Evidence map›Paper›PMID 39030450›Full record

Trial reportInflammopharmacology2024

Trivalent chromium versus baricitinib for rheumatoid arthritis treatment: first phase 2/3 randomized controlled trial, is trivalent chromium the upcoming immune-modulator?

Sally S Hassouna, Omneya Mohamed-Ayman Abdel-Moniem

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIClinical Trial, Phase III
In one paragraph

Trial report in Inflammopharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05545020 (Trivalent Chromium as a Treatment for Rheumatoid Arthritis Patients), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT05545020 phase2 / phase3completednot on this map

Trivalent Chromium as a Treatment for Rheumatoid Arthritis Patients

TypeinterventionalSponsorAlexandria UniversityRan2022 to 2024Enrolled60ConditionsRheumatoid ArthritisArmsTrivalent chromium versus synthetic and/ or biological DMARDs
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

2 authors.

Sally S HassounaInternal Medicine Department, Rheumatology and Clinical Immunology Unit, Faculty of Medicine, Alexandria University, Alexandria, Egypt. s_hassouna151@alexmed.edu.eg.ORCID http://orcid.org/0000-0002-7259-5678
Omneya Mohamed-Ayman Abdel-MoniemRheumatology, Rehabilitation and Physical Medicine Department, Faculty of Medicine, Alexandria University, Alexandria, Egypt.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRheumatoid arthritis (RA) is a debilitating disease mainly treated by DMARDs. Baricitinib is one of the emerging DMARDs with strong anti-rheumatic effects but has serious side effects. Trivalent chromium (Cr III) is a natural element with anti-inflammatory properties. Trivalent chromium (Cr III) is introduced for the first time to study its effect and safety in treatment of RA patients and compared to those of baricitinib.

methodsThis is a phase 2/3 randomized controlled trial where RA patients were divided in a ratio of 2:1 according to the newly introduced medication either Cr (III) (group A) or baricitinib (group B). Patients attended three visits on day 0, after 3 weeks and 12 weeks, disease activity was scored. Hands ultrasound was done and reassessed. Side effects were monitored throughout the study.

resultsDAS28-CRP improved by 26.9% and 11.8% on third visit for Cr III and baricitinib, respectively (p = 0.001). DAS28-ESR improved by 25.6% and 7.74% on third visit for Cr III and baricitinib, respectively (p =  < 0.001). ACR 50 was 18.8% for Cr III and 5.7% for baricitinib on second visit. ACR 70 was 25% for Cr III and 0% for baricitinib on third visit (P =  < 0.001). Ultrasound GLOESS, SH, PDUS, joints effusions improved by 38.9%, 38.4%, 56.7% and 74.8% for Cr III, while by 10.5%, 3.75%, 59.6% and worsening of joints effusions happened with baricitinib on third visit. p = 0.022 and 0.002 between groups for GLOESS and SH improvement, respectively.

conclusionsCr III has shown very promising fast clinical and sonographic results in treating RA patients which were surprisingly superior to baricitinib in most aspects. Furthermore, Cr III is potentially safe with evidently fewer side effects than baricitinib and other DMARDs, however, long-term safety is still not established. (IRB No.: 00012098- FWA No.: 00018699, Serial number: 040457) ClinicalTrials.gov ID: NCT05545020.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidAzetidinesChromiumPurinesPyrazolesSulfonamidesAdultAgedFemaleHumansMaleMiddle AgedTreatment OutcomeAntirheumatic AgentsAzetidinesbaricitinibChromiumPurinesPyrazolesSulfonamidesACR responseBaricitinibCDAIDAS28-CRPDAS28-ESRGLOESSHAQDIJoints effusionsLow disease activity and disease remissionPDUSRheumatoid arthritisSDAISHTrivalent chromium

Identifiers

PMID39030450
PMCPMC11416422

What Socratic holds

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Registered trials

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.