Trial reportNeurology2009
GLANCE: results of a phase 2, randomized, double-blind, placebo-controlled study.
Trial report in Neurology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 4 of them syntheses that pooled 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.
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.
Who cites it
40 citing papers in PubMed, 4 syntheses or guidelines pooled it, 129 citations in OpenAlex.
- Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis.The Cochrane database of systematic reviews · 2023Pooled it
- Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.The Cochrane database of systematic reviews · 2015Pooled it
- Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis.The Cochrane database of systematic reviews · 2013Pooled it
- Glatiramer acetate for multiple sclerosis.The Cochrane database of systematic reviews · 2010Pooled it
- Rituximab vs placebo induction prior to glatiramer acetate monotherapy in multiple sclerosis.Neurology · 2019Trial
- MRI outcomes with cladribine tablets for multiple sclerosis in the CLARITY study.Journal of neurology · 2013Trial
- Review
- Advances in Therapeutics Research for Demyelinating Diseases.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Evolving understanding of autoimmune mechanisms and new therapeutic strategies of autoimmune disorders.Signal transduction and targeted therapy · 2024Review
- Review
- Monoclonal Antibody Therapies for Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder.Journal of clinical neurology (Seoul, Korea) · 2020Review
- Enduring Clinical Value of Copaxone® (Glatiramer Acetate) in Multiple Sclerosis after 20 Years of Use.Multiple sclerosis international · 2019Review
- Natalizumab: Perspectives from the Bench to Bedside.Cold Spring Harbor perspectives in medicine · 2018Review
- Review
- Natalizumab in Multiple Sclerosis: Long-Term Management.International journal of molecular sciences · 2017Review
- Catastrophic outcome of patients with a rebound after Natalizumab treatment discontinuation.Brain and behavior · 2017Article
- The use of natalizumab for multiple sclerosis.Neuropsychiatric disease and treatment · 2017Review
- Comparative efficacy of first-line natalizumab vs IFN-β or glatiramer acetate in relapsing MS.Neurology. Clinical practice · 2016Article
- Monoclonal antibody therapies for the treatment of relapsing-remitting multiple sclerosis: differentiating mechanisms and clinical outcomes.Therapeutic advances in neurological disorders · 2015Review
- An update on the use of natalizumab in the treatment of multiple sclerosis: appropriate patient selection and special considerations.Patient preference and adherence · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 1 institution in 2 countries.
Funding
Abstract
objectiveTo evaluate the safety and tolerability of natalizumab when added to glatiramer acetate (GA) in patients with relapsing multiple sclerosis. The primary outcome assessed whether this combination would increase the rate of development of new active lesions on cranial MRI scans vs GA alone.
methodsThis phase 2, randomized, double-blind, placebo-controlled study included patients aged 19 to 55 years who were treated with GA for at least 1 year before randomization and experienced at least one relapse during the previous year. Patients received IV natalizumab 300 mg (n = 55) or placebo (n = 55) once every 4 weeks plus GA 20 mg subcutaneously once daily for < or = 20 weeks.
resultsThe mean rate of development of new active lesions was 0.03 with combination therapy vs 0.11 with GA alone (p = 0.031). Combination therapy resulted in lower mean numbers of new gadolinium-enhancing lesions (0.6 vs 2.3 for GA alone, p = 0.020) and new/newly enlarging T2-hyperintense lesions (0.5 vs 1.3, p = 0.029). The incidence of infection and infusion reactions was similar in both groups; no hypersensitivity reactions were observed. One serious adverse event occurred with combination therapy (elective hip surgery). With the exception of an increase in anti-natalizumab antibodies with combination therapy, laboratory data were consistent with previous clinical studies of natalizumab alone.
conclusionThe combination of natalizumab and glatiramer acetate seemed safe and well tolerated during 6 months of therapy.
Indexed as
Identifiers
What OpenQuestion holds
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.