2022
The CELLO trial: Protocol of a planned phase 4 study to assess the efficacy of Ocrelizumab in patients with radiologically isolated syndrome
Longbrake EE, Hua LH, Mowry EM, Gauthier SA, Alvarez E, Cross AH, Pei J, Priest J, Raposo C, Hafler DA, Winger RC. The CELLO trial: Protocol of a planned phase 4 study to assess the efficacy of Ocrelizumab in patients with radiologically isolated syndrome. Multiple Sclerosis And Related Disorders 2022, 68: 104143. PMID: 36031693, PMCID: PMC9772048, DOI: 10.1016/j.msard.2022.104143.Peer-Reviewed Original ResearchConceptsEfficacy of ocrelizumabMultiple sclerosisImmunologic biomarkersClinical trialsTransient B-cell depletionClinical multiple sclerosisCSF immune cellsEffects of ocrelizumabMS disease pathophysiologyNew brain lesionsOvert neurological symptomsB-cell depletionPlacebo-controlled studyPhase 4 studyLong-term outcomesPatient-reported outcomesPrimary progressive MSHumanized monoclonal antibodyFirst-degree relativesB cell biologySubtle cognitive impairmentEligible patientsImmune recoveryProgressive MSWeek 48
2010
A Randomized Controlled Double-Masked Trial of Albuterol Add-on Therapy in Patients With Multiple Sclerosis
Khoury SJ, Healy BC, Kivisäkk P, Viglietta V, Egorova S, Guttmann CR, Wedgwood JF, Hafler DA, Weiner HL, Buckle G, Cook S, Reddy S. A Randomized Controlled Double-Masked Trial of Albuterol Add-on Therapy in Patients With Multiple Sclerosis. JAMA Neurology 2010, 67: 1055-1061. PMID: 20837847, PMCID: PMC2954052, DOI: 10.1001/archneurol.2010.222.Peer-Reviewed Original ResearchMeSH KeywordsAdjuvants, ImmunologicAdrenergic beta-AgonistsAdultAlbuterolDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleGlatiramer AcetateHumansInterferon-gammaInterleukin-13Logistic ModelsMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingOdds RatioPeptidesPilot ProjectsTreatment OutcomeConceptsMultiple Sclerosis Functional CompositeRelapsing-remitting multiple sclerosisGlatiramer acetateMultiple sclerosisClinical trialsAlbuterol groupTime pointsOral doseIL-13Subcutaneous injectionHelper T-cell subtypes 1Double-masked clinical trialGlatiramer acetate treatmentImmunologic end pointsMasked clinical trialEffects of albuterolIL-12 expressionIL-13 productionStudy time pointsΒ2-adrenergic agonistAlbuterol treatmentAcetate therapyAdverse eventsFirst relapseImmunologic effects
1997
Treatment of Uveitis by Oral Administration of Retinal Antigens: Results of a Phase I/II Randomized Masked Trial
Nussenblatt R, Gery I, Weiner H, Ferris F, Shiloach J, Remaley N, Perry C, Caspi R, Hafler D, Foster C, Whitcup S. Treatment of Uveitis by Oral Administration of Retinal Antigens: Results of a Phase I/II Randomized Masked Trial. American Journal Of Ophthalmology 1997, 123: 583-592. PMID: 9152063, DOI: 10.1016/s0002-9394(14)71070-0.Peer-Reviewed Original ResearchConceptsPhase I/IISoluble retinal antigenTreatment of uveitisRetinal antigensRetinal S-antigenS-antigenStudy endpointImmunosuppressive therapyOral administrationPhase I/II studyMasked trialOcular inflammatory attacksStandard immunosuppressive therapySystemic immunosuppressive therapyPrimary study endpointSecondary study endpointsMain study endpointImmunosuppressive medicationsII studyInflammatory attacksOcular inflammationCytotoxic medicationsImmunosuppressive agentsEndogenous uveitisTreatment groups
1996
Three‐year Open Protocol Continuation Study of Oral Tolerization with Myelin Antigens in Multiple Sclerosis and Design of a Phase III Pivotal Trial
HOHOL M, KHOURY S, COOK S, ORAV E, HAFLER D, WEINER H. Three‐year Open Protocol Continuation Study of Oral Tolerization with Myelin Antigens in Multiple Sclerosis and Design of a Phase III Pivotal Trial. Annals Of The New York Academy Of Sciences 1996, 778: 243-250. PMID: 8610977, DOI: 10.1111/j.1749-6632.1996.tb21132.x.Peer-Reviewed Original Research
1993
Effects of Oral Administration of Type II Collagen on Rheumatoid Arthritis
Trentham D, Dynesius-Trentham R, Orav E, Combitchi D, Lorenzo C, Sewell K, Hafler D, Weiner H. Effects of Oral Administration of Type II Collagen on Rheumatoid Arthritis. Science 1993, 261: 1727-1730. PMID: 8378772, DOI: 10.1126/science.8378772.Peer-Reviewed Original ResearchConceptsRheumatoid arthritisType II collagenT cell-mediated autoimmune diseaseCell-mediated autoimmune diseaseChicken type II collagenII collagenActive rheumatoid arthritisDouble-blind trialOral tolerizationTender jointsTolerization approachComplete remissionSwollen jointsClinical efficacySynovial diseaseAutoimmune diseasesPotential autoantigensOral administrationT cellsArthritisSide effectsAnimal modelsDiseaseCollagen groupPatientsDouble-Blind Pilot Trial of Oral Tolerization with Myelin Antigens in Multiple Sclerosis
Weiner H, Mackin G, Matsui M, Orav E, Khoury S, Dawson D, Hafler D. Double-Blind Pilot Trial of Oral Tolerization with Myelin Antigens in Multiple Sclerosis. Science 1993, 259: 1321-1324. PMID: 7680493, DOI: 10.1126/science.7680493.Peer-Reviewed Original ResearchConceptsMultiple sclerosisOral tolerizationMyelin antigensAutoimmune diseasesDouble-blind pilot trialRelapsing-remitting multiple sclerosisDouble-blind studyCentral nervous systemMyelin basic proteinMajor exacerbationsDaily capsuleT cellsT lymphocytesPilot trialSide effectsNervous systemControl groupMyelin componentsBovine myelinDiseaseMyelinTolerizationSclerosisAntigenBasic protein