Evidence map›Paper›PMID 24013647›Full record

Trial reportAnnals of the rheumatic diseases2014

Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study.

R Landewé, J Braun, A Deodhar, M Dougados, W P Maksymowych, P J Mease, J D Reveille, M Rudwaleit, D van der Heijde, C Stach and 5 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 216 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
216citing papers in PubMed, 14 pooled it
37.8field-weighted citation impact, top 1% 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.

NCT01087762 phase3completednot on this map

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

TypeinterventionalSponsorUCB BIOSCIENCES GmbHRan2010 to 2015Enrolled325ConditionsSpondyloarthropathiesArmsCZP 200 mg Q2W, CZP 400 mg Q4W, Placebo
NCT05517031 unknown statusnot on this mapstarted 2023, after this paper: background citation

Unmet Needs of Axial Spondyloarthrits in Egyptian Patients

TypeobservationalSponsorSohag UniversityRan2023 to 2023Enrolled100ConditionsAxial SpondyloarthritisArmsASDAS score , VAS score, BASFI score , Katz ADL index
3 · Its place in the literature

Who cites it

216 citing papers in PubMed, 14 syntheses or guidelines pooled it, 464 citations in OpenAlex.

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156 more citing papers are in PubMed but not listed here.

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

15 authors at 11 institutions in 6 countries.

R LandewéAcademic Medical Center Amsterdam & Atrium Medical Center Heerlen, , Amsterdam, The Netherlands.
J Braun
A Deodhar
M Dougados
W P Maksymowych
P J Mease
J D Reveille
M Rudwaleit
D van der Heijde
C Stach
B Hoepken
A Fichtner
G Coteur
M de Longueville
J Sieper
UCB Pharma (Belgium) · BECharité - Universitätsmedizin Berlin · DEEndokrinologikum · DEHôpital Cochin · FRLeiden University Medical Center · NLOregon Health & Science University · USRheumazentrum Ruhrgebiet · DEThe University of Texas Health Science Center at Houston · USUCB Pharma (Germany) · DEUniversity of Alberta · CAUniversity of Washington · US

Funding

Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
NCATS NIH HHS UL1 TR000371
6 · The paper itself

Abstract

objectivesTo evaluate the efficacy and safety of certolizumab pegol (CZP) after 24 weeks in RAPID-axSpA (NCT01087762), an ongoing Phase 3 trial in patients with axial spondyloarthritis (axSpA), including patients with ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA).

methodsPatients with active axSpA were randomised 1:1:1 to placebo, CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg every 4 weeks (Q4W). In total 325 patients were randomised. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society 20) response at week 12. Secondary outcomes included change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Metrology Index (BASMI) linear.

resultsBaseline disease activity was similar between AS and nr-axSpA. At week 12, ASAS20 response rates were significantly higher in CZP 200 mg Q2W and CZP 400 mg Q4W arms versus placebo (57.7 and 63.6 vs 38.3, p≤0.004). At week 24, combined CZP arms showed significant (p<0.001) differences in change from baseline versus placebo in BASFI (-2.28 vs -0.40), BASDAI (-3.05 vs -1.05), and BASMI (-0.52 vs -0.07). Improvements were observed as early as week 1. Similar improvements were reported with CZP versus placebo in both AS and nr-axSpA subpopulations. Adverse events were reported in 70.4% vs 62.6%, and serious adverse events in 4.7% vs 4.7% of All CZP versus placebo groups. No deaths or malignancies were reported.

conclusionsCZP rapidly reduced the signs and symptoms of axSpA, with no new safety signals observed compared to the safety profile of CZP in RA. Similar improvements were observed across CZP dosing regimens, and in AS and nr-axSpA patients.

Indexed as

AdultAntibodies, Monoclonal, HumanizedCertolizumab PegolDouble-Blind MethodFemaleHumansImmunoglobulin Fab FragmentsImmunosuppressive AgentsMaleMiddle AgedPlacebosPolyethylene GlycolsSpondylarthritisSpondylitis, AnkylosingTreatment OutcomeAntibodies, Monoclonal, HumanizedCertolizumab PegolImmunoglobulin Fab FragmentsImmunosuppressive AgentsPlacebosPolyethylene Glycols

Identifiers

PMID24013647
PMCPMC3888598
OpenAlexW2134009713

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.