Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis

Part of paid clinical trials in Dothan, Alabama.

Sponsor
AbbVie
Study ID
NCT02065622
Phase
PHASE3
Status
Completed

Conditions

  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.

Key Dates

Start date
Mar 27, 2014
Status verified
Sep 2020
Primary completion
Sep 5, 2019
Completion
Nov 11, 2019

Study Design

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

Arms

  • Experimental: Induction (Main Study + Japan Sub-study): I-SD
    Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.
  • Experimental: Induction (Main Study + Japan Sub-study): I-HD
    Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4, and 40 mg at Week 6.
  • Experimental: Maintenance (Main Study + Japan Sub-study): M-SD
    Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.
  • Experimental: Maintenance (Main Study + Japan Sub-study): M-HD
    Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
  • Experimental: Maintenance (Main Study): TDM Regimen
    Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore (RBS) assessments.

Primary Outcome Measure

Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8 [ Time Frame: Week 8 ]

Locations (42)

FacilityCityStateZIPSite coordinators
Digestive Health Specialists of the Southeast /ID# 127844DothanAlabama36305-
Ucsd /Id# 122313La JollaCalifornia92093-
Rocky Mountain Clinical Resear /ID# 122180Wheat RidgeColorado80033-
Medical Research Ctr CT /ID# 122179HamdenConnecticut06518-
Gastro Florida /ID# 170619ClearwaterFlorida33756-
Research Associates of South Florida,LLC /ID# 170309MiamiFlorida33156-
Gastroenterology Group Naples /ID# 127806NaplesFlorida34102-
Shafran Gastroenterology Ctr /ID# 122320Winter ParkFlorida32789-
Atlanta Gastro Assoc /ID# 122336AtlantaGeorgia30342-
Gastro Assoc of Central GA /ID# 122318MaconGeorgia31201-
Northwestern University Feinberg School of Medicine /ID# 122183ChicagoIllinois60611-2927-
University of Chicago /ID# 122302ChicagoIllinois60637-1443-
Carle Foundation Hospital /ID# 135955UrbanaIllinois61801-
Louisiana Research Ctr. LLC /ID# 141655ShreveportLouisiana71105-6800-
University of Maryland Med Ctr /ID# 169734BaltimoreMaryland21201-
MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238Chevy ChaseMaryland20815-
University of Michigan Hospitals /ID# 122240Ann ArborMichigan48109-
Mayo Clinic - Rochester /ID# 122244RochesterMinnesota55905-0001-
Ctr for Digest and Liver Dis /ID# 122182MexicoMissouri65265-
NYU Langone Long Island CRA /ID# 122177Great NeckNew York11021-
Icahn School of Med Mt. Sinai /ID# 127047New YorkNew York10029-
Charlotte Gastro Hepatology /ID# 122235CharlotteNorth Carolina28207-
Wake Research Associates, LLC /ID# 122157RaleighNorth Carolina27612-
Consultants for Clinical Res /ID# 122304CincinnatiOhio45219-
Dayton Gastroenterology, Inc. /ID# 127804EnglewoodOhio45415-
Gastro United of Tulsa /ID# 125436TulsaOklahoma74135-
The Oregon Clinic- Gastro West /ID# 135273PortlandOregon97225-
University of Pittsburgh MC /ID# 122331PittsburghPennsylvania15260-
Erlanger Institute for Clinica /ID# 129009ChattanoogaTennessee37403-
Gastro One /ID# 122339GermantownTennessee38138-
Vanderbilt Univ Med Ctr /ID# 125496NashvilleTennessee37232-0011-
DHAT Research Institute /ID# 170616GarlandTexas75044-2208-
Biopharma Informatic Research /ID# 171150HoustonTexas77024-2420-
Austin Center for Clinical Research /ID# 125396PflugervilleTexas78660-
Texas Digestive Disease Consul /ID# 141677SouthlakeTexas76092-
Texas Digestive Disease Consul /ID# 141678SouthlakeTexas76092-
Advanced Research Institute /ID# 126147OgdenUtah84403-
University of Utah /ID# 122333Salt Lake CityUtah84112-5500-
New River Valley Research Inst /ID# 127801ChristiansburgVirginia24073-
University of Washington /ID# 169721SeattleWashington98109-
Froedtert & the Medical College of Wisconsin /ID# 122261MilwaukeeWisconsin53226-3522-
WI Center for Advanced Res /ID# 122178MilwaukeeWisconsin53215-

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Digestive Health Specialists of the Southeast· Dothan, ALUcsd· La Jolla, CARocky Mountain Clinical Resear· Wheat Ridge, COMedical Research Ctr CT· Hamden, CTGastro Florida· Clearwater, FLResearch Associates of South Florida,LLC· Miami, FL

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