on-interventional Study (NIS) to provide Information about Infliximab-Pen for Subcutaneous Infliximab Application (product: Remsima® 120 mg)
- Conditions
- Rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis
- Registration Number
- DRKS00022457
- Lead Sponsor
- Celltrion Healthcare Deutschland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 81
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
- 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - Percentage of patients that are either very satisfied or satisfied” with quality and understandabilitly of the training materials of the Remsima®-Pen.<br>- Personal experience with the Remsima®-Pen using a patient questionnaire. Single survey.