Evidence map›Paper›PMID 29088579›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2018

Brief Report: A Phase IIb Trial of a Novel Extended-Release Microsphere Formulation of Triamcinolone Acetonide for Intraarticular Injection in Knee Osteoarthritis.

Philip G Conaghan, Stanley B Cohen, Francis Berenbaum, Joelle Lufkin, James R Johnson, Neil Bodick

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 4 pooled it
7.3field-weighted citation impact, top 2% 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.

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

53 citing papers in PubMed, 4 syntheses or guidelines pooled it, 87 citations in OpenAlex.

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  15. The Challenges of Local Intra-Articular Therapy.Medicina (Kaunas, Lithuania) · 2024
    Review
  16. Article
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  20. Knee osteoarthritis: disease burden, available treatments, and emerging options.Therapeutic advances in musculoskeletal disease · 2024
    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

6 authors at 4 institutions in 3 countries.

Philip G ConaghanUniversity of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, UK.
Stanley B CohenUniversity of Texas, Southwestern Medical School, Dallas.
Francis BerenbaumPierre and Marie Curie University, Paris, France.
Joelle LufkinFlexion Therapeutics, Burlington, Massachusetts.
James R JohnsonFlexion Therapeutics, Burlington, Massachusetts.
Neil BodickFlexion Therapeutics, Burlington, Massachusetts.
Flexion Therapeutics (United States) · USSorbonne Université · FRThe University of Texas Southwestern Medical Center · USUniversity of Leeds · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveFX006 is a novel, microsphere-based, extended-release formulation of triamcinolone acetonide for intraarticular (IA) injection designed to maintain treatment concentration in the joint and provide prolonged analgesic benefits in patients with osteoarthritis (OA) of the knee. This study was undertaken to compare the analgesic benefits of 2 FX006 doses with saline placebo injection.

methodsIn this phase IIb study, participants with knee OA (Kellgren/Lawrence grade 2-3) and average daily pain (ADP) intensity ≥5 to ≤9 (on a 0-10 Numerical Rating Scale) were randomized (1:1:1) to receive single IA injections of FX006 32 mg (n = 104) or 16 mg (n = 102) or saline placebo (n = 100). The primary end point was the least squares mean (LSM) change from baseline to week 12 in weekly mean ADP intensity scores for FX006 32 mg versus saline placebo.

resultsThe primary end point was not met (LSM change at week 12 -3.1 with FX006 32 mg versus -2.5 with saline placebo; LSM difference [95% confidence interval] -0.58 [-1.22, 0.07]) (P = 0.08). However, improvements in ADP intensity were significantly greater with FX006 32 mg than saline placebo at weeks 1-11 and week 13. Improvements in ADP intensity were significantly greater with FX006 16 mg versus saline placebo at weeks 1-9. A dose-response effect in duration of maximal analgesic effect was evident (13 weeks with 32 mg versus 9 weeks with 16 mg), with FX006 32 mg providing increased therapeutic benefit relative to FX006 16 mg. All treatments were well tolerated.

conclusionAlthough the primary end point was not met, our findings indicate a prolonged reduction in symptoms with FX006 with an evident dose response and a safety profile similar to saline placebo.

Indexed as

AgedAnti-Inflammatory AgentsDelayed-Action PreparationsDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansInjections, Intra-ArticularKnee JointMaleMicrospheresMiddle AgedOsteoarthritis, KneePainPain MeasurementTreatment OutcomeAnti-Inflammatory AgentsDelayed-Action PreparationsTriamcinolone Acetonide

Identifiers

PMID29088579
PMCPMC5814922
OpenAlexW2765240768

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.