Evidence map›Paper›PMID 17299059›Full record

Trial reportGut2007

Adalimumab for maintenance treatment of Crohn's disease: results of the CLASSIC II trial.

W J Sandborn, S B Hanauer, P Rutgeerts, R N Fedorak, M Lukas, D G MacIntosh, R Panaccione, D Wolf, J D Kent, B Bittle and 2 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gut, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 325 papers, 23 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
325citing papers in PubMed, 23 pooled it
41.5field-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

325 citing papers in PubMed, 23 syntheses or guidelines pooled it, 1,030 citations in OpenAlex.

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  15. Adalimumab for maintenance of remission in Crohn's disease.The Cochrane database of systematic reviews · 2020
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  18. Adalimumab for induction of remission in Crohn's disease.The Cochrane database of systematic reviews · 2019
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265 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 5 countries.

W J SandbornMayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. sandborn.william@mayo.edu
S B Hanauer
P Rutgeerts
R N Fedorak
M Lukas
D G MacIntosh
R Panaccione
D Wolf
J D Kent
B Bittle
J Li
P F Pollack
Abbott (United Kingdom) · GBAtlanta Diabetes Associates · USCharles University · CZDalhousie University · CAMayo Clinic · USUniversitair Ziekenhuis Leuven · BEUniversity of Alberta · CAUniversity of Calgary · CAUniversity of Illinois Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdalimumab induced clinical remission after four weeks in patients with active Crohn's disease in the CLASSIC I trial.

objectiveTo evaluate long term efficacy and safety of adalimumab maintenance therapy in Crohn's disease in a follow-on randomised controlled trial (CLASSIC II).

methodsIn the preceding CLASSIC I trial, 299 patients with moderate to severe Crohn's disease naive to tumour necrosis factor antagonists received induction therapy with adalimumab 40 mg/20 mg, 80 mg/40 mg, or 160 mg/80 mg, or placebo, at weeks 0 and 2. In all, 276 patients from CLASSIC I enrolled in CLASSIC II and received open-label adalimumab 40 mg at weeks 0 (week 4 of CLASSIC I) and 2; 55 patients in remission at both weeks 0 and 4 were re-randomised to adalimumab 40 mg every other week, 40 mg weekly, or placebo for 56 weeks. Patients not in remission at both weeks 0 and 4 were enrolled in an open-label arm and received adalimumab 40 mg every other week. With non-response or flare, these patients could have their dosages increased to 40 mg weekly. Patients in the randomised arm with continued non-response or disease flare could switch to open-label adalimumab 40 mg every other week and again to 40 mg weekly. The primary end point was maintenance of remission (CDAI <150) in randomised patients through week 56.

resultsOf 55 patients randomised at week 4, 79% who received adalimumab 40 mg every other week and 83% who received 40 mg weekly were in remission at week 56, v 44% for placebo (p<0.05). In all, 204 patients entered the open-label arm. Of these, 93 (46%) were in clinical remission at week 56. Adalimumab was generally well-tolerated in all patients.

conclusionsAdalimumab induced and maintained clinical remission for up to 56 weeks in patients with moderate to severe Crohn's disease naive to anti-TNF treatment.

Indexed as

AdalimumabAdultAntibodiesAntibodies, AntinuclearAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnti-Inflammatory AgentsCrohn DiseaseDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansImmunosuppressive AgentsInjections, SubcutaneousLong-Term CareAdalimumabAntibodiesAntibodies, AntinuclearAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnti-Inflammatory AgentsImmunosuppressive Agents

Identifiers

PMID17299059
PMCPMC2701613
OpenAlexW2137775651

What OpenQuestion holds

Textmetadata
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.