Evidence map›Paper›PMID 25147819›Full record

Trial reportBioMed research international2014

The effect of rilonacept versus placebo on health-related quality of life in patients with poorly controlled familial Mediterranean fever.

Philip J Hashkes, Steven J Spalding, Rula Hajj-Ali, Edward H Giannini, Anne Johnson, Karyl S Barron, Michael H Weisman, Noune Pashinian, Andreas O Reiff, Jonathan Samuels and 3 more

Registry-linked trialOpen access · hybridAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BioMed research international, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00582907 (Phase 2 Study of IL-1 Trap), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 14% 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.

NCT00582907 phase2completednot on this map

Phase 2 Study of IL-1 Trap (Rilonacept) for Treatment of Familial Mediterranean Fever (FMF)

TypeinterventionalSponsorThe Cleveland ClinicRan2008 to 2011Enrolled14ConditionsFamilial Mediterranean FeverArmsRilonacept, Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Interventions for reducing inflammation in familial Mediterranean fever.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Interventions for reducing inflammation in familial Mediterranean fever.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Placebo-resistant gut bacteria:Frontiers in cellular and infection microbiology · 2024
    Trial
  4. Article
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Familial Mediterranean Fever: Assessing the Overall Clinical Impact and Formulating Treatment Plans.Mediterranean journal of hematology and infectious diseases · 2019
    Review
  11. Review
  12. Review
  13. Review
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

13 authors at 8 institutions in 2 countries.

Philip J HashkesCleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA ; Pediatric Rheumatology Unit, Shaare Zedek Medical Center, P.O. Box 3235, 91031 Jerusalem, Israel.
Steven J SpaldingCleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA.
Rula Hajj-AliCleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA.
Edward H GianniniCincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA.
Anne JohnsonCincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA.
Karyl S BarronDivision of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, DHHS, 33 North Drive, MSC 3207, Bethesda, MD 20892, USA.
Michael H WeismanCedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048, USA.
Noune PashinianCedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048, USA.
Andreas O ReiffChildren's Hospital of Los Angeles, 4650 Sunset Boulevard, Los Angeles, CA 90027, USA.
Jonathan SamuelsNYU Langone Hospital for Joint Diseases, 301 East 17th Street, New York, NY 10003, USA.
Dowain WrightChildren's Hospital Central California, 9300 Valley Children's Place, Madera, CA 93636, USA.
Daniel J LovellCincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA.
Bin HuangCincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA.
Cincinnati Children's Hospital Medical Center · USCedars-Sinai Medical Center · USCleveland Clinic · USChildren's Hospital Central California · USChildren's Hospital of Los Angeles · USNational Institutes of Health · USNew York University Langone Orthopedic Hospital · USShaare Zedek Medical Center · IL

Funding

Phase II, IL-1 Trap for Treatment of Familial Mediterranean FeverR01FD003435 · FDA · CLEVELAND CLINIC FOUNDATION · PI SPALDING, STEVEN J · 2007 to 2010
$1.1M
FDA HHS R01 FD003435Intramural NIH HHS
6 · The paper itself

Abstract

objectiveTo examine the effect of rilonacept on the health-related quality of life (HRQoL) in patients with poorly controlled familial Mediterranean fever (FMF).

methodsAs part of a randomized, double-blinded trial comparing rilonacept and placebo for the treatment of FMF, patients/parents completed the modified Child Health Questionnaire (CHQ) at baseline, and at the start and end of each of 4 treatment courses, 2 each with rilonacept and placebo.

resultsFourteen subjects were randomized; mean age was 24.4 ± 11.8 years. At baseline the physical HRQoL score was significantly less (24.2 ± 49.5) but the psychosocial score was similar to the population norm (49.5 ± 10.0). There were significant improvements in most HRQoL concepts after rilonacept but not placebo. Significant differences between rilonacept and placebo were found in the physical (33.7 ± 16.4 versus 23.7 ± 14.5, P = 0.021) but not psychosocial scores (51.4 ± 10.3 versus 49.8 ± 12.4, P = 0.42). The physical HRQoL was significantly impacted by the treatment effect and patient global assessment.

conclusionTreatment with rilonacept had a beneficial effect on the physical HRQoL in patients with poorly controlled FMF and was also significantly related to the patient global assessment. This trial is registered with ClinicalTrials.gov Identifier NCT00582907.

Indexed as

AdultDouble-Blind MethodFamilial Mediterranean FeverFemaleHumansMaleQuality of LifeRecombinant Fusion ProteinsSurveys and QuestionnairesTreatment OutcomeYoung AdultRecombinant Fusion Proteinsrilonacept

Identifiers

PMID25147819
PMCPMC4131422
OpenAlexW2147942453

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.