Rheumatoid ArthritisPhase 3NCT04171414

A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis

A Phase 3 study testing CT-P17 SC AI (adalimumab) in people with Rheumatoid Arthritis, run by Celltrion at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Clinical trial to evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: CT-P17 SC AI (adalimumab)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 sitePoland
Study dates: 9 Sep 2019to 24 Apr 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz

Other trials in Poland

About this study

Official title: A Phase III, Open-label, Single-arm, Multiple-dose Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Moderate to Severe Active Rheumatoid Arthritis

Clinical trial to evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis

Read the 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.

Conditions: Rheumatoid Arthritis
Being tested: CT-P17 SC AI (adalimumab)
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT-P17 SC AI (adalimumab)Biological
Subcutaneous Injection of Adalimumab 40mg once every two weeks

Study groups in NCT04171414
Study group	Role	What they receive
"CT-P17 SC AI (adalimumab)"	Experimental	CT-P17 Subcutaneous(SC) Autoinjector(AI) (adalimumab) Receives: Biological: CT-P17 SC AI (adalimumab)

What is being measured

The primary outcome is the main question the study is designed to answer.

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)]
Measured: Week 4

Secondary outcomes (5)

Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Measured: Week 0
Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24
Measured: Week 0,2,4,24
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
Measured: Week 8,16,24
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Measured: Week 2
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 201924 Apr 2020

First posted20 Nov 2019
Study start9 Sep 2019
Primary completion4 Nov 2019
Study completion24 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04171414
Sponsor's protocol ID: CT-P17 3.2
Other IDs: 2019-000660-25, 2019
Status last verified: Oct 2021
First submitted: 18 Sep 2019
Last updated: 17 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Open-label, Single-arm, Multiple-dose Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Moderate to Severe Active Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT04171414
Acronym / sponsor ID: CT-P17 3.2
Conditions: Rheumatoid Arthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: CelltrionIndustry (pharma, biotech, devices)
Collaborators: PPD Development, LP
Study start: 9 Sep 2019 (actual)
Primary completion: 4 Nov 2019 (actual)
Study completion: 24 Apr 2020 (actual)
First posted: 20 Nov 2019 (actual)
Results: Posted 17 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Clinical trial to evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
"CT-P17 SC AI (adalimumab)"	Experimental	Biological: CT-P17 SC AI (adalimumab)CT-P17 Subcutaneous(SC) Autoinjector(AI) (adalimumab)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT-P17 SC AI (adalimumab)Subcutaneous Injection of Adalimumab 40mg once every two weeks	Biological	"CT-P17 SC AI (adalimumab)"

Primary outcome

The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4
Time frame: 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)]

5 secondary outcomes

Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Time frame: Week 0
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
Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR)
Time frame: Week 8,16,24
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Time frame: Week 2
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24
Time frame: Week 24

Results and safety

Results posted to the registry on 17 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
"CT-P17 SC AI (Adalimumab)"	62	60

Primary outcome: The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4

Time frame: Week 4. Mean (Standard Deviation). Unit: scores on a scale

Measure	"CT-P17 SC AI (Adalimumab)" n = 62
Feelings about self-injections (PRE)	8.00 (2.131)
Feelings about self-injections (POST)	8.16 (2.036)
Self-confidence (PRE)	6.55 (1.859)
Self-confidence (POST)	7.07 (1.616)
Self-image (POST)	8.39 (2.079)
Pain and skin reactions during or after the injection (POST)	9.59 (0.968)
Ease of use of the self-injection device (POST)	8.70 (1.457)
Satisfaction with self-injection (PRE)	8.27 (1.669)

Population analysed: Usability and Intent-to-Treat (ITT) population.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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 reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
"CT-P17 SC AI (Adalimumab)"	3 of 62 (4.8%)	20 of 62 (32.3%)	1 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Rheumatoid Arthritis

Recruiting
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MinJi Ma study chair

Celltrion, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CT-P17 SC AI (adalimumab) in people with Rheumatoid Arthritis, run by Celltrion at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4 (time frame: Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04171414.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.