BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Yale University
Study ID
NCT02110706
Phase
PHASE2
Status
Completed

Conditions

  • Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
21 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Intervention (rituximab): The treatment group will receive a total of two cycles of rituximab separated by 6 months. Each cycle is defined as one infusion (375mg/m2 IV) per week for four consecutive weeks
  • Placebo — DRUG
    The placebo group will receive a vehicle control infusion

Study Details

The specific primary objective of this study is to determine whether rituximab is a safe and beneficial therapeutic for Myasthenia Gravis (MG) that warrants further study in a phase III efficacy trial.

Key Dates

Start date
May 31, 2014
Status verified
Mar 2020
Primary completion
Jul 31, 2017
Completion
May 31, 2018

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    The placebo group will receive a vehicle control infusion
  • Experimental: Rituximab
    Intervention (rituximab): The treatment group will receive a total of two cycles of rituximab separated by 6 months. Each cycle is defined as one infusion (375mg/m2 IV) per week for four consecutive weeks

Primary Outcome Measure

Steroid Sparing Effect [ Time Frame: 4 weeks prior baseline and 4 weeks prior to week 52 ]

Locations (26)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
University of California - DavisDavisCalifornia95616-
University of California - Los AngelesLos AngelesCalifornia90095-
University of Colorado - DenverDenverColorado80217-
Yale School of Medicine, Department of NeurologyNew HavenConnecticut06510-
University of Miami School of MedicineMiamiFlorida33136-
Emory UniversityAtlantaGeorgia30322-
Northwestern UniversityEvanstonIllinois60208-
University of Kansas Medical CenterKansas CityKansas66160-
Brigham & Women's HospitalBostonMassachusetts02115-
Washington UniversitySt LouisMissouri63130-
SUNY Downstate Medical CenterBrooklynNew York11203-
SUNY BuffaloBuffaloNew York14260-
Columbia University Medical CenterNew YorkNew York10032-
Weill Cornell Medical CenterNew YorkNew York10065-
University of RochesterRochesterNew York14627-
SUNY Stony BrookStony BrookNew York11790-
Montefiore Medical CenterThe BronxNew York10461-
University of CincinnatiCincinnatiOhio45220-
Ohio State UniversityColumbusOhio43210-
Oregon Health and Science UniversityPortlandOregon97239-
University of PittsburghPittsburghPennsylvania15260-
University of Texas Southwestern Medical CenterDallasTexas75235-
University of UtahSalt Lake CityUtah84112-
University of VirginiaCharlottesvilleVirginia22904-
Swedish Medical CenterSeattleWashington98107-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of California - Davis· Davis, CAUniversity of California - Los Angeles· Los Angeles, CAUniversity of Colorado - Denver· Denver, COYale School of Medicine, Department of Neurology· New Haven, CTUniversity of Miami School of Medicine· Miami, FL

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