Evidence map›Paper›PMID 35897052›Full record

ArticleTrials2022

Efficacy and safety of progressively reducing biologic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis in persistent remission: a study protocol for a non-inferiority randomized, controlled, single-blind trial.

Shangwen Lei, Zijia Li, Xiaoli Zhang, Shuhong Zhou

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

4 authors.

Shangwen LeiDepartment of Rheumatology, Gansu Provincial People's Hospital, 204 Donggang West Road, Lanzhou, 730000, People's Republic of China. leishangwen20210902@outlook.com.
Zijia LiDepartment of Rheumatology, Gansu Provincial People's Hospital, 204 Donggang West Road, Lanzhou, 730000, People's Republic of China.
Xiaoli ZhangDepartment of Thoracic surgery, Gansu Provincial People's Hospital, Lanzhou, 730000, People's Republic of China.
Shuhong ZhouDepartment of Rheumatology, Gansu Provincial People's Hospital, 204 Donggang West Road, Lanzhou, 730000, People's Republic of China.

Funding

Gansu Natural Science Foundation 21JR11RA188Lanzhou Science and Technology Bureau 2019-ZD-06
6 · The paper itself

Abstract

backgroundTo compare the effects of two biologic disease-modifying antirheumatic drug (bDMARD) administration strategies on the maintenance effect and safety of patients with rheumatoid arthritis (RA) in remission, to analyze the effects of gradual drug reduction and dose maintenance treatment on clinical outcomes in patients who have achieved remission with different types of bDMARDs, to search and screen out people who may benefit from drug reduction strategies, and to provide references for drug reduction strategies and treatment options for patients with RA in remission, so as to help improve the safety of the treatment and reduce the economic burden.

methodsThe study will be a 24-month non-inferiority randomized, controlled, single-blind trial and is planned to be launched in our hospital from September 2021 to August 2023. Patients will be randomized in a ratio of 2:1 to two groups: maintenance or injection spacing by 50%/gradual reduction of dosage every 3 months up to complete stop. When the patient relapses, return to the last effective dose. If the remission can be maintained, the medication of bDMARDs can be stopped 9 months after enrollment. The primary outcome will be the persistent flare rate. DISCUSSION: Our study may provide a reference for the selection of drug reduction strategies and treatment options for patients with RA in remission, so as to help improve the safety of the treatment and reduce the economic burden.

trial registrationChinese Clinical Trial Registry ChiCTR2100044751. Registered on 26 March 2021.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidBiological ProductsEquivalence Trials as TopicHumansRandomized Controlled Trials as TopicRemission InductionSingle-Blind MethodTreatment OutcomeAntirheumatic AgentsBiological ProductsBiologic disease-modifying antirheumatic drugsPersistent remissionRheumatoid arthritisTrial

Identifiers

PMID35897052
PMCPMC9327307

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Registered trials

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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.