Evidence map›Paper›PMID 21415050›Full record

Trial reportAnnals of the rheumatic diseases2011

Certolizumab pegol plus methotrexate provides broad relief from the burden of rheumatoid arthritis: analysis of patient-reported outcomes from the RAPID 2 trial.

Vibeke Strand, Josef S Smolen, Ronald F van Vollenhoven, Philip Mease, Gerd R Burmester, Falk Hiepe, Dinesh Khanna, Enkeleida Nikaï, Geoffroy Coteur, Michael Schiff

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00160602 (A Phase III Multi-center, Double-blind, Placebo-controlled, Parallel Group 24-Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate.), which is not on this map. Cited by 31 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 5 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.

NCT00160602 phase3completednot on this map

A Phase III Multi-center, Double-blind, Placebo-controlled, Parallel Group 24-Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate.

TypeinterventionalSponsorUCB PharmaRan2005 to 2006Enrolled590ConditionsRheumatoid ArthritisArmsCertolizumab Pegol
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. 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

10 authors.

Vibeke StrandDivision of Immunology and Rheumatology, Stanford University, 306 Ramona Road, Portola Valley, CA 94028, USA. vstrand@stanford.edu
Josef S Smolen
Ronald F van Vollenhoven
Philip Mease
Gerd R Burmester
Falk Hiepe
Dinesh Khanna
Enkeleida Nikaï
Geoffroy Coteur
Michael Schiff

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the impact of certolizumab pegol (CZP) on patient-reported outcomes (PROs) in rheumatoid arthritis (RA), and to interpret these results using number needed to treat (NNT), and associations between PRO responses and longer term outcomes.

methodsA total of 619 patients with active RA were randomised to CZP 200 or 400 mg, or placebo plus methotrexate (MTX). PROs assessed included pain, patient's global assessment of disease activity (PtGA), physical function, fatigue and health-related quality of life. Treatment impact on PROs, NNT to achieve simultaneous improvements in multiple PROs and correlations between PROs were calculated. Times to onset of improvements greater than or equal to minimum clinically important differences (MCIDs) in pain as a determinant of clinical outcomes at week 24 were compared between week 6 and 12 responders, and in patients with improvements in pain ≥ MCID at week 12 (week 12 responders/non-responders).

resultsCZP 200 and 400 mg plus MTX were associated with rapid, clinically meaningful improvements in all PROs. The NNT for subjects to report changes ≥MCID in up to five PROs was two to three, and five for all six PROs (pain, PtGA, physical function, fatigue and short-form 36-item Physical and Mental Component Summary Scores). More patients with improvements ≥MCID in pain at week 6 than those at week 12 had lower disease activity at week 24. Week 12 pain responders had better clinical outcomes at week 24 than non-responders.

conclusionsThe data demonstrate that CZP provides broad relief from the burden of RA. Trial registration number NCT00160602.

Indexed as

AdultAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidCertolizumab PegolDose-Response Relationship, DrugDrug Administration ScheduleDrug Therapy, CombinationEpidemiologic MethodsFatigueFemaleHumansImmunoglobulin Fab FragmentsMaleMethotrexateMiddle AgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsCertolizumab PegolImmunoglobulin Fab FragmentsMethotrexatePolyethylene Glycols

Identifiers

PMID21415050
PMCPMC3086050

What OpenQuestion holds

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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.