Self-confidence (PRE)
|
5.22 scores on a scale
Standard Deviation 2.272
|
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Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Self-confidence (POST)
|
6.18 scores on a scale
Standard Deviation 2.518
|
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Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Self-image (POST)
|
8.35 scores on a scale
Standard Deviation 2.306
|
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Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Pain and skin reactions during or after the injection (POST)
|
9.48 scores on a scale
Standard Deviation 1.152
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Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Ease of use of the self-injection device (POST)
|
8.40 scores on a scale
Standard Deviation 1.531
|
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Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Satisfaction with self-injection (PRE)
|
6.15 scores on a scale
Standard Deviation 1.682
|
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Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Satisfaction with self-injection (POST)
|
8.00 scores on a scale
Standard Deviation 1.250
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SECONDARY outcome
Timeframe: Week 0,2,4,24Population: Usability and Intent-to-Treat (ITT) population.
Outcome measures
| Measure |
"CT-P17 SC AI (Adalimumab)"
n=62 Participants
The CT-P17 (40mg/0.4mL) was administered every other week (EOW) by subcutaneous (SC) injection via autoinjector (AI) from Week 0 to Week 24 in combination with methotrexate (MTX) and folic acid.
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|---|---|
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Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24
Week 0, Overall Successful Self-Injection
|
62 Participants
|
|
Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24
Week 2, Successful Self-Injection
|
62 Participants
|
|
Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24
Week 2, Overall Successful Self-Injection
|
62 Participants
|
|
Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24
Week 4, Successful Self-Injection
|
62 Participants
|
|
Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24
Week 4, Overall Successful Self-Injection
|
62 Participants
|
|
Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24
Week 24, Successful Self-Injection
|
60 Participants
|
|
Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24
Week 0, Successful Self-Injection
|
62 Participants
|
|
Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24
Week 24, Overall Successful Self-Injection
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60 Participants
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SECONDARY outcome
Timeframe: Week 8,16,24Population: ITT population.
DAS28 (CRP) was calculated using the following formula: DAS28 (CRP) = 0.56 X SQRT(TJC28) + 0.28 X SQRT(SJC28) + 0.36 X ln(CRP+1) + 0.014 X GH on VAS + 0.96. DAS28 (CRP) provides a number on a scale from 0 to 10 with higher values indicating greater RA disease activity. DAS28 (ESR) was calculated using the following formula: DAS28 (CRP) = 0.56 X SQRT(TJC28) + 0.28 X SQRT(SJC28) + 0.36 X ln(ESR) + 0.014 X GH on VAS. DAS28 (ESR) provides a number on a scale from 0 to 10 with higher values indicating greater RA disease activity. Abbreviation: CRP, C-reactive protein; DAS28, Disease Activity Score using 28 joint counts; ESR, Erythrocyte sedimentation rate
Outcome measures
| Measure |
"CT-P17 SC AI (Adalimumab)"
n=62 Participants
The CT-P17 (40mg/0.4mL) was administered every other week (EOW) by subcutaneous (SC) injection via autoinjector (AI) from Week 0 to Week 24 in combination with methotrexate (MTX) and folic acid.
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|---|---|
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Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR)
CRP, Week 16, Change from baseline
|
-2.795 scores on a scale
Standard Deviation 1.2381
|
|
Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR)
CRP, Week 24, Change from baseline
|
-3.111 scores on a scale
Standard Deviation 1.1109
|
|
Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR)
ESR, Week 8, Change from baseline
|
-3.287 scores on a scale
Standard Deviation 1.3525
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Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR)
ESR, Week 16, Change from baseline
|
-3.495 scores on a scale
Standard Deviation 1.4695
|
|
Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR)
CRP, Baseline
|
5.248 scores on a scale
Standard Deviation 0.8415
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|
Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR)
CRP, Week 8, Change from baseline
|
-2.560 scores on a scale
Standard Deviation 1.1223
|
|
Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR)
ESR, Baseline
|
6.190 scores on a scale
Standard Deviation 0.7360
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Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR)
ESR, Week 24, Change from baseline
|
-3.799 scores on a scale
Standard Deviation 1.4287
|
SECONDARY outcome
Timeframe: Week 2Population: Usability and Intent-to-Treat (ITT) population.
Outcome measures
| Measure |
"CT-P17 SC AI (Adalimumab)"
n=62 Participants
The CT-P17 (40mg/0.4mL) was administered every other week (EOW) by subcutaneous (SC) injection via autoinjector (AI) from Week 0 to Week 24 in combination with methotrexate (MTX) and folic acid.
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|---|---|
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Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Satisfaction with self-injection (POST)
|
8.16 scores on a scale
Standard Deviation 1.177
|
|
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Feelings about self-injections (PRE)
|
7.93 scores on a scale
Standard Deviation 2.175
|
|
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Feelings about self-injections (POST)
|
8.08 scores on a scale
Standard Deviation 2.110
|
|
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Self-confidence (PRE)
|
6.61 scores on a scale
Standard Deviation 2.007
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|
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Self-confidence (POST)
|
6.67 scores on a scale
Standard Deviation 1.811
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|
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Self-image (POST)
|
8.27 scores on a scale
Standard Deviation 2.245
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Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Pain and skin reactions during or after the injection (POST)
|
9.64 scores on a scale
Standard Deviation 0.693
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Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Ease of use of the self-injection device (POST)
|
8.34 scores on a scale
Standard Deviation 1.698
|
|
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Satisfaction with self-injection (PRE)
|
7.78 scores on a scale
Standard Deviation 2.128
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SECONDARY outcome
Timeframe: Week 24Population: Usability and Intent-to-Treat (ITT) population.
Outcome measures
| Measure |
"CT-P17 SC AI (Adalimumab)"
n=62 Participants
The CT-P17 (40mg/0.4mL) was administered every other week (EOW) by subcutaneous (SC) injection via autoinjector (AI) from Week 0 to Week 24 in combination with methotrexate (MTX) and folic acid.
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|---|---|
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Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Feelings about self-injections (PRE)
|
8.88 scores on a scale
Standard Deviation 2.034
|
|
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Feelings about self-injections (POST)
|
8.97 scores on a scale
Standard Deviation 1.888
|
|
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Self-confidence (PRE)
|
7.21 scores on a scale
Standard Deviation 1.556
|
|
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Self-confidence (POST)
|
7.44 scores on a scale
Standard Deviation 1.840
|
|
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Self-image (POST)
|
9.04 scores on a scale
Standard Deviation 1.533
|
|
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Pain and skin reactions during or after the injection (POST)
|
9.60 scores on a scale
Standard Deviation 0.841
|
|
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Ease of use of the self-injection device (POST)
|
9.35 scores on a scale
Standard Deviation 1.057
|
|
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Satisfaction with self-injection (PRE)
|
8.83 scores on a scale
Standard Deviation 1.868
|
|
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Satisfaction with self-injection (POST)
|
8.95 scores on a scale
Standard Deviation 1.023
|
Adverse Events
"CT-P17 SC AI (Adalimumab)"
Serious events: 3 serious events
Other events: 20 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
"CT-P17 SC AI (Adalimumab)"
n=62 participants at risk
The CT-P17 (40mg/0.4mL) was administered every other week (EOW) by subcutaneous (SC) injection via autoinjector (AI) from Week 0 to Week 24 in combination with methotrexate (MTX) and folic acid.
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|---|---|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.6%
1/62 • Number of events 62 • Adverse events were assessed from the date the patient signed the ICF until EOS/ED visit. (up to week 28, including 4 weeks of follow-up period)
|
|
Infections and infestations
Tooth infection
|
1.6%
1/62 • Number of events 62 • Adverse events were assessed from the date the patient signed the ICF until EOS/ED visit. (up to week 28, including 4 weeks of follow-up period)
|
|
Reproductive system and breast disorders
Cervical polyp
|
1.6%
1/62 • Number of events 62 • Adverse events were assessed from the date the patient signed the ICF until EOS/ED visit. (up to week 28, including 4 weeks of follow-up period)
|
Other adverse events
| Measure |
"CT-P17 SC AI (Adalimumab)"
n=62 participants at risk
The CT-P17 (40mg/0.4mL) was administered every other week (EOW) by subcutaneous (SC) injection via autoinjector (AI) from Week 0 to Week 24 in combination with methotrexate (MTX) and folic acid.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
21.0%
13/62 • Number of events 62 • Adverse events were assessed from the date the patient signed the ICF until EOS/ED visit. (up to week 28, including 4 weeks of follow-up period)
|
|
Infections and infestations
Urinary tract infection
|
4.8%
3/62 • Number of events 62 • Adverse events were assessed from the date the patient signed the ICF until EOS/ED visit. (up to week 28, including 4 weeks of follow-up period)
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
2/62 • Number of events 62 • Adverse events were assessed from the date the patient signed the ICF until EOS/ED visit. (up to week 28, including 4 weeks of follow-up period)
|
|
Nervous system disorders
Headache
|
3.2%
2/62 • Number of events 62 • Adverse events were assessed from the date the patient signed the ICF until EOS/ED visit. (up to week 28, including 4 weeks of follow-up period)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.2%
2/62 • Number of events 62 • Adverse events were assessed from the date the patient signed the ICF until EOS/ED visit. (up to week 28, including 4 weeks of follow-up period)
|
|
General disorders
Influenza like illness
|
3.2%
2/62 • Number of events 62 • Adverse events were assessed from the date the patient signed the ICF until EOS/ED visit. (up to week 28, including 4 weeks of follow-up period)
|
|
General disorders
Injection site reaction
|
3.2%
2/62 • Number of events 62 • Adverse events were assessed from the date the patient signed the ICF until EOS/ED visit. (up to week 28, including 4 weeks of follow-up period)
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
2/62 • Number of events 62 • Adverse events were assessed from the date the patient signed the ICF until EOS/ED visit. (up to week 28, including 4 weeks of follow-up period)
|
|
Infections and infestations
Pharyngitis
|
3.2%
2/62 • Number of events 62 • Adverse events were assessed from the date the patient signed the ICF until EOS/ED visit. (up to week 28, including 4 weeks of follow-up period)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER