Precision Dosing of Infliximab Versus Conventional Dosing of Infliximab (PRECISION)
|ClinicalTrials.gov Identifier: NCT02453776|
Recruitment Status : Unknown
Verified January 2016 by M. Lowenberg, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was: Recruiting
First Posted : May 27, 2015
Last Update Posted : January 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease||Drug: PRECISION dosing Infliximab||Phase 4|
Aim of this study is to investigate the efficacy of "precision dosing" IFX maintenance treatment in comparison with standard IFX maintenance treatment in IBD patients in clinical remission.
This study will be an open, randomized, controlled trial. Inclusion criteria: Patients aged ≥18 years with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) based on endoscopy and pathology, receiving scheduled IFX therapy for ≥14 weeks, in clinical remission based on a Harvey Bradshaw Index (HBI) score ≤4 or a Partial Mayo (PM) score ≤2, for CD and UC, respectively. Exclusion criteria: Dilatation or resectional surgury in the past year and patients with a stoma/pouch.
Patients in the intervention arm will receive individualized treatment with variable IFX dosing AND/OR intervals guided by a Bayesian pharmacokinetic model, aiming to achieve an IFX TL of 3 µg/ml. Patients in the control group will continue to receive the same IFX treatment regimen that was given prior to inclusion without dose adaptation. In the control group, treatment adjustments will only be made in case of signs of active disease, in accordance to current routine care but these patients will be considered as failures to their treatment.
Primary endpoint: Proportion of patients with sustained clinical remission (based on HBI or PM). Secondary endpoints include: annual costs of IFX treatment per patient, total annual medical costs, side effects, (sustained) biochemical remission, adverse events, quality of life, IFX trough level and IFX antibodies (with an assay allowing presence of drug).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation will result in additional blood sampling, since IFX serum concentration will be measured every 8 weeks. All other laboratory tests can be considered as routine care. Patients in the intervention group with IFX TLs >3 will receive treatment de-escalation (interval elongation and/or dose reduction) as indicated by the Baysian model. Current evidence indicates that an IFX TL of 3 suffices. Patients in the intervention group with TLs <3 will receive treatment escalation (interval shortening and/or dose increase). We hypothesize that this will result in a higher chance of remaining in clinical remission.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Precision Dosing Versus Conventional Dosing of Infliximab Maintenance Therapy: a Randomized Controlled Multicenter Study in Patients With IBD in Clinical Remission|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2017|
Experimental: PRECISION dosing
Infliximab may vary between 1-10 mg/kg and the interval between 4 and 12 weeks.
Drug: PRECISION dosing Infliximab
Patients in the PRECISION dosing arm will recieve model based dosing, whereas proactive adjustments in treatment can be made by measuring the Infliximab concentration.
No Intervention: Conventional dosing of Infliximab
Infliximab 5 mg/kg every 8 or 6 weeks
- Sustained clinical remission for the precision dosing group vs. the conventional IFX maintenance dosing group [ Time Frame: 52 weeks ]Sustained clinical remission based on HBI (Crohn's disease) or PM score (Ulcerative Colitis)
- Cost of IFX treatment between the two groups [ Time Frame: 52 weeks ]Comparing costs for treatment with IFX between the two groups
- Proportion of patients with antibodies against IFX [ Time Frame: 52 weeks ]
- Quality of life [ Time Frame: 52 weeks ]With a QoL questionnaire
- Biochemical disease activity (CRP >5mg/L and fecal calprotectin ≥50% compared to baseline, to a value of >250 ug/g) [ Time Frame: 26 weeks, 52 weeks ]A rise in fecal calprotectin of ≥50% compared to baseline, to a value of >250 ug/g and/or serum CRP of >5mg/L
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453776
|Contact: Anne S Strik, email@example.com|
|Contact: M Lowenberg, firstname.lastname@example.org|
|Academic Medical Center||Recruiting|
|Amsterdam, Noord-Holland, Netherlands, 1102 AZ|
|Contact: Anne S Strik, drs email@example.com|
|Contact: Mark Lowenberg, dr firstname.lastname@example.org|
|Study Director:||G D'Haens||Professor gastroenterology|