Treatments Against RA and Effect on FDG-PET/CT

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Brigham and Women's Hospital
Study ID
NCT02374021
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate — DRUG
    Subjects entering trial will continue on MTX dose of at least 15mg MTX/week. At the discretion of the treating rheumatologist, may be switched to SQ route.
  • Sulfasalazine — DRUG
    1 gm bid
  • Hydroxychloroquine — DRUG
    200 mg twice daily, not to exceed 6.5mg/kg
  • Etanercept — DRUG
    50 mg SC weekly
  • Adalimumab — DRUG
    40 mg SQ every other week

Study Details

In a randomized controlled clinical trial, investigators will compare the effects on \[18F\]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate responders (MTX-IRs). Two common RA treatments will be compared: triple therapy (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF) inhibitor (etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening).

Key Dates

Start date
Jul 31, 2016
Status verified
Oct 2022
Primary completion
May 31, 2021
Completion
May 31, 2021

Study Design

Enrollment
159 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Triple therapy (MTX+SSZ+HCQ)
    Sulfasalazine (SSZ) 1 g bid and hydroxychloroquine (HCQ) 200 mg twice daily, not to exceed 6.5mg/kg HCQ (in addition to concomitant methotrexate \[MTX\]).
  • Active Comparator: TNF inhibitor (etanercept or adalimumab)
    etanercept 50 mg subcutaneously weekly or adalimumab 40 mg subcutaneously every other week (in addition to concomitant methotrexate, plus hydroxychloroquine, for subjects who were taking this at screening). Biologic treatment will be assigned randomly.

Primary Outcome Measure

Change From Baseline in Vascular Inflammation as Measured by FDG-PET/CT at 6 Months [ Time Frame: 0, 6 months ]

Locations (31)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Loma Linda University Clinical Trial CenterLoma LindaCalifornia92354-
David Geffen School of Medicine at UCLALos AngelesCalifornia90095-
Brigid Freyne, MD Inc.MurrietaCalifornia92563-
Desert Medical AdvancesPalm DesertCalifornia92260-
University of California San FranciscoSan FranciscoCalifornia94110-
Nazanin Firooz MD, Inc.West HillsCalifornia91307-
Robert W. Levin, MD, PAClearwaterFlorida33765-
IRIS Research and DevelopmentPlantationFlorida33324-
Southwest Florida Clinical Research CenterTampaFlorida33609-
University of KentuckyLexingtonKentucky40508-
The Center for Rheumatology and Bone ResearchWheatonMaryland20902-
Brigham and Women's HospitalBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
Washington University Medical CenterSt LouisMissouri63110-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Northwell HealthGreat NeckNew York11021-
Columbia University Medical CenterNew YorkNew York10032-
Mount Sinai- Icahn School of MedicineNew YorkNew York10029-
New York University School of MedicineNew YorkNew York10003-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Cleveland ClinicClevelandOhio44195-
Oregon Health & Science UniversityPortlandOregon97329-
Altoona Research CenterDuncansvillePennsylvania16635-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical CenterPittsburghPennsylvania15261-
Metroplex Clinical Research CenterDallasTexas75231-
University of Texas Health Science Center at HoustonHoustonTexas77030-
Baylor Scott & White Medical Center- TempleTempleTexas76508-
Seattle Rheumatology AssociatesSeattleWashington98122-

Find similar trials in Birmingham, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
University of Alabama at Birmingham· Birmingham, ALLoma Linda University Clinical Trial Center· Loma Linda, CADavid Geffen School of Medicine at UCLA· Los Angeles, CABrigid Freyne, MD Inc.· Murrieta, CADesert Medical Advances· Palm Desert, CAUniversity of California San Francisco· San Francisco, CA

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