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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000660-25 | EudraCT Number |
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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
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Clinical trial to evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "CT-P17 SC AI (adalimumab)" | Experimental | CT-P17 Subcutaneous(SC) Autoinjector(AI) (adalimumab) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P17 SC AI (adalimumab) | Biological | Subcutaneous Injection of Adalimumab 40mg once every two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)] | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MinJi Ma | Celltrion, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nasz Lekarz Osrodek Badan Klinicznych | Bydgoszcz | Poland |
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| ID | Title | Description |
|---|---|---|
| FG000 | "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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | "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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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)] | Usability and Intent-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | scores on a scale | Week 4 |
|
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)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | "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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| JiWoong Lim | Celltrion Inc. | 032-850-5806 | jiwoong.lim@celltrion.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 11, 2019 | Aug 8, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2020 | Aug 6, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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 | Week 8,16,24 |
| Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24 | Week 2 |
| Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24 | Week 24 |
| Participants |
|
| Age, Continuous | Median | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24 | Usability and Intent-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | scores on a scale | Week 0 |
|
|
|
| Secondary | Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24 | Usability and Intent-to-Treat (ITT) population. | Posted | Count of Participants | Participants | Week 0,2,4,24 |
|
|
|
| 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 | ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Week 8,16,24 |
|
|
|
| Secondary | Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24 | Usability and Intent-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | scores on a scale | Week 2 |
|
|
|
| Secondary | Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24 | Usability and Intent-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | scores on a scale | Week 24 |
|
|
|
| 1 |
| 62 |
| 3 |
| 62 |
| 20 |
| 62 |
| Tooth infection | Infections and infestations | Systematic Assessment |
|
| Cervical polyp | Reproductive system and breast disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | Systematic Assessment |
|
| Influenza like illness | General disorders | Systematic Assessment |
|
| Injection site reaction | General disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | Systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
| Self-confidence (POST) |
|
| Self-image (POST) |
|
| Pain and skin reactions during or after the injection (POST) |
|
| Ease of use of the self-injection device (POST) |
|
| Satisfaction with self-injection (PRE) |
|
| Satisfaction with self-injection (POST) |
|
| Title | Measurements |
|---|
|
| Week 2, Overall Successful Self-Injection |
|
| Week 4, Successful Self-Injection |
|
| Week 4, Overall Successful Self-Injection |
|
| Week 24, Successful Self-Injection |
|
| Week 24, Overall Successful Self-Injection |
|
| Title | Measurements |
|---|---|
|
| CRP, Week 24, Change from baseline |
|
| ESR, Baseline |
|
| ESR, Week 8, Change from baseline |
|
| ESR, Week 16, Change from baseline |
|
| ESR, Week 24, Change from baseline |
|
|
| Self-confidence (POST) |
|
| Self-image (POST) |
|
| Pain and skin reactions during or after the injection (POST) |
|
| Ease of use of the self-injection device (POST) |
|
| Satisfaction with self-injection (PRE) |
|
| Satisfaction with self-injection (POST) |
|
|
| Self-confidence (POST) |
|
| Self-image (POST) |
|
| Pain and skin reactions during or after the injection (POST) |
|
| Ease of use of the self-injection device (POST) |
|
| Satisfaction with self-injection (PRE) |
|
| Satisfaction with self-injection (POST) |
|