Phase 3
Completed N=62
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT04171414 ↗Enrolled (actual)
62
Serious AEs
4.8%
Results posted
Nov 2021
Primary outcomePrimary: The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4 — 8.00; 8.16; 6.55; 7.07 scores on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Clinical trial to evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4 |
8.00; 8.16; 6.55; 7.07; 8.39; 9.59 | — |
| SECONDARY Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24 |
8.88; 8.97; 7.21; 7.44; 9.04; 9.60 | — |
| SECONDARY Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24 |
62; 62; 62; 62; 62; 62 | — |
| SECONDARY Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR) |
5.248; -2.560; -2.795; -3.111; 6.190; -3.287 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04171414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.