Evidence map›Paper›PMID 22562974›Full record

Trial reportAnnals of the rheumatic diseases2013

Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2).

Frank Buttgereit, Daksha Mehta, John Kirwan, Jacek Szechinski, Maarten Boers, Rieke E Alten, Jerzy Supronik, Istvan Szombati, Ulrike Romer, Stephan Witte and 1 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00650078 (A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone), which is not on this map. Cited by 74 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 3 pooled it
18.2field-weighted citation impact, top 1% 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.

NCT00650078 phase3completednot on this map

A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Rheumatoid Arthritis

TypeinterventionalSponsorAmgenRan2008 to 2009Enrolled350ConditionsRheumatoid ArthritisArmsMR prednisone, Placebo
3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 3 syntheses or guidelines pooled it, 185 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Circadian Modulation of the Antioxidant Effect of Grape Consumption: A Randomized Controlled Trial.International journal of environmental research and public health · 2023
    Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Observational
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Glucocorticoid-Induced Osteoporosis (GIOP).Indian journal of orthopaedics · 2023
    Review
  18. Review
  19. Circadian Regulation of Macrophages and Osteoclasts in Rheumatoid Arthritis.International journal of molecular sciences · 2023
    Review
  20. Review

14 more citing papers are in PubMed but not listed here.

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

11 authors at 7 institutions in 6 countries.

Frank ButtgereitDepartment of Rheumatology and Clinical Immunology, Charité University Medicine, Berlin 10117, Germany. frank.buttgereit@charite.de
Daksha Mehta
John Kirwan
Jacek Szechinski
Maarten Boers
Rieke E Alten
Jerzy Supronik
Istvan Szombati
Ulrike Romer
Stephan Witte
Kenneth G Saag
Charité - Universitätsmedizin Berlin · DEAltoona Arthritis and Osteoporosis Center · USAmsterdam UMC Location VUmc · NLNZOZ Centrum Alergologii · PLRegional Environmental Center for Central and Eastern Europe · HUUniversity of Alabama at Birmingham · USUniversity of Bristol · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the efficacy and safety of low-dose prednisone chronotherapy using a new modified-release (MR) formulation for the treatment of rheumatoid arthritis (RA).

methodsIn this 12-week, double-blind, placebo-controlled study, patients with active RA (n=350) were randomised 2:1 to receive MR prednisone 5 mg or placebo once daily in the evening in addition to their existing RA disease-modifying antirheumatic drug (DMARD) treatment. The primary end point was the percentage of patients achieving a 20% improvement in RA signs and symptoms according to American College of Rheumatology criteria (ie, an ACR20 response) at week 12. Changes in morning pain, duration of morning stiffness, 28-joint Disease Activity Score and health-related quality of life were also assessed.

resultsMR prednisone plus DMARD treatment produced higher response rates for ACR20 (48% vs 29%, p<0.001) and ACR50 (22% vs 10%, p<0.006) and a greater median relative reduction from baseline in morning stiffness (55% vs 35%, p<0.002) at week 12 than placebo plus DMARD treatment. Significantly greater reductions in severity of RA (Disease Activity Score 28) (p<0.001) and fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue score) (p=0.003) as well as a greater improvement in physical function (36-item Short-Form Health Survey score) (p<0.001) were seen at week 12 for MR prednisone versus placebo. The incidence of adverse events was similar for MR prednisone (43%) and placebo (49%).

conclusionLow-dose MR prednisone added to existing DMARD treatment produced rapid and relevant improvements in RA signs and symptoms. CLINICALTRIALS.GOV, NUMBER: NCT00650078.

Indexed as

AdultAgedAged, 80 and overAnti-Inflammatory AgentsAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug ChronotherapyFemaleHumansMaleMiddle AgedPainPrednisoneQuality of LifeAnti-Inflammatory AgentsAntirheumatic AgentsPrednisone

Identifiers

PMID22562974
PMCPMC3553491
OpenAlexW2136255927

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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 OpenQuestion graph.