Evidence map›Paper›PMID 28090798›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2017

Switching from branded to generic glatiramer acetate: 15-month GATE trial extension results.

Krzysztof Selmaj, Frederik Barkhof, Anna N Belova, Christian Wolf, Evelyn Rw van den Tweel, Janine Jl Oberyé, Roel Mulder, David F Egging, Norbert P Koper, Jeffrey A Cohen and 1 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–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.

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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
  6. Multiple Sclerosis Medications in the VHA: Delivering Specialty, High-Cost, Pharmacy Care in a National System.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2020
    Article
  7. Review
  8. Article
  9. Follow-on glatiramer acetate.eNeurologicalSci · 2018
    Article
  10. Article
  11. Article
  12. Article
  13. A Comprehensive Review on CopemylNeurology and therapy · 2017
    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

11 authors.

Krzysztof SelmajNeurology Center Lodz, Lodz, Poland.
Frederik BarkhofImage Analysis Center, Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands/Institutes of Neurology & Healthcare Engineering, UCL, London, UK.
Anna N BelovaResearch Institute of Traumatology and Orthopedics, Functional Diagnostics, Nizhny Novgorod, Russia.
Christian WolfLycalis sprl, Brussels, Belgium.
Evelyn Rw van den TweelSynthon BV, Nijmegen, The Netherlands.
Janine Jl OberyéSynthon BV, Nijmegen, The Netherlands.
Roel MulderSynthon BV, Nijmegen, The Netherlands.
David F EggingSynthon BV, Nijmegen, The Netherlands.
Norbert P KoperSynthon BV, Nijmegen, The Netherlands.
Jeffrey A CohenMellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.
GATE study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOpen-label 15-month follow-up of the double-blind, placebo-controlled Glatiramer Acetate clinical Trial to assess Equivalence with Copaxone

objectiveTo evaluate efficacy, safety, and tolerability of prolonged generic glatiramer acetate (GTR) treatment and to evaluate efficacy, safety, and tolerability of switching from brand glatiramer acetate (GA) to GTR treatment.

methodsA total of 729 patients received GTR 20 mg/mL daily. Safety was assessed at months 12, 15, 18, 21, and 24 and Expanded Disability Status Scale and magnetic resonance imaging (MRI) scans at months 12, 18, and 24. The presence of glatiramer anti-drug antibodies (ADAs) was tested at baseline and months 1, 3, 6, 9, 12, 18, and 24.

resultsThe mean number of gadolinium-enhancing lesions in the GTR/GTR and GA/GTR groups was similar at months 12, 18, and 24. The change in other MRI parameters was also similar in the GTR/GTR and GA/GTR groups. The annualized relapse rate (ARR) did not differ between the GTR/GTR and GA/GTR groups, 0.21 and 0.24, respectively. The incidence, spectrum, and severity of reported adverse events did not differ between the GTR/GTR and GA/GTR groups. Glatiramer ADA titers were similar in the GTR/GTR and GA/GTR groups.

conclusionEfficacy and safety of GTR is maintained over 2 years. Additionally, switching from GA to GTR is safe and well tolerated.

Indexed as

Drug SubstitutionOutcome Assessment, Health CareAdultDouble-Blind MethodDrugs, GenericFemaleFollow-Up StudiesGlatiramer AcetateHumansImage EnhancementImmunosuppressive AgentsMagnetic Resonance ImagingMaleMiddle AgedMultiple SclerosisDrugs, GenericGlatiramer AcetateImmunosuppressive Agentsclinical trialequivalencegenericglatiramer acetateMultiple sclerosis

Identifiers

PMID28090798
PMCPMC5700775

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Registered trials

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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.