Evidence map›Paper›PMID 21083889›Full record

Trial reportArthritis research & therapy2010

Association of serum markers with improvement in clinical response measures after treatment with golimumab in patients with active rheumatoid arthritis despite receiving methotrexate: results from the GO-FORWARD study.

Sudha Visvanathan, Mahboob U Rahman, Edward Keystone, Mark Genovese, Lars Klareskog, Elizabeth Hsia, Michael Mack, Jacqui Buchanan, Michael Elashoff, Carrie Wagner

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2010. 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 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.0field-weighted citation impact, top 14% 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.

NCT00264550 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Subjects With ActiveRheumatoid Arthritis Despite Methotrexate Therapy

TypeinterventionalSponsorCentocor, Inc.Ran2005 to 2012Enrolled444ConditionsRheumatoid ArthritisArmsGolimumab 100 mg, Golimumab 50 mg, Methotrexate, Placebo injection, Placebo capsules
NCT02878161 phase4unknown statusnot on this mapstarted 2016, after this paper: background citation

Screening Protein Predictive of Response to Tumor Necrosis Factor-α Inhibitors Treatment in Chinese Rheumatoid Arthritis From "Real World" and Investigating Its Mechanism Through Signal Pathway

TypeinterventionalSponsorFen LiRan2016 to 2019Enrolled240ConditionsRheumatoid ArthritisArmsmethotrexate(necessary), infliximab, etanercept, adalimumab, leflunomide (permitted, not necessary)
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 34 citations in OpenAlex.

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  13. Golimumab for Rheumatoid Arthritis.Journal of clinical medicine · 2019
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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 at 5 institutions in 3 countries.

Sudha VisvanathanCentocor Research and Development, Inc, 200 Great Valley Parkway, Malvern, PA 19355, USA.
Mahboob U Rahman
Edward Keystone
Mark Genovese
Lars Klareskog
Elizabeth Hsia
Michael Mack
Jacqui Buchanan
Michael Elashoff
Carrie Wagner
University of Pennsylvania · USJohnson & Johnson (United States) · USKarolinska Institutet · SEMount Sinai Hospital · CAStanford University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe goal of this study was to identify serum markers that are modulated by treatment with golimumab with or without methotrexate (MTX) and are associated with clinical response.

methodsSera were collected at weeks 0 and 4 from a total of 336 patients (training dataset, n = 100; test dataset, n = 236) from the GO-FORWARD study of patients with active rheumatoid arthritis despite MTX. Patients were randomly assigned to receive placebo plus MTX; golimumab, 100 mg plus placebo; golimumab, 50 mg plus MTX; or golimumab, 100 mg plus MTX. Subcutaneous injections were administered every 4 weeks. Samples were tested for select inflammatory, bone, and cartilage markers and for protein profiling using multianalyte profiles.

resultsTreatment with golimumab with or without MTX resulted in significant decreases in a variety of serum proteins at week 4 as compared with placebo plus MTX. The American College of Rheumatology (ACR) 20, ACR 50, and Disease Activity Score (DAS) 28 responders showed a distinct biomarker profile compared with nonresponding patients.

conclusionsACR 20 and ACR 50 responders among the golimumab/golimumab + MTX-treated patients had a distinct change from baseline to week 4 in serum protein profile as compared with nonresponders. Some of these changed markers were also associated with multiple clinical response measures and improvement in outcome measures in golimumab/golimumab + MTX-treated patients. Although the positive and negative predictive values of the panel of markers were modest, they were stronger than C-reactive protein alone in predicting clinical response to golimumab.

trial registrationhttp://ClinicalTrials.gov identification number: NCT00264550.

Indexed as

Antibodies, MonoclonalAntirheumatic AgentsArthritis, RheumatoidBiomarkersEnzyme-Linked Immunosorbent AssayHumansMethotrexateAntibodies, MonoclonalAntirheumatic AgentsBiomarkersgolimumabMethotrexate

Identifiers

PMID21083889
PMCPMC3046519
OpenAlexW2157198188

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.