Clinical Trial Results:
A Single-arm, Open-label, Multiple-dose, Phase 3 Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients with Moderate to Severe Active Rheumatoid Arthritis
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Summary
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EudraCT number |
2022-002928-12 |
Trial protocol |
PL |
Global end of trial date |
19 Jul 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Aug 2024
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First version publication date |
24 Aug 2024
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CT-P47 3.2
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05725434 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
CELLTRION, Inc.
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Sponsor organisation address |
23, Acedemy-ro, Yeonsu-Gu, Incheon, Korea, Republic of, 22014
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Public contact |
Clinical Operation 2 Department, CELLTRION, Inc., +82 32 850 5782, yeajin.park@celltrion.com
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Scientific contact |
Clinical Planning 3 Department, CELLTRION, Inc., +82 32 850 4167, jeehye.suh@celltrion.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Jul 2023
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Jul 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate usability of AI assessed by patient (POST-self-injection assessment questionnaire [SIAQ]) at Week 2
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Protection of trial subjects |
For hypersensitivity monitoring, vital signs (including systolic and diastolic BP, heart rate, respiratory rate, and body temperature) will be monitored prior to the study drug injection (within 15 minutes) and at 1 hour (±15 minutes) after the study drug injection. In addition, any type of ECG will be performed for hypersensitivity monitoring 1 hour (±15 minutes) after the study drug injection. Emergency equipment, such as adrenaline, antihistamines, corticosteroids, and respiratory support including inhalational therapy, oxygen, and artificial ventilator will be available.
For patients who experienced anaphylaxis or other serious treatment-related hypersensitivity reaction, study drug must be stopped immediately and discontinue study drug. If patients develop laboratory abnormalities in liver enzyme (ALT and/or AST), ANC, or platelet, or develops a serious infection, an opportunistic infection, or sepsis, the dose of concomitant DMARDs should be modified or dosing stopped and/or study drug (CT-P47) dosing regimen modified until the clinical situation has been evaluated and controlled.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Feb 2023
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 33
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Worldwide total number of subjects |
33
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EEA total number of subjects |
33
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
30
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
First patient enrolled: 27 February 2023. This study was conducted at 3 study centers in Poland. | ||||||||||||||
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Pre-assignment
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Screening details |
Male or female patients with moderate to severe active RA diagnosed according to the 2010 ACR/EULAR classification criteria for at least 24 weeks, who have inadequate response to one or more DMARDs, who had been receiving MTX for at least 12 weeks on a stable dose and route of 10 to 25 mg/week for at least 8 weeks prior administration. | ||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
33 | ||||||||||||||
Number of subjects completed |
33 | ||||||||||||||
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Period 1
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Period 1 title |
Treatment Period (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||
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Arms
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Arm title
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CT-P47 | ||||||||||||||
Arm description |
CT-P47 (162mg/0.9mL) was administered by SC injection via AI at Week 0, Week 2 and then PFS EOW or weekly based on clinical response by investigator’s discretion from Week 4 up to Week 10, in combination with MTX and folic acid. The dosing frequency may be increased to weekly based on clinical response by investigator’s discretion. | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
CT-P47
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection in pre-filled pen
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Routes of administration |
Solution for injection
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Dosage and administration details |
A fixed dose of the study drug (162 mg) was administered EOW. Co-administered with MTX; 10 to 25 mg/week and folic acid (≥5 mg/week).
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Baseline characteristics reporting groups
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Reporting group title |
CT-P47
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Reporting group description |
CT-P47 (162mg/0.9mL) was administered by SC injection via AI at Week 0, Week 2 and then PFS EOW or weekly based on clinical response by investigator’s discretion from Week 4 up to Week 10, in combination with MTX and folic acid. The dosing frequency may be increased to weekly based on clinical response by investigator’s discretion. | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
CT-P47
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Reporting group description |
CT-P47 (162mg/0.9mL) was administered by SC injection via AI at Week 0, Week 2 and then PFS EOW or weekly based on clinical response by investigator’s discretion from Week 4 up to Week 10, in combination with MTX and folic acid. The dosing frequency may be increased to weekly based on clinical response by investigator’s discretion. | ||
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End point title |
The Usability of AI as Assessed by Patients Rating Using POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 2. [1] | ||||||||||||||||||||
End point description |
Usability was assessed using the SIAQ prior to and after self-injection of CT-P47 via AI at Week 0 and 2. The PRE module of the SIAQ is a 7-item questionnaire that investigates 3 domains such as feelings about injections, selfconfidence (regarding self-administration), and satisfaction with self-injection. The POST module of the SIAQ is a 27-item questionnaire that assesses 6 domains such as feelings about injection, self-image, self-confidence (regarding self-administration), pain and skin reactions during or after the injection (injection-site reactions), ease of use of the selfinjection device (AI), and satisfaction with self-injection. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item.
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End point type |
Primary
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End point timeframe |
Week 2
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis have been conducted since it is an open-label study to evaluate patient usability of the device as a primary endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Patients Rating Using PRE-SIAQ and POST-SIAQ at Week 0 | ||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Week 0
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Patients Rating Using PRE-SIAQ at Week 2 | ||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Week 2
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Successful Self-injection Rate and the Self-injection Assessments (N1 to N14) | ||||||||||||||
End point description |
Patient’s ability to successfully follow the steps in the printed instruction for use to self-administer the study drug was assessed using the self-injection assessment checklist. The self-injection assessment was coded as successful if N7, N9, N10 and N11 of the self-injection assessment checklist were checked as “Yes”. In addition, the successful completion of all 14 instructions will be assessed from the
self-injection assessment checklist. The summary table displayed the number and percentage of patient’s successful self-injection and patient’s successful completion of all 14 instructions. All answers for checklists were listed along with whether the self-injection was successful, and all instructions were completed.
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End point type |
Secondary
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End point timeframe |
Weeks 0 and 2
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Mean Change From Baseline in DAS28 (CRP and ESR) | ||||||||||||||||||||||||
End point description |
DAS28 (ESR) was calculated using the following formula: DAS28 (ESR) = 0.56 X SQRT(TJC28) + 0.28 X SQRT(SJC28) + 0.70 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.
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.
Abbreviations: CRP, C-reactive protein; DAS28, Disease Activity Score using 28 joint counts; ESR, Erythrocyte sedimentation rate; GH, patient’s global disease activity measured on 100 mm VAS; VAS, visual analogue scale.
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End point type |
Secondary
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End point timeframe |
Weeks 2, 4, 8 and 12 (EOS)
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| Notes [2] - Number Analyzed: Week 2: 32 Week 4: 30 Week 8: 29 Week 12(EOS): 29 |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From the date the ICF is signed until the EOS or EW visit (up to Week 12)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.0
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Reporting groups
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Reporting group title |
CT-P47
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Reporting group description |
CT-P47 (162mg/0.9mL) was administered by SC injection via AI at Week 0, Week 2 and then PFS EOW or weekly based on clinical response by investigator’s discretion from Week 4 up to Week 10, in combination with MTX and folic acid. The dosing frequency may be increased to weekly based on clinical response by investigator’s discretion. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 3% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
