NCT04171414

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2020

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

November 17, 2021

Completed
Last Updated

November 17, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

September 18, 2019

Results QC Date

August 16, 2021

Last Update Submit

October 19, 2021

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • 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

  • 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

Study Arms (1)

"CT-P17 SC AI (adalimumab)"

EXPERIMENTAL

CT-P17 Subcutaneous(SC) Autoinjector(AI) (adalimumab)

Biological: CT-P17 SC AI (adalimumab)

Interventions

CT-P17 SC AI (adalimumab)BIOLOGICAL

Subcutaneous Injection of Adalimumab 40mg once every two weeks

"CT-P17 SC AI (adalimumab)"

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, Poland

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
JiWoong Lim
Organization
Celltrion Inc.
jiwoong.lim@celltrion.com
032-850-5806

Study Officials

  • MinJi Ma

    Celltrion, Inc.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2019

First Posted

November 20, 2019

Study Start

September 9, 2019

Primary Completion

November 4, 2019

Study Completion

April 24, 2020

Last Updated

November 17, 2021

Results First Posted

November 17, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)