Evidence map›Paper›PMID 34147123›Full record

ArticleTrials2021

Using adalimumab serum concentration to choose a subsequent biological DMARD in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): study protocol for a fully blinded randomised superiority test-treatment trial.

Maike H M Wientjes, Sadaf Atiqi, Gerrit Jan Wolbink, Michael T Nurmohamed, Maarten Boers, Theo Rispens, Annick de Vries, Ronald F van Vollenhoven, Bart J F van den Bemt, Alfons A den Broeder

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 60% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

Maike H M WientjesDepartment of Rheumatology, Sint Maartenskliniek, PO box 9011, 6500 GM, Nijmegen, the Netherlands. m.wientjes@maartenskliniek.nl.ORCID http://orcid.org/0000-0002-6666-9378
Sadaf AtiqiDepartment of Rheumatology, Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, the Netherlands.
Gerrit Jan WolbinkDepartment of Rheumatology, Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, the Netherlands.
Michael T NurmohamedDepartment of Rheumatology, Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, the Netherlands.
Maarten BoersDepartment of Epidemiology and Data Science, Amsterdam Rheumatology and Immunology Center, UMC Amsterdam, Vrije Universiteit, Amsterdam, the Netherlands.
Theo RispensBiologics Lab, Sanquin Diagnostic Services, Sanquin, Amsterdam, the Netherlands.
Annick de VriesBiologics Lab, Sanquin Diagnostic Services, Sanquin, Amsterdam, the Netherlands.
Ronald F van VollenhovenDepartment of Rheumatology, Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, the Netherlands.
Bart J F van den BemtDepartment of Pharmacy, Sint Maartenskliniek, Nijmegen, the Netherlands.
Alfons A den BroederDepartment of Rheumatology, Sint Maartenskliniek, PO box 9011, 6500 GM, Nijmegen, the Netherlands.
Sanquin · NLAmsterdam UMC Location University of Amsterdam · NLRadboud University Nijmegen · NLReade · NLSint Maartenskliniek · NL

Funding

ZonMw 8481 01 006
6 · The paper itself

Abstract

backgroundA substantial proportion of rheumatoid arthritis (RA) patients discontinues treatment with tumour necrosis factor inhibitors (TNFi) due to inefficacy or intolerance. After the failure of treatment with a TNFi, treatment can be switched to another TNFi or a bDMARD with a different mode of action (non-TNFi). Measurement of serum drug concentrations and/or anti-drug antibodies (therapeutic drug monitoring (TDM)) may help to inform the choice for the next step. However, the clinical utility of TDM to guide switching has not been investigated in a randomised test-treatment study.

methodsADDORA-switch is a 24-week, multi-centre, triple-blinded, superiority test-treatment randomised controlled trial. A total of 84 RA patients failing adalimumab treatment (treatment failure defined as DAS28-CRP > 2.9) will be randomised in a 1:1 ratio to a switching strategy to either TNFi or non-TNFi based on adalimumab serum trough level (intervention group) or random allocation (control group). The primary outcome is the between-group difference in mean time-weighted DAS28 over 24 weeks. DISCUSSION: The trial design differs in many aspects from previously published and ongoing TDM studies and is considered the first blinded test-treatment trial using TDM in RA. Several choices in the design of this trial are described, and overarching principles regarding test-treatment trials and clinical utility of TDM are discussed in further detail.

trial registrationDutch Trial Register NL8210 . Registered on 3 December 2019 (CMO NL69841.091.19).

Indexed as

Antirheumatic AgentsArthritis, RheumatoidAdalimumabDrug MonitoringEquivalence Trials as TopicEtanerceptHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeTumor Necrosis Factor-alphaTumor Necrosis Factor InhibitorsAdalimumabAntirheumatic AgentsEtanerceptTumor Necrosis Factor-alphaTumor Necrosis Factor InhibitorsAdalimumabAnti-TNFDesignDrug concentrationRheumatoid arthritisSwitchingTest-treatment trialTherapeutic drug monitoring

Identifiers

PMID34147123
PMCPMC8214249
OpenAlexW3173619749

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.