Rheumatoid Arthritis
Conditions
Brief summary
Clinical trial to evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
Detailed description
CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to Humira. The purpose of this study is to evaluate usability of subcutaneous auto-injector of CT-P17 in patients with moderate to severe rheumatoid arthritis.
Interventions
BIOLOGICALCT-P17 SC AI (adalimumab)
Subcutaneous Injection of Adalimumab 40mg once every two weeks
Sponsors
PPD Development, LP
Celltrion
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patient aged 18 to 70 years, inclusive. * Patient must be able and willing to self-administer subcutaneous (SC) injections via auto injector (AI).
Exclusion criteria
* Patient who has previously received investigational or licensed product; biologic or targeted synthetic disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any purposes. * Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4 | Week 4 | 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). \[Scores were transformed to Rate between 0 (worst) to 10 (best)\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24 | Week 0 | — |
| Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24 | Week 0,2,4,24 | — |
| Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR) | Week 8,16,24 | 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 |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | CT-P17 SC AI (Adalimumab) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants |
| Age, Continuous | 54.0 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 62 Participants |
| Region of Enrollment Poland | 62 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 62 |
| other Total, other adverse events | 20 / 62 |
| serious Total, serious adverse events | 3 / 62 |
Outcome results
Primary
The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4
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). \[Scores were transformed to Rate between 0 (worst) to 10 (best)\]
Time frame: Week 4
Population: Usability and Intent-to-Treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
Secondary
Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR)
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
Time frame: Week 8,16,24
Population: ITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CT-P17 SC AI (Adalimumab) | Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR) | ESR, Baseline | 6.190 scores on a scale | Standard Deviation 0.736 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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
Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24
Time frame: Week 0,2,4,24
Population: Usability and Intent-to-Treat (ITT) population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 | 60 Participants |
Secondary
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Time frame: Week 0
Population: Usability and Intent-to-Treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 1.25 |
Secondary
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Time frame: Week 24
Population: Usability and Intent-to-Treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 1.84 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
Secondary
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Time frame: Week 2
Population: Usability and Intent-to-Treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 2.11 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |
| CT-P17 SC AI (Adalimumab) | 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 |