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Accelerated infliximab infusions in inflammatory bowel disease

Accelerated infliximab infusions in inflammatory bowel disease, Phase IV trial - Accelerated IFX infusions in IBD

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2021-000570-28-FI
Enrollment
130
Registered
2021-04-22
Start date
2021-11-09
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

Inflammatory bowel diseases

Interventions

Trade Name: Zessly, Remsima, Remicade Product Name: infliximab Pharmaceutical Form: Infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3

Sponsors

Tampere University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: IBD-patients who have received infliximab infusion ten times without infusion reactions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Less than 18 year old children and adolescents

Design outcomes

Primary

MeasureTime frame
Main Objective: Do accelerated infliximab infusions increase infusion reactions compared to standard infusions;Secondary Objective: 1) Does premedication prevent infusion reactions 2) does immunomodulative medication reduce infusion reactions ;Primary end point(s): Accelereted infusions do not increase infusion reactions;Timepoint(s) of evaluation of this end point: At the end of the study

Secondary

MeasureTime frame
Secondary end point(s): No secondary endpoints;Timepoint(s) of evaluation of this end point: No secondary endpoints

Countries

Finland

Contacts

Public ContactTampere University Hospital

Tampere University Hospital

3583311611

Outcome results

None listed

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