Evidence map›Paper›PMID 33711991›Full record

Trial reportBMC musculoskeletal disorders2021

Pentosan polysulfate sodium for Ross River virus-induced arthralgia: a phase 2a, randomized, double-blind, placebo-controlled study.

Ravi Krishnan, Melanie Duiker, Penny A Rudd, Donna Skerrett, James G D Pollard, Carolyn Siddel, Rifat Rifat, Jennifer H K Ng, Peter Georgius, Lara J Hererro and 1 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.0field-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.

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

10 citing papers in PubMed, 13 citations in OpenAlex.

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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 3 institutions in 1 country.

Ravi KrishnanParadigm Biopharmaceuticals Ltd., Melbourne, Victoria, Australia.
Melanie DuikerParadigm Biopharmaceuticals Ltd., Melbourne, Victoria, Australia.
Penny A RuddInstitute for Glycomics, Griffith University, Southport, Queensland, Australia.
Donna SkerrettParadigm Biopharmaceuticals Ltd., Melbourne, Victoria, Australia.
James G D PollardClinical Trials Unit, Barwon Health, Geelong, Victoria, Australia.
Carolyn SiddelSprings Medical, Daylesford, Victoria, Australia.
Rifat RifatRich River Health Group, Echuca, Victoria, Australia.
Jennifer H K NgClinical Trials Unit (Griffith Health), Griffith University, Gold Coast, Australia and Gold Coast University, Gold Coast, Queensland, Australia.
Peter GeorgiusSunshine Coast Clinical Research, Gold Coast, Queensland, Australia.
Lara J Hererro *Institute for Glycomics, Griffith University, Southport, Queensland, Australia.
Paul Griffin *Department of Medicine and Infectious Diseases, Mater Misericordiae Ltd., Level 3, Aubigny Place, Raymond Terrace, South Brisbane, Queensland, 4101, Australia. paul.griffin@mater.org.au.
Griffith University · AUBarwon Health · AUMater Misericordiae Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlphaviruses, such as Ross River (RRV) and chikungunya virus (CHIKV), cause significant global morbidity, with outbreaks of crippling joint inflammation and pain, leaving patients incapacitated for months to years. With no available vaccine or specific therapeutic for any alphaviral disease, and a growing economic and public health burden, there is a serious need for the development of specific therapies.

methodsThis study evaluated the safety and efficacy of pentosan polysulfate sodium (PPS) in subjects with RRV-induced arthralgia in a double-blind, placebo-controlled trial. Twenty subjects were randomized 2:1 to subcutaneous PPS (2 mg/kg) or placebo (sodium chloride 0.9%) twice weekly for 6 weeks. Safety evaluation included physical examination, concomitant medications, and laboratory findings. Efficacy assessments included change from baseline in joint function (hand grip strength and RAPID3) and quality of life (SF-36) at Days 15, 29, 39 and 81 after treatment initiation. Inflammatory and cartilage degradation biomarkers were exploratory endpoints.

resultsPPS was well tolerated, with a similar proportion of subjects reporting at least one treatment-emergent adverse event (TEAE) in the treatment and placebo groups. Injection site reactions were the most common TEAE and occurred more frequently in the PPS group. Dominant hand grip strength and SF-36 scores improved with PPS at all time points assessed, with hand grip strength improvement of 6.99 kg (p = 0.0189) higher than placebo at Day 15. PPS showed significant improvements versus placebo in adjusted mean relative change from baseline for RAPID3 Pain (p = 0.0197) and Total (p = 0.0101) scores at Day 15. At the conclusion of the study overall joint symptoms, assessed by RAPID3, showed near remission in 61.5% of PPS subjects versus 14.3% of placebo subjects. Additionally, PPS treatment improved COMP, CTX-II, CCL1, CXCL12, CXCL16 and CCL17 biomarker levels versus placebo.

conclusionsOverall, the improvements in strength and joint symptoms warrant further evaluation of PPS as a specific treatment for RRV-induced and other forms of arthritis.

trial registrationThis trial is registered at the Australian New Zealand Clinical Trials Registry # ACTRN12617000893303 .

Indexed as

Pentosan Sulfuric PolyesterRoss River virusArthralgiaAustraliaDouble-Blind MethodHand StrengthHumansQuality of LifeTreatment OutcomePentosan Sulfuric PolyesterAlphavirusArthritisPainPentosan polysulfate sodiumRoss River virus

Identifiers

PMID33711991
PMCPMC7955617
OpenAlexW3134144190

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.