Evidence map›Paper›PMID 38585373›Full record

ArticleTherapeutic advances in neurological disorders2024

Cladribine tablets after treatment with natalizumab (CLADRINA) - rationale and design.

Peter V Sguigna, Rehana Z Hussain, Annette Okai, Kyle M Blackburn, Lauren Tardo, Mariam Madinawala, Julie Korich, Lori A Lebson, Jeffrey Kaplan, Amber Salter and 2 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Therapeutic advances in neurological disorders, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

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

3 citing papers in PubMed.

  1. The Art of Sequencing Disease-Modifying Therapies in Multiple Sclerosis.Neurology(R) neuroimmunology & neuroinflammation · 2026
    Review
  2. Review
  3. Article
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

12 authors.

Peter V SguignaDepartment of Neurology, University of Texas Southwestern Medical Center, Dallas, TX, USA.ORCID https://orcid.org/0000-0003-1825-575X
Rehana Z HussainDepartment of Neurology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Annette OkaiNorth Texas Institute of Neurology & Headache, Plano, TX, USA.
Kyle M BlackburnDepartment of Neurology, University of Texas Southwestern Medical Center, Dallas, TX, USA.ORCID https://orcid.org/0000-0001-5227-153X
Lauren TardoDepartment of Neurology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Mariam MadinawalaDepartment of Neurology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Julie KorichEMD Serono, Inc., Rockland, MA, USA, an affiliate of Merck KGaA, Darmstadt, Germany.
Lori A LebsonEMD Serono, Inc., Rockland, MA, USA, an affiliate of Merck KGaA, Darmstadt, Germany.
Jeffrey KaplanKansas City Multiple Sclerosis and Headache Center, Overland Park, KS, USA.
Amber SalterDepartment of Neurology, University of Texas Southwestern Medical Center, Dallas, TX, USA.ORCID https://orcid.org/0000-0002-1088-110X
Navid ManouchehriDepartment of Neurology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Olaf StuveDepartment of Neurology, University of Texas Southwestern Medical Center, 6000 Harry Hines Blvd, Dallas, TX 75390-8813, USA.ORCID https://orcid.org/0000-0002-0469-6872

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Individual disease modifying therapies approved for multiple sclerosis (MS) have limited effectiveness and potentially serious side effects, especially when administered over long periods. Sequential combination therapy is a plausible alternative approach. Natalizumab is a monoclonal therapeutic antibody that reduces leukocyte access to the central nervous system that is associated with an increased risk of progressive multifocal leukoencephalopathy and disease reactivation after its discontinuation. Cladribine tablets act as a synthetic adenosine analog, disrupting DNA synthesis and repair, thereby reducing the number of lymphocytes. The generation of prospective, rigorous safety, and efficacy data in transitioning from natalizumab to cladribine is an unmet clinical need. Objectives: To test the feasibility of transitioning patients with relapsing forms of MS natalizumab to cladribine tablets. Design: Cladribine tablets after treatment with natalizumab (CLADRINA) is an open-label, single-arm, multicenter, collaborative phase IV, research study that will generate hypothesis regarding the safety, efficacy, and immunological impact of transition from natalizumab to cladribine tablets in patients with relapsing forms of MS. Methods and analysis: Participants will be recruited from three different sites. The primary endpoint is the absolute and percent change from baseline of lymphocytes and myeloid cell subsets, as well as blood neurofilament light levels. The secondary endpoint is the annualized relapse rate over the 12- and 24-month trial periods. Exploratory endpoints include the expanded disability status scale, and magnetic resonance imaging outcomes. Discussion: The CLADRINA trial will generate data regarding the safety, efficacy, and immunological impact of the transition from natalizumab to cladribine. As the pace of immunological knowledge of MS continues, insight into disease modifying therapy transition strategies is needed.

Indexed as

cladribine tabletsmultiple sclerosisnatalizumabneurofilament light chainprogressive multifocal leukoencephalopathy

Identifiers

PMID38585373
PMCPMC10996356

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.