Evidence map›Paper›PMID 35019731›Full record

ArticleNeurodegenerative disease management2022

Side effects that occurred early in people with multiple sclerosis during the first year of treatment with cladribine tablets: a plain language summary.

Jiwon Oh, Bryan Walker, Gavin Giovannoni, Dominic Jack, Fernando Dangond, Axel Nolting, Julie Aldridge, Lori A Lebson, Thomas P Leist

2 registry-linked trialsOpen access · hybridAbstract readCommentPatient Education Handout
PubMed Publisher
In one paragraph

Article in Neurodegenerative disease management, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.5field-weighted citation impact, top 37% 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.

NCT00213135 phase3completednot on this map

A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)

TypeinterventionalSponsorEMD SeronoRan2005 to 2008Enrolled1,326ConditionsMultiple Sclerosis, Relapsing-RemittingArmsCladribine 5.25 mg/kg, Cladribine 3.5 mg/kg, Placebo
NCT00725985 phase3completednot on this map

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Oral Cladribine in Subjects With a First Clinical Event at High Risk of Converting to MS

TypeinterventionalSponsorEMD Serono Research & Development Institute, Inc.Ran2008 to 2012Enrolled617ConditionsMultiple SclerosisArmsCladribine, Placebo, Rebif® new formulation (RNF)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 3 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 5 countries.

Jiwon OhDivision of Neurology, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, Canada.
Bryan WalkerDepartment of Neurology, Duke University School of Medicine, Durham, NC, USA.
Gavin GiovannoniBlizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Dominic JackMerck Serono Ltd., Feltham, UK, an affiliate of Merck KGaA.
Fernando DangondEMD Serono Research and Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA.
Axel NoltingMerck Healthcare KGaA, Darmstadt, Germany.
Julie AldridgeEMD Serono Research and Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA.
Lori A LebsonEMD Serono, Inc., Rockland, MA, USA, an affiliate of Merck KGaA.
Thomas P LeistComprehensive Multiple Sclerosis Center, Jefferson University, Philadelphia, PA, USA.
Merck Serono (Italy) · ITDuke University · USMerck (Germany) · DEMerck (United Kingdom) · GBMultiple Sclerosis Research Institute · USQueen Mary University of London · GBUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

People with multiple sclerosis (also shortened to MS) may have difficulties staying on treatment due to side effects. Cladribine tablets, approved for treating relapsing forms of MS, are given by mouth for four short periods over two years. The benefit of convenient dosing may be lost if side effects prevent people with MS from finishing their treatment. This is the summary of a study that examined side effects from cladribine tablets treatment in the first 12 weeks of two clinical studies called CLARITY and ORACLE-MS. Overall, 34.7% of participants who took cladribine tablets experienced drug-related side effects compared to 23.2% of participants who took placebo. Most side effects were mild and were seen in 54.8% of participants taking cladribine tablets and 59.1% taking the placebo. A low number of participants discontinued treatment due to side effects (1.6% of participants who took cladribine tablets; 1.4% of participants who took placebo). The researchers concluded that cladribine tablets are well-tolerated and people with MS are likely to complete the full treatment course. ClinicalTrials.gov NCT numbers: CLARITY study - NCT00213135 and ORACLE-MS study - NCT00725985.

Indexed as

CladribineMultiple SclerosisHumansImmunosuppressive AgentsLanguageTabletsCladribineImmunosuppressive AgentsTabletscladribine tabletsCLARITYlay summarymultiple sclerosisORACLE-MSplain language summaryside effects

Identifiers

PMID35019731
OpenAlexW4206167951

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.