Evidence map›Paper›PMID 30043210›Full record

Trial reportAdvances in therapy2018

Clinical, Ultrasound, and Predictability Outcomes Following Certolizumab Pegol Treatment (with Methotrexate) in Patients with Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results from the CZP-SPEED Study.

Piercarlo Sarzi-Puttini, Emilio Filippucci, Silvano Adami, Pier Luigi Meroni, Alberto Batticciotto, Luca Idolazzi, Orazio De Lucia, Pablo Talavera, Thomas Kumke, Walter Grassi

Registry-linked trialOpen access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Advances in therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01443364 (Multicenter, Open Label Study to Evaluate the Predictability of Early Response to Certolizumab Pegol), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 26% 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.

NCT01443364 phase4completednot on this map

Multicenter, Open Label Study to Evaluate the Predictability of Early Response to Certolizumab Pegol (in Combination With Methotrexate) as Confirmed at Week 52 in Subjects With Moderate-severe Rheumatoid Arthritis (RA)

TypeinterventionalSponsorUCB Italy s.p.a.Ran2011 to 2015Enrolled132ConditionsRheumatoid ArthritisArmsCertolizumab pegol
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 18 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Observational
  6. Review
  7. 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

10 authors at 7 institutions in 3 countries.

Piercarlo Sarzi-PuttiniAzienda Ospedaliera Luigi Sacco Polo Universitario, Milan, Italy.
Emilio FilippucciUniversità Politecnica delle Marche, Ancona, Italy.
Silvano AdamiUniversità degli Studi di Verona, Azienda Ospedaliera di Verona, Verona, Italy.
Pier Luigi MeroniASST Centro Ortopedico Traumatologico Gaetano Pini-CTO-Università degli Studi di Milano, Milan, Italy.
Alberto BatticciottoAzienda Ospedaliera Luigi Sacco Polo Universitario, Milan, Italy.
Luca IdolazziUniversità degli Studi di Verona, Azienda Ospedaliera di Verona, Verona, Italy.
Orazio De LuciaASST Centro Ortopedico Traumatologico Gaetano Pini-CTO-Università degli Studi di Milano, Milan, Italy.
Pablo TalaveraUCB Pharma, Madrid, Spain.
Thomas KumkeUCB Pharma, Monheim, Germany.
Walter GrassiUniversità Politecnica delle Marche, Ancona, Italy. walter.grassi@univpm.it.
Marche Polytechnic University · ITAzienda Ospedaliera Universitaria Integrata Verona · ITIstituto Ortopedico Gaetano Pini · ITUCB Pharma (Germany) · DEUCB Pharma (Spain) · ESUniversity of Milan · ITUniversity of Verona · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo assess the impact of certolizumab pegol (CZP) treatment on clinical, patient-reported, and musculoskeletal ultrasound outcomes and to determine the treatment response time point most predictive of long-term outcomes in Italian patients with rheumatoid arthritis (RA).

methodsCZP-SPEED (NCT01443364) was a 52-week, open-label, prospective, interventional, multicenter study. Biologic-naïve patients with moderate-to-severe active RA, who had failed at least one DMARD treatment, received CZP (400 mg at weeks 0, 2, and 4, then 200 mg every 2 weeks) concomitantly with methotrexate. The primary objective was to identify the time point of clinical response {decrease in 28-joint Disease Activity Score [DAS28(ESR)] ≥ 1.2} most predictive of a clinical response at week 52. Additional clinical and patient-reported outcomes were measured. Power Doppler (PD) ultrasound was used to assess synovial effusion, synovial proliferation, PD signal, cartilage damage, and bone erosion according to international guidelines.

resultsA total of 132 patients were enrolled and received CZP; 91/132 (69%) completed to week 52. Predicted 52-week responses for early responders (week 2 onwards) were between 65% and 70%. Rapid improvements in joint cavity widening and PD signal were observed to week 8 and maintained to week 52. Cartilage damage and bone erosion were stable over 52 weeks. No new safety signals were identified.

conclusionIn Italian CZP-treated patients with moderate-to-severe RA, week 12 clinical responses may be predictive of long-term response at week 52. Rapid improvements in clinical, patient-reported, and musculoskeletal ultrasound outcomes were maintained to week 52. These data may aid rheumatologists to make earlier treatment decisions.

trial registrationClinicalTrials.gov identifier, NCT01443364.

fundingUCB Pharma.

Indexed as

AdultAgedAntirheumatic AgentsArthritis, RheumatoidCertolizumab PegolDrug Therapy, CombinationFemaleHumansMaleMethotrexateMiddle AgedProspective StudiesSeverity of Illness IndexTreatment OutcomeAntirheumatic AgentsCertolizumab PegolMethotrexateAnti-TNFCertolizumab pegolPatient-reported outcomePredictabilityRheumatoid arthritisRheumatologyUltrasound

Identifiers

PMID30043210
PMCPMC6096970
OpenAlexW2884117710

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.