Evidence map›Paper›PMID 17962237›Full record

Trial reportAnnals of the rheumatic diseases2008

Efficacy and safety of a novel synergistic drug candidate, CRx-102, in hand osteoarthritis.

T K Kvien, E Fjeld, B Slatkowsky-Christensen, M Nichols, Y Zhang, A Prøven, K Mikkelsen, Ø Palm, A A Borisy, J Lessem

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 5 pooled it
4.6field-weighted citation impact, top 6% 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

24 citing papers in PubMed, 5 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Observational
  15. Article
  16. Review
  17. Article
  18. The role of synovitis in osteoarthritis.Therapeutic advances in musculoskeletal disease · 2010
    Article
  19. Article
  20. Time for new outcome measures in hand osteoarthritis?Nature clinical practice. Rheumatology · 2009
    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 4 institutions in 2 countries.

T K KvienDepartment of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, N-0319 Oslo, Norway. t.k.kvien@medisin.uio.no
E Fjeld
B Slatkowsky-Christensen
M Nichols
Y Zhang
A Prøven
K Mikkelsen
Ø Palm
A A Borisy
J Lessem
BioFormatix (United States) · USDiakonhjemmet Hospital · NOMartina Hansens Hospital · NOØstfold Hospital Trust · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe novel synergistic drug candidate CRx-102 comprises dipyridamole and low dose prednisolone and is in clinical development for the treatment of immunoinflammatory diseases. The purpose of this clinical study was to examine the efficacy and safety of CRx-102 in patients with hand osteoarthritis (HOA).

methodsThe study was conducted as a blinded, randomised, placebo-controlled trial at four centres in Norway. Eligibility criteria included being of age 30-70 years, at least one swollen and tender joint, a Kellgren-Lawrence (K-L) score of 2 or higher on radiographs, and a score of at least 30 mm pain on the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) visual analogue pain scale (VAS). The primary endpoint was a reduction in pain from baseline to day 42 on the AUSCAN pain subscale. Two-sided p values for the differences in least squares (LS) means adjusted for baseline are presented.

resultsThe mean age of the 83 patients with HOA was 60 years and 93% were females. CRx-102 was statistically superior to placebo at 42 days for changes in AUSCAN pain (LS mean -14.2 vs -4.0) and for clinically relevant secondary endpoints (joint pain VAS (-18.6 vs -6.3), patient global VAS (-15.9 vs -4.2)) in the intention to treat population. The most frequently reported adverse event during the study was headache (52% in CRx-102 vs 15% in the placebo group).

conclusionsThe novel synergistic drug candidate CRx-102 demonstrated efficacy by statistically reducing pain compared to placebo in HOA and was generally well tolerated.

Indexed as

Hand JointsAdultAgedAnti-Inflammatory AgentsDipyridamoleDouble-Blind MethodDrug CombinationsFemaleHumansMaleMiddle AgedOsteoarthritisPain MeasurementPrednisoloneSeverity of Illness IndexTreatment OutcomeAnti-Inflammatory AgentsDipyridamoledipyridamole, prednisolone drug combinationDrug CombinationsPrednisolone

Identifiers

PMID17962237
PMCPMC2564788
OpenAlexW2126367911

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.