Evidence map›Paper›PMID 31907004›Full record

ArticleTrials2020

Pharmacological conditioning in the treatment of recent-onset rheumatoid arthritis: a randomized controlled trial study protocol.

Meriem Manaï, Henriët van Middendorp, Dieuwke S Veldhuijzen, Joy A van der Pol, Tom W J Huizinga, Andrea W M Evers

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

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 52% 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

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
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

6 authors at 2 institutions in 1 country.

Meriem ManaïFaculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, P.O. Box 9555, 2300 RB, Leiden, The Netherlands. Manai@fsw.leidenuniv.nl.ORCID http://orcid.org/0000-0002-4684-9224
Henriët van MiddendorpFaculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, P.O. Box 9555, 2300 RB, Leiden, The Netherlands.
Dieuwke S VeldhuijzenFaculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, P.O. Box 9555, 2300 RB, Leiden, The Netherlands.
Joy A van der PolDepartment of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.
Tom W J HuizingaDepartment of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.
Andrea W M EversFaculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, P.O. Box 9555, 2300 RB, Leiden, The Netherlands.
Leiden University · NLLeiden University Medical Center · NL

Funding

H2020 European Research Council ERC-2013-CoG-617700_EXPECT HEAL-TH
6 · The paper itself

Abstract

backgroundIn pharmacological conditioning associations are formed between the effects of medication and contextual factors related to the medication. Pharmacological conditioning with placebo medication can result in comparable treatment effects and reduced side effects compared to regular treatment in various clinical populations, and may be applied to achieve enhanced drug effects. In the current study protocol, pharmacological conditioning is applied to achieve enhanced treatment effects in patients with recent-onset rheumatoid arthritis (RA). The results from this study broaden the knowledge on the potential of pharmacological conditioning and provide a potential innovative treatment option to optimize long-term pharmacological treatment effectiveness for patients with inflammatory conditions, such as recent-onset RA.

methodsA multicenter, randomized controlled clinical trial is conducted in patients with recent-onset RA. Participants start on standardized pharmacological treatment for 16 weeks, which consists of methotrexate (MTX) 15 mg/week and a tapered schedule of prednisone 60 mg or 30 mg. After 4 months, participants in clinical remission (based on the rheumatologist's opinion and a targeted score below 1.6 on a 44-joint disease activity score (DAS44)) are randomized to 1 of 2 groups: (1) the control group (C), which continues with a standardized treatment schedule of MTX 15 mg/week or (2) the pharmacological conditioning group (PC), which receives an MTX treatment schedule in alternating high and low dosages. In the case of persistent clinical remission after 8 months, treatment is tapered and discontinued linearly in the C group and variably in the PC group. Both groups receive the same cumulative amount of MTX during each period. Logistic regression analysis is used to compare the proportion of participants with drug-free clinical remission after 12 months between the C group and the PC group. Secondary outcome measures include clinical functioning, laboratory assessments, and self-reported measures after each 4-month period up to 18 months after study start. DISCUSSION: The results from this study broaden the knowledge on the potential of pharmacological conditioning and provide a potential innovative treatment option to optimize long-term pharmacological treatment effectiveness in patients with inflammatory conditions, such as recent-onset RA.

trial registrationNetherlands Trial Register, NL5652. Registered on 3 March 2016.

Indexed as

Conditioning, PsychologicalAdultAntirheumatic AgentsArthritis, RheumatoidDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationEquivalence Trials as TopicHumansMethotrexateMulticenter Studies as TopicNetherlandsPrednisoneRandomized Controlled Trials as TopicRemission InductionAntirheumatic AgentsMethotrexatePrednisoneConditioningInstrumental learningPharmacological conditioningPlaceboPsychological treatmentRandomized controlled trialRheumatoid arthritisStudy design

Identifiers

PMID31907004
PMCPMC6945543
OpenAlexW3000692342

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 OpenQuestion graph.