Evidence map›Paper›PMID 24431394›Full record

Trial reportAnnals of the rheumatic diseases2015

Certolizumab pegol in rheumatoid arthritis patients with low to moderate activity: the CERTAIN double-blind, randomised, placebo-controlled trial.

J S Smolen, P Emery, G F Ferraccioli, W Samborski, F Berenbaum, O R Davies, W Koetse, O Purcaru, B Bennett, H Burkhardt

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00674362 (A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis), which is not on this map. Cited by 48 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 10 pooled it
–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.

NCT00674362 phase3completednot on this map

A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis

TypeinterventionalSponsorUCB PharmaRan2008 to 2010Enrolled194ConditionsRheumatoid ArthritisArmsCertolizumab pegol, Placebo
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Pooled it
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  5. Certolizumab pegol (CDP870) for rheumatoid arthritis in adults.The Cochrane database of systematic reviews · 2017
    Pooled it
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  17. Work productivity in Behçet syndrome.EULAR rheumatology open · 2026
    Article
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  19. Review
  20. 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.

J S SmolenDivision of Rheumatology, Department of Medicine 3, Medical University of Vienna, and 2nd Department of Medicine, Hietzing Hospital, Vienna, Austria.
P EmeryLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, Leeds, UK NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
G F FerraccioliInstitute of Rheumatology and Affine Sciences, Catholic University of the Sacred Heart, Rome, Italy.
W SamborskiUniversity of Medical Sciences, Poznan, Poland.
F BerenbaumDepartment of Rheumatology, DHU i2B, INSERM UMR-S938, Pierre & Marie Curie University Paris 06, Saint-Antoine hospital, AP-HP, Paris, France.
O R DaviesUCB Pharma, Brussels, Belgium.
W KoetseUCB Pharma, Raleigh, North Carolina, USA.
O PurcaruUCB Pharma, Brussels, Belgium.
B BennettBABennett Consulting, Marietta, USA.
H BurkhardtCIRI/Division of Rheumatology and Fraunhofer TMP, Goethe-University, Frankfurt am Main, Germany.

Funding

Arthritis Research UK 18475
6 · The paper itself

Abstract

objectivesThis 52-week, randomised, double-blind phase IIIb study assessed efficacy and safety of certolizumab pegol (CZP) as add-on therapy to non-biologic disease-modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis (RA) patients with low to moderate disease activity, and stopping therapy in patients in sustained remission.

methodsPatients were randomised 1:1 to CZP (400 mg at weeks 0, 2 and 4, then 200 mg every 2 weeks) or placebo (every 2 weeks) plus current non-biologic DMARDs. At week 24, patients who achieved the primary endpoint of Clinical Disease Activity Index (CDAI) remission at both weeks 20 and 24 stopped study treatment and continued in the study until week 52.

resultsOf 194 patients (CZP=96; placebo=98), >90% had moderate disease activity at baseline. Significantly more CZP patients met the primary endpoint than placebo patients (week 20 and 24 CDAI remission rates: 18.8% vs 6.1%; p≤0.05). At week 24, 63.0% vs 29.7% of CZP versus placebo patients (p<0.001) achieved LDA. Disease activity score (ESR) based on 28-joint count and Simplified Disease Activity Index remission rates were also significantly higher with CZP versus placebo (19.8% vs 3.1%; p≤0.01 and 14.6% vs 4.1%; p≤0.05). CZP patients reported improvements in physical function versus placebo (mean Health Assessment Questionnaire-Disability-Index change from baseline: CZP, -0.25 vs placebo, -0.03; p≤0.01). During the period following withdrawal of CZP or placebo, only 3/17 prior CZP patients and 2/6 prior placebo patients maintained CDAI remission until week 52, but CZP reinstitution allowed renewed improvement. Adverse and serious adverse event rates were comparable between CZP and placebo groups.

conclusionsAddition of CZP to non-biologic DMARDs is an effective treatment in RA patients with predominantly moderate disease activity, allowing low-disease activity or remission to be reached in a majority of the patients. However, the data suggest that CZP cannot be withdrawn in patients achieving remission. TRIAL REGISTRATION NUMBER: NCT00674362.

Indexed as

AdolescentAdultAgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidCertolizumab PegolDouble-Blind MethodDrug Therapy, CombinationFemaleHumansImmunoglobulin Fab FragmentsImmunosuppressive AgentsMaintenance ChemotherapyMaleMethotrexateAntibodies, Monoclonal, HumanizedAntirheumatic AgentsCertolizumab PegolImmunoglobulin Fab FragmentsImmunosuppressive AgentsMethotrexatePolyethylene GlycolsAnti-TNFDisease ActivityDMARDs (biologic)Rheumatoid Arthritis

Identifiers

PMID24431394
PMCPMC4392224

What OpenQuestion holds

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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.