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)


Therapeutic drug monitoring: Toward tailored dosing of adalimumab in rheumatoid arthritis.


- candidate number13106
- NTR NumberNTR3509
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jul-2012
- Secondary IDsP1245 METC Slotervaartziekenhuis
- Public TitleTherapeutic drug monitoring: Toward tailored dosing of adalimumab in rheumatoid arthritis.
- Scientific TitleTherapeutic drug monitoring: Toward tailored dosing of adalimumab in rheumatoid arthritis.
- ACRONYM
- hypothesisWe hypothesize that in rheumatoid arthritis (RA) patients responding to adalimumab, with high adalimumab serum concentrations at least 28 weeks after treatment initiation:
1. Lowering the serum concentrations through dose interval prolongation will not influence disease activity and hence;
2. Through lower costs, dose interval prolongation will be more cost–effective than the traditional treatment scheme.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis, Adalimumab, Therapeutic drug monitoring
- Inclusion criteria1. RA according to the ACR 1987 criteria;
2. Adalimumab treatment for at least 28 weeks;
3. Treating rheumatologist is convinced of the benefit of adalimumab continuation;
4. Written informed consent.
5. Trough adalimumab level > 8.0 mg/L
- Exclusion criteriaScheduled surgery in the next 6 months or other pre planned reasons for treatment discontinuation.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2012
- planned closingdate1-okt-2015
- Target number of participants102
- InterventionsPatients with high adalimumab concentrations will be randomly assigned to continuation of adalimumab every other week or prolongation of the dosage interval to once every 3 weeks. Patients will be followed for 6 months.
- Primary outcomeSimilar deltaDAS28 in patients with high serum adalimumab concentrations who are randomly assigned to continuation of the regular dose or to dose interval prolongation.
- Secondary outcomeCost-effectiveness of therapeutic drug monitoring in rheumatoid arthritis patients responding to adalimumab.
- Timepoints-2 weeks, 0, 2 and 6 months.
- Trial web sitewww.reade.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. G.J. Wolbink
- CONTACT for SCIENTIFIC QUERIESDr. G.J. Wolbink
- Sponsor/Initiator Reade
- Funding
(Source(s) of Monetary or Material Support)
Reumafonds, Reade
- PublicationsN/A
- Brief summaryRationale:
Treatment with biologicals is based on the principle of 'one size fits all'. In the dosing scheme, patients characteristics or pharmacokinetic aspects are not taken into account. In addition, when a patient responds well to the drug, the question whether the dose can be de-escalated or the drug can be discontinued, remains unanswered. Based on literature, dose de-escalation seems to be safe with regard to disease activity and might be beneficial in lowering the risk of adverse events. An important additional aspect is the large amount of costs that can be saved when the same response rates are achieved with less medication.

Objective:
To examine response of disease activity in patients with high serum adalimumab concentration who are randomly assigned to continuation of the regular dose or to dose interval prolongation and to examine the cost-effectiveness of this therapeutic drug monitoring strategy.

Study design:
Open randomised controlled study of therapeutic drug monitoring in RA patients treated with adalimumab.

Intervention:
Patients with high adalimumab concentrations will be randomly assigned to continuation of adalimumab every other week or prolongation of the dosage interval to once every 3 weeks. Patients will be followed for 6 months.

Main study parameters:
Adalimumab serum concentrations define whether a patient is suitable for inclusion and randomisation. Adalimumab serum concentrations, disease activity and cost related parameters will be measured during follow-up.

Nature and extent of the burden:
We hypothesize that in patients with high adalimumab concentrations and dose interval prolongation disease activity remains stable, however, an increased disease activity risk can not be excluded.
- Main changes (audit trail)
- RECORD5-jul-2012 - 18-dec-2013


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