Treating patients with infliximab based on their trough levels

A randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT). - TAXIT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002061-38-BE

Enrollment

Unknown

Registered

2011-06-08

Start date

2011-06-29

Completion date

Unknown

Last updated

2017-08-21

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

Conditions

2) Crohn's disease and ulcerative colitis MedDRA version: 13.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Remicade Product Name: Remicade Product Code: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Males and females = 18 and = 64 years of age - Diagnosis of CD or UC confirmed by endoscopy and histology and in stable clinical remission - Signed informed consent - On anti-TNF infliximab maintenance therapy for at least 14 consecutive weeks Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Not willing to participate in study or not willing to sign inform consent - Patients included in placebo-controlled trials - Patients not in stable remission upon entry into the study (designated by symptoms, CRP>5mg/ml and endoscopic lesions)

Design outcomes

Primary

Measure	Time frame
Main Objective: We hypothesize that in patients suffering from Crohn’s disease (CD) or ulcerative colitis (UC) under anti-tumor necrosis factor-a (anti-TNF) treatment, sustained good anti-TNF trough levels are associated with a better long term outcome (better response and remission rates, more mucosal healing and less loss of response) and will lead to a better quality of life, less disease-related surgeries and less hospitalizations. We will adapt the infliximab treatment regimen of each patient in the test group in such a way that trough levels are kept in a window between 3 and 7 µg/ml. The main objective of this study is to assess the clinical outcome of individually optimised therapy based on trough levels in the follow-up of the patients during 12 months, compared to a control group in which the treatment regimen is adapted according to standard clinical practice (i.e. clinical and biological monitoring).;Secondary Objective: Compare the proportion of patients with an infliximab trough level between 3-7µg/ml in both treatment groups after 12 months. Compare the total infliximab dose given in both treatment groups after 12 months. Compare the total cost of treatment in both treatment groups after 12 months. Compare the proportion of patients needing switch to adalimumab (Humira®) during follow up. Compare the number of infusion reactions in both treatment arms after 12 months. Compare the number of treatment adaptations in both treatment groups after 12 months. Compare the median biologic activity (CRP-levels) in both treatment groups after 12 months. Compare the number of disease flares in both treatment groups after 12 months. Compare the number of Serious Adverse Events (SAEs) in both treatment groups after 12 months.;Primary end point(s): Proportion of patients in clinical and biological (CRP<5mg/l) remission in both treatment groups.;Timepoint(s) of evaluation of this end point: At month 12.	—

Measure

Time frame

Main Objective: We hypothesize that in patients suffering from Crohn’s disease (CD) or ulcerative colitis (UC) under anti-tumor necrosis factor-a (anti-TNF) treatment, sustained good anti-TNF trough levels are associated with a better long term outcome (better response and remission rates, more mucosal healing and less loss of response) and will lead to a better quality of life, less disease-related surgeries and less hospitalizations. We will adapt the infliximab treatment regimen of each patient in the test group in such a way that trough levels are kept in a window between 3 and 7 µg/ml. The main objective of this study is to assess the clinical outcome of individually optimised therapy based on trough levels in the follow-up of the patients during 12 months, compared to a control group in which the treatment regimen is adapted according to standard clinical practice (i.e. clinical and biological monitoring).;Secondary Objective: Compare the proportion of patients with an infliximab trough level between 3-7µg/ml in both treatment groups after 12 months. Compare the total infliximab dose given in both treatment groups after 12 months. Compare the total cost of treatment in both treatment groups after 12 months. Compare the proportion of patients needing switch to adalimumab (Humira®) during follow up. Compare the number of infusion reactions in both treatment arms after 12 months. Compare the number of treatment adaptations in both treatment groups after 12 months. Compare the median biologic activity (CRP-levels) in both treatment groups after 12 months. Compare the number of disease flares in both treatment groups after 12 months. Compare the number of Serious Adverse Events (SAEs) in both treatment groups after 12 months.;Primary end point(s): Proportion of patients in clinical and biological (CRP<5mg/l) remission in both treatment groups.;Timepoint(s) of evaluation of this end point: At month 12.

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Secondary

Measure	Time frame
Secondary end point(s): The proportion of patients with an infliximab trough level between 3-7µg/ml in both treatment groups. The total infliximab dose given in both treatment groups. The total cost of treatment in both treatment groups. The proportion of patients needing switch to adalimumab (Humira®) during follow up. The number of infusion reactions in both treatment arms. The number of treatment adaptations in both treatment groups. The median biologic activity (CRP-levels) in both treatment groups. The number of disease flares in both treatment groups. The number of Serious Adverse Events (SAEs) in both treatment groups.;Timepoint(s) of evaluation of this end point: At month 12.	—

Measure

Time frame

Secondary end point(s): The proportion of patients with an infliximab trough level between 3-7µg/ml in both treatment groups. The total infliximab dose given in both treatment groups. The total cost of treatment in both treatment groups. The proportion of patients needing switch to adalimumab (Humira®) during follow up. The number of infusion reactions in both treatment arms. The number of treatment adaptations in both treatment groups. The median biologic activity (CRP-levels) in both treatment groups. The number of disease flares in both treatment groups. The number of Serious Adverse Events (SAEs) in both treatment groups.;Timepoint(s) of evaluation of this end point: At month 12.

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Countries

Belgium

Contacts

Public ContactLab. for Pharmaceutical Biology

Katholieke Universiteit Leuven

niels.vandecasteele@pharm.kuleuven.be3216323434

Outcome results

None listed

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