search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Dose reduction of infliximab in Crohn's disease, based on serum infliximab concentration.


- candidate number14691
- NTR NumberNTR3943
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-apr-2013
- Secondary IDsNL44504.018.13 CCMO
- Public TitleDose reduction of infliximab in Crohn's disease, based on serum infliximab concentration.
- Scientific TitleCost-effectiveness of trough level-based dose reduction during infliximab maintenance treatment in Crohn's disease.
- ACRONYMREDIX
- hypothesisThe per patient annual cost of IFX maintenance treatment can be lowered in CD patients in stable remission using dose reduction of IFX guided by serial TL measurements.
- Healt Condition(s) or Problem(s) studiedCrohn's disease
- Inclusion criteria1. Diagnosis of CD based on endoscopy and pathology;
2. 18 years or older;
3. At least 6 months in remission, defined as:
A. Crohn's Disease Activity Index (CDAI) <150;
B. Normal serum C-reactive protein (CRP) level (< 5 mg/l), and;
C. Low fecal calprotectin level (< 250 ug/g).
4. IFX therapy > 6 months at 5 mg/kg every 8 weeks with or without concomitant immunosuppression (stable for > 3 months);
5. IFX TL > 7 ug/ml.
- Exclusion criteria1. Non-adherence to the 8 weekly infusions schedule in the past;
2. Participation in another therapeutic trial;
3. Pregnancy;
4. Prior dose adjustments or interval shortening of IFX.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2013
- planned closingdate1-jun-2016
- Target number of participants180
- InterventionsPatients in the intervention arm will undergo stepwise dose reduction of IFX. IFX dose will be decreased by 1 mg/kg per step. The dose will be reduced every 16 weeks, as long as the following criteria are met: CDAl < 150, CRP < 5 and fecal calprotectin < 250 on the day of the visit AND IFX TL > 3 prior to the latest two infusions.

Patients in the control arm will receive continued IFX at 5 mg/kg at an 8 week interval.
- Primary outcomeYearly cost of IFX treatment in the intervention versus the control group.
- Secondary outcome1. Proportion of patients with clinical and biochemical relapse;
2. Proportion of patients with sustained clinical remission;
3. Time to relapse;
4. Presence of predictive factors for successful dose reduction with specific focus on smoking status, body mass index and extent of disease;
5. Laboratory tests (CRP and fecal calprotectin) at all study visits;
6. Adverse events;
7. Pharmaco-economic evaluation.
- TimepointsPrimary endpoint: after 18 months of treatment.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. M. Löwenberg
- CONTACT for SCIENTIFIC QUERIESDr. M. Löwenberg
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryRationale:
Recent observations suggest that not all Crohn’s disease (CD) patients who are in stable remission with infliximab (IFX) maintenance therapy may need the recommended dose of 5 mg/kg, as long as IFX trough levels (TL) (e.g. serum drug level measured just before the next administration) remain therapeutic.

Objectives:
1. To investigate whether the per patient annual cost of IFX maintenance treatment can be lowered in CD patients in stable remission using dose reduction of IFX guided by serial TL measurements.
2. To identify predictors allowing selection of patients in whom dose reduction is easier and more successful using a logistic regression analysis.

Study design:
Double-blind prospective controlled randomized trial.

Study population:
Patients with CD older than 18 years, at least 6 months in remission defined as a Crohn's Disease Activity Index (CDAI) < 150, normal serum C-reactive protein (CRP) level (< 5 mg/l) and low fecal calprotectin level (< 250 ug/g) who have received IFX therapy > 6 months at 5 mg/kg every 8 weeks without dose adjustments. These patients are eligible if they have an IFX TL > 7 ug/ml.

Intervention:
Patients in the intervention arm will undergo stepwise dose reduction of IFX. IFX dose will be decreased by 1 mg/kg per step. The dose will be reduced every 16 weeks, as long as the following criteria are met: CDAl < 150, CRP < 5 and fecal calprotectin < 250 on the day of the visit AND IFX TL > 3 prior to the latest two infusions.
Patients in the control arm will receive continued IFX at 5 mg/kg at an 8 week interval.

Main study parameters/endpoints:
PRIMARY ENDPOINT: Yearly cost of IFX treatment in the intervention versus the control group.
SECONDARY ENDPOINTS: Proportion of patients with clinical and biochemical relapse; Proportion of patients with sustained clinical remission; Time to relapse; Presence of predictive factors for successful dose reduction with specific focus on smoking status, body mass index and extent of disease; Laboratory tests (CRP and fecal calprotectin) at all study visits; Adverse events; Pharmaco-economic evaluation; Quality of life.
- Main changes (audit trail)
- RECORD8-apr-2013 - 3-mei-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl