Evidence map›Paper›PMID 23945134›Full record

Trial reportArthritis research & therapy2013

Serological identification of fast progressors of structural damage with rheumatoid arthritis.

Anne Sofie Siebuhr, Anne C Bay-Jensen, Diana J Leeming, Adam Plat, Inger Byrjalsen, Claus Christiansen, Désirée van de Heijde, Morten A Karsdal

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00106535 (A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis), which is not on this map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
–field-weighted citation impact
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.

NCT00106535 phase3completednot on this map

A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis

TypeinterventionalSponsorHoffmann-La RocheRan2005 to 2012Enrolled1,196ConditionsRheumatoid ArthritisArmstocilizumab [RoActemra/Actemra], Placebo, Methotrexate
3 · Its place in the literature

Who cites it

40 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Serological biomarkers of joint tissue turnover predict tocilizumab response at baseline.Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases · 2014
    Trial
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Clinical monitoring in osteoarthritis: Biomarkers.Osteoarthritis and cartilage · 2022
    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

8 authors.

Anne Sofie Siebuhr
Anne C Bay-Jensen
Diana J Leeming
Adam Plat
Inger Byrjalsen
Claus Christiansen
Désirée van de Heijde
Morten A Karsdal

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRheumatoid arthritis (RA) patients with structural progression are in most need of immediate treatment to maintain tissue integrity. The serum protein fingerprint, type I collagen degradation mediated by matrix metalloproteinases (MMP)-cleavage (C1M), is a biomarker of tissue destruction. We investigated whether baseline serum C1M levels could identify structural progressors and if the biomarker levels changed during anti-inflammatory treatment with tocilizumab (TCZ).

methodsThe LITHE-biomarker study (NCT00106535, n = 585) was a one-year phase III, double-blind, placebo (PBO)-controlled, parallel group study of TCZ 4 or 8 mg/kg every four weeks, in RA patients on stable doses of methotrexate (MTX). Spearman's ranked correlation was used to assess the correlation between baseline C1M levels and structural progression at baseline and at weeks 24 and 52. Multivariate regression was performed for delta structural progression. Change in C1M levels were studied as a function of time and treatment.

resultsAt baseline, C1M was significantly correlated to C-reactive protein (P <0.0001), visual analog scale pain (P <0.0001), disease activity score28-erythrocyte sedimentation rate (DAS28-ESR) (P <0.0001), joint space narrowing (JSN) (P = 0.0056) and modified total Sharp score (mTSS) (P = 0.0006). Baseline C1M was significantly correlated with delta-JSN at Week 24 (R² = 0.09, P = 0.0001) and at Week 52 (R² = 0.27, P <0.0001), and with delta-mTSS at 24 weeks (R² = 0.006, P = 0.0015) and strongly at 52 weeks (R² = 0.013, P <0.0001) in the PBO group. C1M levels were dose-dependently reduced in the TCZ + MTX group.

conclusionsBaseline C1M levels correlated with worsening joint structure over one year. Serum C1M levels may enable identification of those RA patients that are in most need of aggressive treatment

trial registrationClinicalTrials.gov: NCT00106535.

Indexed as

Antibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidBiomarkersCollagen Type IDisease ProgressionDouble-Blind MethodEnzyme-Linked Immunosorbent AssayFemaleHumansMaleMiddle AgedOdds RatioPeptide FragmentsRadiographyAntibodies, Monoclonal, HumanizedAntirheumatic AgentsBiomarkersCollagen Type IPeptide Fragmentstocilizumab

Identifiers

PMID23945134
PMCPMC3978450

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.