Evidence map›Paper›PMID 19066176›Full record

Trial reportAnnals of the rheumatic diseases2009

Golimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study.

E C Keystone, M C Genovese, L Klareskog, E C Hsia, S T Hall, P C Miranda, J Pazdur, S-C Bae, W Palmer, J Zrubek and 5 more

Erratum issuedOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 207 papers, 31 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
207citing papers in PubMed, 31 pooled it
27.8field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

207 citing papers in PubMed, 31 syntheses or guidelines pooled it, 537 citations in OpenAlex.

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  14. Biologic interventions for fatigue in rheumatoid arthritis.The Cochrane database of systematic reviews · 2016
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147 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 7 institutions in 6 countries.

E C KeystoneUniversity of Toronto and Mount Sinai Hospital, Ontario, Canada. edkeystone@mtsinai.on.ca
M C Genovese
L Klareskog
E C Hsia
S T Hall
P C Miranda
J Pazdur
S-C Bae
W Palmer
J Zrubek
M Wiekowski
S Visvanathan
Z Wu
M U Rahman
GO-FORWARD Study
University of Pennsylvania · USCabrini Hospital · AUHanyang University Seoul Hospital · KRKarolinska University Hospital · SEMount Sinai Hospital · CAPalo Alto University · USUniversity of Chile · CL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe phase III GO-FORWARD study examined the efficacy and safety of golimumab in patients with active rheumatoid arthritis (RA) despite methotrexate therapy.

methodsPatients were randomly assigned in a 3 : 3 : 2 : 2 ratio to receive placebo injections plus methotrexate capsules (group 1, n = 133), golimumab 100 mg injections plus placebo capsules (group 2, n = 133), golimumab 50 mg injections plus methotrexate capsules (group 3, n = 89), or golimumab 100 mg injections plus methotrexate capsules (group 4, n = 89). Injections were administered subcutaneously every 4 weeks. The co-primary endpoints were the proportion of patients with 20% or greater improvement in the American College of Rheumatology criteria (ACR20) at week 14 and the change from baseline in the health assessment questionnaire-disability index (HAQ-DI) score at week 24.

resultsThe proportion of patients who achieved an ACR20 response at week 14 was 33.1% in the placebo plus methotrexate group, 44.4% (p = 0.059) in the golimumab 100 mg plus placebo group, 55.1% (p = 0.001) in the golimumab 50 mg plus methotrexate group and 56.2% (p<0.001) in the golimumab 100 mg plus methotrexate group. At week 24, median improvements from baseline in HAQ-DI scores were 0.13, 0.13 (p = 0.240), 0.38 (p<0.001) and 0.50 (p<0.001), respectively. During the placebo-controlled portion of the study (to week 16), serious adverse events occurred in 2.3%, 3.8%, 5.6% and 9.0% of patients and serious infections occurred in 0.8%, 0.8%, 2.2% and 5.6%, respectively.

conclusionThe addition of golimumab to methotrexate in patients with active RA despite methotrexate therapy significantly reduced the signs and symptoms of RA and improved physical function.

Indexed as

Acute DiseaseAdultAnalysis of VarianceAntibodies, MonoclonalArthritis, RheumatoidBacterial InfectionsChi-Square DistributionDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansImmunosuppressive AgentsInjections, SubcutaneousMaleMethotrexateAntibodies, MonoclonalgolimumabImmunosuppressive AgentsMethotrexateTumor Necrosis Factor-alpha

Identifiers

PMID19066176
PMCPMC2674549
OpenAlexW2158058290

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.