Evidence map›Paper›PMID 39533416›Full record

ArticleTrials2024

Induction of Cure in Early Arthritis (I CEA): study protocol for an investigator-initiated randomized single-blind clinical trial with open-label extension to compare three treatment strategies in patients with newly diagnosed undifferentiated arthritis.

S A Bergstra, L van Ouwerkerk, I S Nevins, J A van der Pol, G S Helmich, I Hest, A van Veen, R Bos, Y P M Goekoop-Ruiterman, H E Vonkeman and 6 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. 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
–field-weighted citation impact
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.

  1. Trial
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

16 authors.

S A BergstraDepartment of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands. s.a.bergstra@lumc.nl.ORCID http://orcid.org/0000-0002-7136-5248
L van OuwerkerkDepartment of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.
I S NevinsDepartment of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.
J A van der PolDepartment of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.
G S HelmichDepartment of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.
I HestPatient Partner Panel, Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.
A van VeenPatient Partner Panel, Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.
R BosDepartment of Rheumatology, Medical Center Leeuwarden, Leeuwarden, the Netherlands and Department of Rheumatology, Nij Smellinghe Hospital, Drachten, the Netherlands.
Y P M Goekoop-RuitermanDepartment of Rheumatology, HagaHospital, the Hague, the Netherlands.
H E VonkemanDepartment of Rheumatology and Clinical Immunology, Medisch Spectrum Twente, Enschede, the Netherlands and Department of Psychology, Health and Technology, University of Twente, Enschede, the Netherlands.
J BijsterboschDepartment of Rheumatology, Amphia Hospital, Breda, the Netherlands.
P H P de JongDepartment of Rheumatology, Erasmus Medical Center, Rotterdam, the Netherlands.
M Güler-YükselDepartment of Rheumatology and Immunology, Maasstad Hospital, Rotterdam, the Netherlands.
S BöhringerBiomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands and Department of Pharmacology and Toxicology, Leiden University Medical Center, Leiden, the Netherlands.
T W J HuizingaDepartment of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.
F A van GaalenDepartment of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUndifferentiated arthritis (UA) is a term used to describe patients with inflammatory arthritis that has not differentiated into a specific rheumatic disease. UA may be a pre-stage of rheumatoid arthritis (RA) or another inflammatory disease or remain undifferentiated, but a substantial proportion of patients may also achieve spontaneous remission. As UA may be an early presentation of RA, rheumatologists often start methotrexate (or another csDMARD) as early as possible. There are however very little data on the potential benefits of early DMARD treatment, and longitudinal data suggests that long-term outcomes such as physical functioning hardly improved in these patients in the past decades. In the I CEA trial, we investigate if it is beneficial to start early treatment with MTX or baricitinib, a more rapidly acting drug with a broader mechanism of action, compared to waiting for spontaneous remission with symptomatic therapy in patients with UA.

methodsThe I CEA is a multicenter single-blind (independent assessor) randomized clinical trial with a 3-month interventional and 9-month observational follow-up period. The study includes patients with early (< 1 year symptom duration) DMARD-naïve undifferentiated arthritis. Patients with an increased risk of AEs with baricitinib treatment are excluded. Participants are randomized 1:1:1 to (1) symptom relief with NSAIDs and a single injection of glucocorticoids and (waiting for spontaneous remission); (2) methotrexate and a single injection of glucocorticoids, and NSAIDs are optional; and (3) baricitinib and a single injection of glucocorticoids and NSAIDs are optional. During the observational follow-up period, patients are treated in shared decision with their rheumatologist. The primary outcome will be the change in DAS at 3 months. Secondary outcomes include radiographic progression, physical functioning, patient-reported outcomes, cost utilities, safety, progression to classifiable RA, and disease activity over time. DISCUSSION: The 12-month I CEA trial studies early treatment of patients with UA with methotrexate, baricitinib, or NSAIDs. The study initially had a more complex design. Emerging safety warnings about baricitinib necessitated adjustment of the trial protocol including more extensive exclusion criteria. The number of included patients was lower than initially planned, supported by an updated sample size calculation.

trial registrationDutch trial register NL73202.058.20, EudraCT 2019-004359-35, registered 10-06-2020. Protocol version 1Q, 06-05-2024.

Indexed as

Antirheumatic AgentsArthritisRandomized Controlled Trials as TopicSulfonamidesAzetidinesHumansMethotrexateMulticenter Studies as TopicNetherlandsPurinesPyrazolesRemission InductionSingle-Blind MethodTime FactorsTreatment OutcomeAntirheumatic AgentsAzetidinesbaricitinibMethotrexatePurinesPyrazolesSulfonamidesBaricitinibDisease activityMethotrexateNSAIDRandomizedRheumatoid arthritisSingle-blind trialSpontaneous remissionUndifferentiated arthritis

Identifiers

PMID39533416
PMCPMC11558825

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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.