Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-007519-34-SE

Enrollment

Registered

2009-03-02

Start date

2009-04-17

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

This is a open label, prospective, multicenter trial in patients recieving one hour infusions of infliximab (i.e. Remicade)as part of their daily practice. Main objective: Is to assess the tolerability of Remicade with an infusionsrate of 30 minutes. Patients: eligible patients are those with intestinal fistulas Mb Crohn disease or Ulcerative colitis/IBD. or patietns with

Interventions

Trade Name: Remicade Pharmaceutical Form: Powder and solvent for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients age 18-80 years Mb Crohn disease or Ulcerative colitis or IBD Already on infliximab therapy treated with one hour infusion sustained clinical respone to infliximab 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 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Documentation of suspected immediated or delayed infusion reaction to previous infliximab infusion. Prophylactic therapy before infliximab infusion to prevent infusion reaction including corticosteroids, antihistamines and acetaminophen. Need for dose increase or decrease of interval below 6 weeks for loss of response Dosing interval longer than 12 weeks in the previous 12 months Known allergic reactions to any theraputic protein or to murine proteins Any other contraindication to infliximabtherapy at the time of screening

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the tolerability and safety of 30 minutes Infliximab infusion;Secondary Objective: Proportion of patients with minor infusions reactions Incidence and timing of seroius adverse events Efficiacy of infliximab as defined as the proportion of patients interrupting therapy due to side effects or loss of response Patients and nurses preference ;Primary end point(s): The proportion of patients with IBD who tolerates Infliximab infusions during 30 minutes	—

Measure

Time frame

Main Objective: To assess the tolerability and safety of 30 minutes Infliximab infusion;Secondary Objective: Proportion of patients with minor infusions reactions Incidence and timing of seroius adverse events Efficiacy of infliximab as defined as the proportion of patients interrupting therapy due to side effects or loss of response Patients and nurses preference ;Primary end point(s): The proportion of patients with IBD who tolerates Infliximab infusions during 30 minutes

—

Countries

Sweden

Outcome results

None listed

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