Evidence map›Paper›PMID 25281416›Full record

Trial reportGut2015

A phase II study of laquinimod in Crohn's disease.

Geert D'Haens, William J Sandborn, Jean Frederic Colombel, Paul Rutgeerts, Kurt Brown, Hadas Barkay, Anat Sakov, Asi Haviv, Brian G Feagan, Laquinimod for Crohn's Disease Investigators

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Gut, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00737932 (A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn's Disease.), which is not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
8.2field-weighted citation impact, top 3% 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.

NCT00737932 phase2completednot on this map

A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn's Disease.

TypeinterventionalSponsorTeva Branded Pharmaceutical Products R&D, Inc.Ran2010 to 2011Enrolled180ConditionsCrohn's DiseaseArmsLaquinimod, placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 80 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Calprotectin is regulated by IL-17A and induces steroid hyporesponsiveness in asthma.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2024
    Article
  8. Review
  9. Article
  10. Concerning the photophysics of fluorophores towards tailored bioimaging compounds: a case study involving S100A9 inflammation markers.Photochemical & photobiological sciences : Official journal of the European Photochemistry Association and the European Society for Photobiology · 2023
    Article
  11. Review
  12. Review
  13. Review
  14. Emerging therapeutic options in inflammatory bowel disease.World journal of gastroenterology · 2021
    Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Novel Non-biologic Targets for Inflammatory Bowel Disease.Current gastroenterology reports · 2019
    Review
  20. 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

10 authors at 6 institutions in 6 countries.

Geert D'HaensAcademic Medical Center, Amsterdam, The Netherlands.
William J SandbornAcademic Medical Center, Amsterdam, The Netherlands University of California San Diego, La Jolla, USA Icahn School of Medicine at Mount Sinai, New York, New York, UK Catholic University of Leuven, Belgium Teva Pharmaceuticals, Frazer, Pennsylvania, USA Teva Pharmaceuticals, Netanya, Israel Formerly Teva Pharmaceuticals, Netanya, Israel Chiasma Pharma, Jerusalem, Israel Robarts Research Institute University of Western Ontario, London, Ontario, Canada.
Jean Frederic ColombelUniversity of California San Diego, La Jolla, USA Icahn School of Medicine at Mount Sinai, New York, New York, UK.
Paul RutgeertsCatholic University of Leuven, Belgium.
Kurt BrownTeva Pharmaceuticals, Frazer, Pennsylvania, USA.
Hadas BarkayTeva Pharmaceuticals, Netanya, Israel.
Anat SakovTeva Pharmaceuticals, Netanya, Israel.
Asi HavivFormerly Teva Pharmaceuticals, Netanya, Israel Chiasma Pharma, Jerusalem, Israel.
Brian G FeaganRobarts Research Institute University of Western Ontario, London, Ontario, Canada.
Laquinimod for Crohn's Disease Investigators
Teva Pharmaceuticals (Israel) · ILIcahn School of Medicine at Mount Sinai · USAcademic Medical Center · NLKU Leuven · BERobarts Clinical Trials · CATeva Pharmaceuticals (Spain) · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveLaquinimod is an oral therapeutic agent under investigation for the treatment of Crohn's disease (CD), Huntington's disease, lupus nephritis and multiple sclerosis. This dose escalation study evaluated the safety and efficacy of laquinimod as induction therapy in patients with active moderate-severe CD.

designMulticentre, double-blind, sequential-cohort, randomised controlled trial with laquinimod doses of 0.5, 1, 1.5 or 2 mg/day or placebo (n=45 per cohort randomised in a 2:1 ratio) for 8 weeks with 4-week follow-up. Stable concomittant therapies and prior use of anti-tumour necrosis factor agents were permitted. Comprehensive safety assessments were performed and efficacy analyses included the proportions of patients in clinical remission (CD Activity Index (CDAI) <150 and no treatment failure (TF)), and with a clinical response (70 or 100 point CDAI reduction from baseline or remission and no TF).

results117 patients received laquinimod and 63 patients received placebo. The overall incidence of adverse events (AEs) in the laquinimod group was similar to the pooled placebo group (86.2%-96.7% vs 82.5%) and most AEs were mild to moderate in severity. Treatment with laquinimod 0.5 mg showed consistent effects on remission (48.3% (CI 31% to 66%) vs 15.9% (CI 9% to 27%)), response 100 (55.2% (CI 37% to 71%) vs 31.7% (CI 22% to 44%)) and response 70 (62.1% (CI 44% to 77%) vs 34.9% (CI 24% to 47%)) versus placebo. Laquinimod 1.0 mg showed less benefit (26.7% remission (CI 14% to 44%) and 53.3% response 70 (CI 36% to 70%)), and no effect was noted on remission/response at higher doses.

conclusionsLaquinimod was safe and well tolerated, and the effects on remission and response of the 0.5 mg dose suggest a treatment benefit in patients with CD. TRIAL REGISTRATION NUMBER: NCT00737932.

Indexed as

Administration, OralAdolescentAdultAgedAnti-Inflammatory AgentsCrohn DiseaseDose-Response Relationship, DrugDouble-Blind MethodFemaleFollow-Up StudiesHumansInduction ChemotherapyMaleMiddle AgedQuinolonesTreatment OutcomeAnti-Inflammatory AgentslaquinimodQuinolonesCLINICAL DECISION MAKINGCLINICAL TRIALSCROHN'S DISEASEIBD CLINICALPHARMACOTHERAPY

Identifiers

PMID25281416
PMCPMC4515993
OpenAlexW2139721118

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.