Evidence map›Paper›PMID 24754273›Full record

Trial reportModern rheumatology2014

Phase III, multicenter, open-label, long-term study of the safety of abatacept in Japanese patients with rheumatoid arthritis and an inadequate response to conventional or biologic disease-modifying antirheumatic drugs.

Tsutomu Takeuchi, Tsukasa Matsubara, Yukitomo Urata, Eiichi Suematsu, Shuji Ohta, Shigeru Honjo, Tohru Abe, Ami Yamamoto, Nobuyuki Miyasaka, Japan Abatacept Study Group

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Modern rheumatology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00484289 (A Phase III, Multi-center, Open-label, Uncontrolled, Long-term Study to Evaluate the Safety of Abatacept), which is not on this map. Cited by 5 papers.

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

NCT00484289 phase3completednot on this map

A Phase III, Multi-center, Open-label, Uncontrolled, Long-term Study to Evaluate the Safety of Abatacept (BMS-188667) in Japanese Subjects With Rheumatoid Arthritis Having Completed Clinical Studies IM101-071, IM101-034, and Also Special DMARD Failures

TypeinterventionalSponsorBristol-Myers SquibbRan2006 to 2010Enrolled217ConditionsRheumatoid ArthritisArmsAbatacept
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Co-stimulation Therapy in Rheumatoid Arthritis: Today and Tomorrow.Current treatment options in rheumatology · 2015
    Review
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.

Tsutomu TakeuchiDivision of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University , Tokyo , Japan.
Tsukasa Matsubara
Yukitomo Urata
Eiichi Suematsu
Shuji Ohta
Shigeru Honjo
Tohru Abe
Ami Yamamoto
Nobuyuki Miyasaka
Japan Abatacept Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo examine the long-term safety of intravenous (IV) abatacept treatment in Japanese patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX) or other conventional or biologic disease-modifying antirheumatic drugs.

methodsThis Phase III, open-label, long-term study (NCT00484289) comprised Japanese patients with RA who had completed abatacept Phase I or Phase II studies, and new patients intolerant to MTX. Patients from Phase I and Phase II studies received a weight-tiered dosing equivalent of 10 mg/kg abatacept, with MTX at doses up to 8 mg/week; newly enrolled patients received weight-tiered 10 mg/kg abatacept monotherapy. Safety and efficacy were assessed.

resultsA total of 217 patients (Phase I, n = 13; Phase II, n = 178; newly enrolled, n = 26) were treated with IV abatacept for a mean of 3 years. Serious adverse events occurred in 67/217 (30.9%) patients. Most adverse events were mild or moderate. For all cohorts combined, American College of Rheumatology 20% response rates ranged from 61.3 to 81.8% for as-observed and last observation carried forward analyses over 192 weeks. Following initial response, clinical and functional outcomes were maintained for up to 3 years.

conclusionsIn Japanese patients with RA, IV abatacept with and without background MTX showed tolerable safety and sustained efficacy over 3 years.

Indexed as

AbataceptAdultAgedAntirheumatic AgentsArthritis, RheumatoidBiological ProductsFemaleHumansImmunoconjugatesJapanMaleMiddle AgedQuality of LifeRetreatmentTreatment OutcomeAbataceptAntirheumatic AgentsBiological ProductsImmunoconjugatesabataceptJapaneselong-term studyrheumatoid arthritis

Identifiers

PMID24754273
PMCPMC4162652

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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.