Evidence map›Paper›PMID 27430352›Full record

ArticleBMC neurology2016

Rationale, design, and methods of a non-interventional study to establish safety, effectiveness, quality of life, cognition, health-related and work capacity data on Alemtuzumab in multiple sclerosis patients in Germany (TREAT-MS).

Tjalf Ziemssen, Ulrich Engelmann, Sigbert Jahn, Alexandra Leptich, Raimar Kern, Lina Hassoun, Katja Thomas

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in BMC neurology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.9field-weighted citation impact, top 9% 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

16 citing papers in PubMed, 25 citations in OpenAlex.

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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

7 authors at 2 institutions in 1 country.

Tjalf ZiemssenCenter of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany. Tjalf.Ziemssen@uniklinikum-dresden.de.ORCID http://orcid.org/0000-0001-8799-8202
Ulrich EngelmannMedical Affairs, Genzyme GmbH, Neu-Isenburg, Germany.
Sigbert JahnMedical Affairs, Genzyme GmbH, Neu-Isenburg, Germany.
Alexandra LeptichClinical Study Unit, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
Raimar KernCenter of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany.
Lina HassounCenter of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany.
Katja ThomasCenter of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany.
University Hospital Carl Gustav Carus · DESanofi (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlemtuzumab, a humanized monoclonal antibody directed against the cell surface glycoprotein CD52, is licensed in Europe since October 2013 as treatment for adult patients with active relapsing-remitting multiple sclerosis (RRMS). In three randomized, rater-blinded active comparator clinical trials studies, alemtuzumab administered in two annual courses, had superior efficacy as compared to subcutaneous interferon beta-1a, and durable efficacy over 5 years in an extension study with a manageable safety profile in RRMS patients. Data on the utilization and the outcomes of alemtuzumab under clinical practice conditions are limited.

methodsHere we describe the rationale, design and methods of the TREAT-MS study (non-interventional long-Term study foR obsErvAtion of Treatment with alemtuzumab in active relapsing-remitting MS). DISCUSSION: TREAT-MS is a prospective, multicenter, non-interventional, long-term study to collect data on safety, effectiveness, quality of life, cognition and other aspects from 3200 RRMS patients treated with alemtuzumab under the conditions of real-world clinical practice in Germany.

trial registrationAs non-interventional trial in Germany.

Indexed as

Quality of LifeAdultAlemtuzumabAntibodies, Monoclonal, HumanizedCognitionGermanyHumansMultiple Sclerosis, Relapsing-RemittingProspective StudiesRecurrenceAlemtuzumabAntibodies, Monoclonal, HumanizedAlemtuzumabMSDS3DMultiple sclerosisNon-interventional trialReal worl dataRisk-management plan

Identifiers

PMID27430352
PMCPMC4950609
OpenAlexW2495537355

What OpenQuestion holds

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LicenceCC BY
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.