Evidence map›Paper›PMID 26139005›Full record

Trial reportAnnals of the rheumatic diseases2016

The first double-blind, randomised, parallel-group certolizumab pegol study in methotrexate-naive early rheumatoid arthritis patients with poor prognostic factors, C-OPERA, shows inhibition of radiographic progression.

Tatsuya Atsumi, Kazuhiko Yamamoto, Tsutomu Takeuchi, Hisashi Yamanaka, Naoki Ishiguro, Yoshiya Tanaka, Katsumi Eguchi, Akira Watanabe, Hideki Origasa, Shinsuke Yasuda and 9 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01451203 (A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Patients With Early-stage Rheumatoid Arthritis Who Are Naïve to Methotrexate and Have Poor Prognostic Factors), which is not on this map. Cited by 54 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 12 pooled it
9.1field-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.

NCT01451203 phase3completednot on this map

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Patients With Early-stage Rheumatoid Arthritis Who Are Naïve to Methotrexate and Have Poor Prognostic Factors

TypeinterventionalSponsorAstellas Pharma IncRan2011 to 2014Enrolled319ConditionsRheumatoid ArthritisArmsPlacebo, CZP, methotrexate (MTX)
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 12 syntheses or guidelines pooled it, 110 citations in OpenAlex.

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  12. Certolizumab pegol (CDP870) for rheumatoid arthritis in adults.The Cochrane database of systematic reviews · 2017
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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

19 authors at 17 institutions in 2 countries.

Tatsuya AtsumiHokkaido University Graduate School of Medicine, Sapporo, Japan.
Kazuhiko YamamotoThe University of Tokyo, Tokyo, Japan.
Tsutomu TakeuchiKeio University School of Medicine, Tokyo, Japan.
Hisashi YamanakaTokyo Women's Medical University, Tokyo, Japan.
Naoki IshiguroFaculty of Medicine, Nagoya University Graduate School, Nagoya, Japan.
Yoshiya TanakaUniversity of Occupational and Environmental Health, Kitakyushu, Japan.
Katsumi EguchiSasebo Chuo Hospital, Nagasaki, Japan.
Akira WatanabeTohoku University, Sendai, Japan.
Hideki OrigasaUniversity of Toyama School of Medicine, Toyama, Japan.
Shinsuke YasudaHokkaido University Graduate School of Medicine, Sapporo, Japan.
Yuji YamanishiHiroshima Rheumatology Clinic, Hiroshima, Japan.
Yasuhiko KitaYokohama Rosai Hospital, Yokohama, Japan.
Tsukasa MatsubaraMatsubara Mayflower Hospital, Kato, Japan.
Masahiro IwamotoJichi Medical University, Tochigi, Japan.
Toshiharu ShojiUCB Pharma, Tokyo, Japan.
Toshiyuki OkadaAstellas Pharma Inc., Tokyo, Japan.
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands.ORCID http://orcid.org/0000-0002-5781-158X
Nobuyuki MiyasakaTokyo Medical and Dental University, Tokyo, Japan.
Takao KoikeHokkaido University Graduate School of Medicine, Sapporo, Japan NTT Sapporo Medical Centre, Sapporo, Japan.
Hokkaido University · JPAstellas Pharma (Japan) · JPJichi Medical University · JPKeio University · JPLeiden University Medical Center · NLMatsubara Mayflower Hospital · JPNagoya University · JPSapporo Medical University · JPSasebo City General Hospital · JPThe University of Tokyo · JPTohoku University · JPTokyo Medical and Dental University · JPTokyo Women's Medical University · JPUCB Pharma (Japan) · JPUniversity of Occupational and Environmental Health Japan · JPUniversity of Toyama · JPYokohama Rosai Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate efficacy and safety of combination therapy using certolizumab pegol (CZP) and methotrexate (MTX) as first-line treatment for MTX-naive, early rheumatoid arthritis (RA) with poor prognostic factors, compared with MTX alone.

methodsMTX-naive, early RA patients with ≤12 months persistent disease, high anti-cyclic citrullinated peptide, and either rheumatoid factor positive and/or presence of bone erosions were enrolled in this multicentre, double-blind, randomised placebo (PBO)-controlled study. Patients were randomised 1:1 to CZP+MTX or PBO+MTX for 52 weeks. Primary endpoint was inhibition of radiographic progression (change from baseline in modified Total Sharp Score (mTSS CFB)) at week 52. Secondary endpoints were mTSS CFB at week 24, and clinical remission rates at weeks 24 and 52.

results316 patients randomised to CZP+MTX (n=159) or PBO+MTX (n=157) had comparable baseline characteristics reflecting features of early RA (mean disease duration: 4.0 vs 4.3 months; Disease Activity Score 28-joint assessment (DAS28)) (erythrocyte sedimentation rate (ESR)): 5.4 vs 5.5; mTSS: 5.2 vs 6.0). CZP+MTX group showed significantly greater inhibition of radiographic progression relative to PBO+MTX at week 52 (mTSS CFB=0.36 vs 1.58; p<0.001) and week 24 (mTSS CFB=0.26 vs 0.86; p=0.003). Clinical remission rates (Simple Disease Activity Index, Boolean and DAS28 (ESR)) of the CZP+MTX group were significantly higher compared with those of the PBO+MTX group, at weeks 24 and 52. Safety results in both groups were similar, with no new safety signals observed with addition of CZP to MTX.

conclusionsIn MTX-naive early RA patients with poor prognostic factors, CZP+MTX significantly inhibited structural damage and reduced RA signs and symptoms, demonstrating the efficacy of CZP in these patients. TRIAL REGISTRATION NUMBER: (NCT01451203).

Indexed as

AdultAntibodiesAntirheumatic AgentsArthritis, RheumatoidBlood SedimentationCertolizumab PegolDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMethotrexateMiddle AgedPeptides, CyclicPrognosisRadiographyAntibodiesAntirheumatic AgentsCertolizumab Pegolcyclic citrullinated peptideMethotrexatePeptides, CyclicRheumatoid FactorAnti-TNFDisease ActivityEarly Rheumatoid ArthritisInflammationRheumatoid Arthritis

Identifiers

PMID26139005
PMCPMC4717398
OpenAlexW2262742107

What OpenQuestion holds

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LicenceCC BY-NC
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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.