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Non-interventional Study (NIS) to provide Information about Infliximab-Pen for Subcutaneous Infliximab Application (product: Remsima® 120 mg)

Non-interventional Study (NIS) to provide Information about Infliximab-Pen for Subcutaneous Infliximab Application (product: Remsima® 120 mg)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00022457
Enrollment
500
Registered
2020-07-17
Start date
2020-09-28
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis

Interventions

Group 1: Treatment with Remsima®-Pen

Sponsors

Celltrion Healthcare Deutschland GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Signed informed consent (data protection) - Male and female outpatient aged =18 years with the further need of treatment of rheumatoid arthritis (RA), ankylosing spondylitis (AS) or psoriatic arthritis (PsA) - Experience with Remsima®-Pen for at least 3 self-injections at first or later re-visit of patient after hand-over of the Remsima®-Pen at the physician site

Exclusion criteria

Exclusion criteria: - Patient <18 years (children and adolescents) - Patient who exhibit contraindications according to SPC (Summary of Product Characteristics) for Remsima® 120 mg or hypersensitivity to any of the ingredients of Remsima® 120 mg is known and therefore treatment with Remsima® 120 mg is not indicated

Design outcomes

Primary

MeasureTime frame
The primary endpoint is defined as percentage of participants that are either "very satisfied (score = 4)" or "satisfied (score = 3)" with the Remsima®-Pen. Single survey.

Secondary

MeasureTime frame
- Percentage of patients that are either "very satisfied" or “satisfied” with quality and understandabilitly of the training materials of the Remsima®-Pen. - Personal experience with the Remsima®-Pen using a patient questionnaire. Single survey.

Countries

Germany

Contacts

Public ContactKirsten Guntermann

Celltrion Healthcare Deutschland GmbH

medinfoDE@celltrionhc.com030 346494150

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026