Treating patients with infliximab based on their trough levels

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2011-002061-38-BE
• Date of registration: 08/06/2011
• Prospective Registration: Yes
• Primary sponsor: Katholieke Universiteit Leuven
• Public title: Treating patients with infliximab based on their trough levels
• Scientific title: A randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT). - TAXIT
• Date of first enrolment: 29/06/2011
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002061-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: different treatment schedule (control group: according to standard clinical practice) Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium

Contacts

• Name: Lab. for Pharmaceutical Biology
• Affiliation: Katholieke Universiteit Leuven

• Name: Lab. for Pharmaceutical Biology
• Affiliation: Katholieke Universiteit Leuven

Key inclusion & exclusion 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:
- 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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

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).

Primary end point(s): Proportion of patients in clinical and biological (CRP<5mg/l) remission in both treatment groups.

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.

Timepoint(s) of evaluation of this end point: At month 12.

Secondary Outcome(s)

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.

Secondary ID(s)

S53299

Source(s) of Monetary Support

Katholieke Universiteit Leuven