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

November 19, 2020 updated by: AbbVie

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
952

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Hainburg An Der Donau, Austria, 2410
        • Ordination Hainburg an der Don /ID# 127185
      • Salzburg, Austria, 5020
        • Universitaetsklinik fuer Innere Medizin 1 /ID# 125944
      • St Veit An Der Glan, Austria, 9300
        • KH der Barmherzigen Brueder /ID# 127183
    • Oberoesterreich
      • Linz, Oberoesterreich, Austria, 4010
        • KH der Elisabethinen Linz GmbH /ID# 127184
    • Wien
      • Vienna, Wien, Austria, 1090
        • Medizinische Universitat Wien /ID# 127186
  • Belgium
      • Ghent, Belgium, 9000
        • AZ Sint-Lucas /ID# 127187
      • Leuven, Belgium, 3000
        • UZ Leuven /ID# 126739
      • Liege, Belgium, 4000
        • CHU de Liege /ID# 126740
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary /ID# 125715
      • Edmonton, Alberta, Canada, T6G 2X8
        • Zeidler Ledcor Centre /ID# 125713
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Winnipeg Regional Health Autho /ID# 125712
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Qe Ii Hsc /Id# 127045
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre /ID# 127055
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hosp.-Toronto /ID# 126590
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Asso /ID# 127075
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill Univ HC /ID# 127046
  • Czechia
      • Hradec Kralove, Czechia, 500 12
        • Hepato-Gastroenterologie HK s.r.o. /ID# 127188
      • Praha 9, Czechia, 190 00
        • ISCARE a.s. /ID# 127837
  • Denmark
      • Silkeborg, Denmark, 8600
        • Regionhospital Silkeborg /ID# 127190
    • Hovedstaden
      • Herlev, Hovedstaden, Denmark, 2730
        • Herlev Hospital /ID# 127191
  • France
      • Clermont Ferrand, France, 63100
        • CHU Estaing /ID# 127848
      • Dijon, France, 21000
        • CHU Dijon /ID# 127861
      • Grenoble, France, 38043
        • CHU de Grenoble - Albet Michal /ID# 127195
      • Montpellier Cedex 5, France, 34295
        • CHU Saint ELOI /ID# 169007
      • Nice, France, 06202
        • CHU de Nice /ID# 127193
      • SAINT-ETIENNE Cedex 1, France, 42270
        • CHU de Saint-Etienne, Hopital Nord /ID# 134490
      • Toulouse, France, 31059
        • Hopital Rangueil /ID# 127192
    • Hauts-de-France
      • Lille CEDEX, Hauts-de-France, France, 59045
        • CHRU Lille - Hôpital Claude Huriez /ID# 127197
    • Meurthe-et-Moselle
      • Vandoeuvre les Nancy CEDEX, Meurthe-et-Moselle, France, 54511
        • CHU NANCY - Hôpital Brabois Adultes /ID# 127196
    • Somme
      • Amiens CEDEX 1, Somme, France, 80054
        • CHU Amiens Picardie /ID# 127194
  • Germany
      • Berlin, Germany, 10117
        • Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 127203
      • Berlin, Germany, 10318
        • Mross, Berlin, DE /ID# 127201
      • Berlin, Germany, D-10825
        • Gastrostudien GbR /ID# 169246
      • Hamburg, Germany, 22559
        • Asklepios Westklinikum Hamburg /ID# 127198
      • Jena, Germany, 07747
        • Universitaetsklinikum Jena /ID# 127205
      • Leipzig, Germany, 04103
        • EUGASTRO GmbH /ID# 127202
      • Magdeburg, Germany, 39120
        • Universitatsklinikum Magdeburg /ID# 127200
      • Munster, Germany, 48159
        • Gastro Campus Research GbR /ID# 126743
    • Bayern
      • Ratisbon, Bayern, Germany, 93053
        • Universitatsklinik Regensburg /ID# 201265
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Universitatsklinikum Frankfurt /ID# 170300
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 127199
  • Hungary
      • Budapest, Hungary, 1124
        • Magyar Elhizastudomanyi KKft. /ID# 126589
      • Budapest, Hungary, 1136
        • Pannonia Maganorvosi Centrum Kft. /ID# 127207
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem /ID# 127208
    • Pecs
      • Pécs, Pecs, Hungary, 7624
        • Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 127209
  • Israel
      • Be'er Sheva, Israel, 84101
        • Soroka University Medical Center /ID# 127213
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital /ID# 127211
      • Rehovot, Israel, 76100
        • Kaplan Medical Center /ID# 127210
    • Tel-Aviv
      • Petakh Tikva, Tel-Aviv, Israel, 4941492
        • Rabin Medical Center /ID# 127212
      • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 201365
  • Italy
      • Brescia, Italy, 25123
        • Azienda Ospedaliera Spedali Civili /ID# 127236
      • Padova, Italy, 35128
        • Universita di Padova /ID# 127214
      • Palermo, Italy, 90146
        • Ospedali Riuniti Villa Sofia-C /ID# 129323
      • Rome, Italy, 00133
        • Policlinico Univ Tor Vergata /ID# 129321
      • San Giovanni Rotondo, Italy, 71013
        • IRCCS Casa Sollievo /ID# 127811
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • A.O.U. Policlinico S.Orsola-Malpighi /ID# 129322
    • Lazio
      • Rome, Lazio, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini /ID# 127216
      • Rome, Lazio, Italy, 00168
        • Policlinico Agostino Gemelli /ID# 127217
    • Lombardia
      • Milan, Lombardia, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 127138
    • Milano
      • Rozzano, Milano, Italy, 20089
        • IBD Center - IRCCS Istituto Clinico Humanitas /ID# 127215
  • Japan
      • Tokyo, Japan, 169-0073
        • Tokyo Yamate Medical Center /ID# 125201
    • Aichi
      • Nagoya, Aichi, Japan, 460-0022
        • Yokoyama IBD Clinic /ID# 151560
      • Nagoya-shi, Aichi, Japan, 467-8602
        • Nagoya City University Hospital /ID# 124517
    • Chiba
      • Sakura-shi, Chiba, Japan, 285-8741
        • Toho University Sakura Medical Center /ID# 124497
    • Fukuoka
      • Chikushino, Fukuoka, Japan, 818-8502
        • Fukuoka University Chikushi Hospital /ID# 124155
      • Fukuoka-shi, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital /ID# 124495
      • Kurume, Fukuoka, Japan, 839-0809
        • Hidaka Clinic of Coloproctology /ID# 125477
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital /ID# 125275
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital /ID# 124496
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124480
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0015
        • Aoyama Clinic /ID# 127836
      • Nishinomiya-shi, Hyogo, Japan, 663-8501
        • Hyogo College of Medicine College Hospital /Id# 127539
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan, 252-0375
        • Kitasato University Hospital /ID# 137694
      • Yokohama, Kanagawa, Japan, 220-0045
        • COLO-PROCTOLOGY CENTER Matsushima Clinic /ID# 148423
    • Kochi
      • Susaki-shi, Kochi, Japan, 785-8501
        • Susaki Kuroshio Hospital /ID# 125202
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 605-0981
        • Japanese Red Cross Kyoto Daiichi Hos /ID# 127540
    • Osaka
      • Takatsuki-shi, Osaka, Japan, 569-8686
        • Osaka Medical College Hospital /ID# 126451
    • Saitama
      • Kawagoe-shi, Saitama, Japan, 350-8550
        • Saitama Medical Center /ID# 128875
    • Shiga
      • Otsu-shi, Shiga, Japan, 520-2192
        • Shiga University of Medical Science Hospital /ID# 127675
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan, 430-0846
        • Hamamatsu South Hospital /ID# 124481
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Medical Hospital of Tokyo Medical and Dental University /ID# 128315
      • Minato-ku, Tokyo, Japan, 108-8642
        • Kitasato Univ Kitasato Inst Ho /ID# 127001
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Kyorin University Hospital /ID# 148184
    • Wakayama
      • Wakayama-shi, Wakayama, Japan, 641-8510
        • Wakayama Medical University /ID# 124635
  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Academisch Medisch Centrum /ID# 126741
  • Poland
      • Chojnice, Poland, 89-600
        • Centrum Medyczne LukaMed Joanna Luka /ID# 170302
      • Czestochowa, Poland, 42-200
        • Centrum Medyczne Sw. Lukaza /ID# 126515
      • Lodz, Poland, 91-347
        • Centrum Diagnostyczno Lecznicze Barska /ID# 170304
      • Pulawy, Poland, 24-100
        • KO-Med Centra Kliniczne Pulawy /ID# 127219
      • Warsaw, Poland, 03-580
        • NZOZ Vivamed /ID# 127218
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
        • Szpital Uniwersytecki Nr 2 im. dr J.Biziela w Bydgoszczy /ID# 127141
    • Lodzkie
      • Lodz, Lodzkie, Poland, 90-302
        • C.M. Szpital Swietej Rodziny /ID# 127838
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 00-635
        • Centrum Zdrowia MDM /ID# 170303
      • Warszawa, Mazowieckie, Poland, 02-653
        • Endoterapia PFG Sp. z.o.o. /ID# 126513
    • Pomorskie
      • Gdynia, Pomorskie, Poland, 81-338
        • Centrum Medyczne Pratia Gdynia /ID# 170301
    • Slaskie
      • Katowice, Slaskie, Poland, 40-659
        • NZOZ All-Medicus /ID# 128740
      • Tychy, Slaskie, Poland, 43-100
        • H-T.Centrum Medyczne-Endoterapia /ID# 170305
  • Romania
      • Brasov, Romania, 500283
        • CMDTA Neomed SRL /ID# 127142
      • Cluj, Romania, 400006
        • Spitalul Clinic Judetean de Urgenta /ID# 125418
      • Cluj, Romania, 400132
        • Tvm Med Serv Srl /Id# 127221
      • Oradea, Romania, 410167
        • Cabinet Medical Dr. Fratila SRL, Specialitatea Medicina Interna /ID# 127002
      • Zalau, Romania, 450117
        • Salvo-San-Ciobanca SRL /ID# 127140
    • Bucuresti
      • Sector 2, Bucuresti, Romania, 022328
        • Institutul Clinic Fundeni /ID# 127839
  • Slovakia
      • Bratislava, Slovakia, 831 04
        • Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 127222
      • Bratislava, Slovakia, 851 01
        • Gastroenterologicka Ambulancia /ID# 125632
      • Lucenec, Slovakia, 984 01
        • Vseobecna Nemocnica s poliklinikou Lucenec /ID# 127322
  • Spain
      • Alicante, Spain, 03550
        • Hospital General Universitario de Alicante /ID# 129261
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona /ID# 138147
      • Ferrol, Spain, 15405
        • Complejo Hospitalario Universitario de Ferrol /ID# 127840
      • Las Palmas de Gran Canaria, Spain, 35010
        • Hospital Univ Dr. Negrin /ID# 127841
      • Madrid, Spain, 28006
        • Hospital Univ de la Princesa /ID# 135828
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon /ID# 127224
      • Madrid, Spain, 28041
        • Hosp Univ 12 de Octubre /ID# 129257
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz /ID# 127223
      • València, Spain, 46010
        • Hosp Clin Univ de Valencia /ID# 170306
      • Zaragoza, Spain, 50009
        • Hosp Clin Univ Lozano Blesa /ID# 129255
  • Switzerland
    • Sankt Gallen
      • St. Gallen, Sankt Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen /ID# 127843
    • Zuerich
      • Zurich, Zuerich, Switzerland, 8006
        • University Hospital Zurich /ID# 127842
  • Ukraine
      • Kherson, Ukraine, 73000
        • Public Institution Kherson City Clinical Hospital named after le.le. Karabelesh /ID# 127233
      • Kiev, Ukraine, 04201
        • Municipal Clinical Hospital #8 /ID# 127235
      • Lviv, Ukraine, 79011
        • Lviv City Clinical Hospital NO.4 /ID# 127232
      • Zaporizhzhia, Ukraine, 69035
        • CNPE City Hospital No.6 of Zaporizhzhia City Counsil /ID# 127137
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61039
        • GI National Institute of Therapy named by L.T. Malaya /ID# 127231
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital /ID# 204801
      • Harrow, United Kingdom, HA1 3UJ
        • St. Mark's Hospital /ID# 127226
      • Hull, United Kingdom, HU8 9HE
        • Hull and East Yorkshire Hospitals NHS Trust /ID# 127225
      • Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust The John Radcliffe Hospital /ID# 129324
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital /ID# 127228
      • Wolverhampton, United Kingdom, WV10 0QP
        • The Royal Wolverhampton NHS Tr /ID# 127227
    • Hampshire
      • Winchester, Hampshire, United Kingdom, SO22 5DG
        • Royal Hampshire County Hosp /ID# 169250
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich Univ Hosp /ID# 127139
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists of the Southeast /ID# 127844
    • California
      • La Jolla, California, United States, 92093
        • Ucsd /Id# 122313
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Rocky Mountain Clinical Resear /ID# 122180
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Medical Research Ctr CT /ID# 122179
    • Florida
      • Clearwater, Florida, United States, 33756
        • Gastro Florida /ID# 170619
      • Miami, Florida, United States, 33156
        • Research Associates of South Florida,LLC /ID# 170309
      • Naples, Florida, United States, 34102
        • Gastroenterology Group Naples /ID# 127806
      • Winter Park, Florida, United States, 32789
        • Shafran Gastroenterology Ctr /ID# 122320
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastro Assoc /ID# 122336
      • Macon, Georgia, United States, 31201
        • Gastro Assoc of Central GA /ID# 122318
    • Illinois
      • Chicago, Illinois, United States, 60611-2927
        • Northwestern University Feinberg School of Medicine /ID# 122183
      • Chicago, Illinois, United States, 60637-1443
        • University of Chicago /ID# 122302
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital /ID# 135955
    • Louisiana
      • Shreveport, Louisiana, United States, 71105-6800
        • Louisiana Research Ctr. LLC /ID# 141655
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Med Ctr /ID# 169734
      • Chevy Chase, Maryland, United States, 20815
        • MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospitals /ID# 122240
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic - Rochester /ID# 122244
    • Missouri
      • Mexico, Missouri, United States, 65265
        • Ctr for Digest and Liver Dis /ID# 122182
    • New York
      • Great Neck, New York, United States, 11021
        • NYU Langone Long Island CRA /ID# 122177
      • New York, New York, United States, 10029
        • Icahn School of Med Mt. Sinai /ID# 127047
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastro Hepatology /ID# 122235
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC /ID# 122157
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Res /ID# 122304
      • Englewood, Ohio, United States, 45415
        • Dayton Gastroenterology, Inc. /ID# 127804
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Gastro United of Tulsa /ID# 125436
    • Oregon
      • Portland, Oregon, United States, 97225
        • The Oregon Clinic- Gastro West /ID# 135273
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh MC /ID# 122331
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Institute for Clinica /ID# 129009
      • Germantown, Tennessee, United States, 38138
        • Gastro One /ID# 122339
      • Nashville, Tennessee, United States, 37232-0011
        • Vanderbilt Univ Med Ctr /ID# 125496
    • Texas
      • Garland, Texas, United States, 75044-2208
        • DHAT Research Institute /ID# 170616
      • Houston, Texas, United States, 77024-2420
        • Biopharma Informatic Research /ID# 171150
      • Pflugerville, Texas, United States, 78660
        • Austin Center for Clinical Research /ID# 125396
      • Southlake, Texas, United States, 76092
        • Texas Digestive Disease Consul /ID# 141677
      • Southlake, Texas, United States, 76092
        • Texas Digestive Disease Consul /ID# 141678
    • Utah
      • Ogden, Utah, United States, 84403
        • Advanced Research Institute /ID# 126147
      • Salt Lake City, Utah, United States, 84112-5500
        • University of Utah /ID# 122333
    • Virginia
      • Christiansburg, Virginia, United States, 24073
        • New River Valley Research Inst /ID# 127801
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington /ID# 169721
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • WI Center for Advanced Res /ID# 122178
      • Milwaukee, Wisconsin, United States, 53226-3522
        • Froedtert & the Medical College of Wisconsin /ID# 122261

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy during Screening period.
  • Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite concurrent or prior treatment with a full and adequate course, in the opinion of the Investigator, with oral corticosteroids or immunosuppressants or both. Mayo Score is confirmed by central reader.

Exclusion Criteria:

  • Subject with Crohn's disease (CD) or indeterminate colitis (IC).
  • Current diagnosis of fulminant colitis and/or toxic megacolon.
  • Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
  • Chronic recurring infections or active tuberculosis (TB).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Placebo
Drug: Adalimumab
Other Names:
  • Humira
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.
Drug: Adalimumab
Other Names:
  • Humira
Experimental: Maintenance (Main Study + Japan Sub-study): M-SD
Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.
Other: Placebo
Drug: Adalimumab
Other Names:
  • Humira
Experimental: Maintenance (Main Study + Japan Sub-study): M-HD
Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Drug: Adalimumab
Other Names:
  • Humira
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.
Other: Placebo
Drug: Adalimumab
Other Names:
  • Humira

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8
Time Frame: Week 8
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
Week 8
Maintenance Period Primary Endpoint: Percentage of Week 8 Responders (Per FMS) With Clinical Remission (Per FMS) at Week 52
Time Frame: Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per FMS) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease from baseline in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Induction Period Ranked Secondary Endpoint 1: Percentage of Participants With Endoscopic Improvement at Week 8
Time Frame: Week 8
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Week 8
Induction Period Ranked Secondary Endpoint 2: Percentage of Participants With Fecal Calprotectin < 150 mg/kg at Week 8
Time Frame: Week 8
Week 8
Induction Period Ranked Secondary Endpoint 3: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response (Increase of IBDQ ≥ 16 From Baseline) at Week 8
Time Frame: Week 8
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.
Week 8
Induction Period Ranked Secondary Endpoint 4: Percentage of Participants With Clinical Response Per FMS at Week 8
Time Frame: Week 8
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical response is defined as a decrease in FMS of ≥ 3 points and ≥ 30% from baseline, plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1.
Week 8
Induction Period Ranked Secondary Endpoint 5: Percentage of Participants With Endoscopic Remission at Week 8
Time Frame: Week 8
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Endoscopic remission is defined as an endoscopy subscore of 0.
Week 8
Induction Period Ranked Secondary Endpoint 6: Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 8
Time Frame: Week 8
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score ≥ 6.
Week 8
Induction Period Ranked Secondary Endpoint 7: Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 8
Time Frame: Week 8
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The IBDQ Fatigue item score range is from 1 (severe problem) to 7 (normal health). Response is defined as an increase of IBDQ Fatigue item score ≥ 1.
Week 8
Maintenance Period Ranked Secondary Endpoint 1: Percentage of Week 8 Responders (Per FMS) With Endoscopic Improvement at Week 52
Time Frame: Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Week 52
Maintenance Period Ranked Secondary Endpoint 2: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52
Time Frame: Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders, per FMS, are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1.
Week 52
Maintenance Period Ranked Secondary Endpoint 3: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission at Week 52
Time Frame: Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders, per FMS, are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission is defined as FMS ≤ 2 with no subscore > 1.
Week 52
Maintenance Period Ranked Secondary Endpoint 4: Percentage of Week 8 Remitters (Per FMS) With Clinical Remission (Per FMS) at Week 52
Time Frame: Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopy subscore provided by the central reader.
Week 52
Maintenance Period Ranked Secondary Endpoint 5: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Improvement at Week 52
Time Frame: Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. Endoscopy subscore provided by the central reader.
Week 52
Maintenance Period Ranked Secondary Endpoint 6: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52
Time Frame: Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
Week 52
Maintenance Period Ranked Secondary Endpoint 7: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission (Per FMS) at Week 52
Time Frame: Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
Week 52
Maintenance Period Ranked Secondary Endpoint 8: Percentage of Week 8 Responders (Per FMS) With IBDQ Response (Increase of IBDQ ≥ 16 From Baseline) at Week 52
Time Frame: Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.
Week 52
Maintenance Period Ranked Secondary Endpoint 9: Percentage of Week 8 Non-Responders With Clinical Remission (Per FMS) at Week 52
Time Frame: Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 non-responders are defined as participants not meeting the criteria of response (defined as a decrease in FMS of ≥ 3 points and ≥ 30% from baseline, plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS ≤ 1) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
Week 52
Maintenance Period Ranked Secondary Endpoint 10: Percentage of Week 8 Non-Remitters With Clinical Remission (Per FMS) at Week 52
Time Frame: Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 non-remitters are defined as participants not meeting the criteria of clinical remission at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
Week 52
Maintenance Period Ranked Secondary Endpoint 11: Percentage of Week 8 Responders (Per FMS) With Endoscopic Subscore of 0 at Week 52
Time Frame: Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per Full Mayo score) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Endoscopic remission is defined as an endoscopy subscore of 0.
Week 52
Maintenance Period Ranked Secondary Endpoint 12: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Subscore of 0 at Week 52
Time Frame: Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopic remission is defined as an endoscopy subscore of 0.
Week 52
Maintenance Period Ranked Secondary Endpoint 13: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Bowel Symptom Domain at Week 52
Time Frame: Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Bowel Symptom domain score range is 10 (severe problem) to 70 (normal health). Response is defined as increase of Bowel Symptom domain score ≥ 6 from baseline.
Week 52
Maintenance Period Ranked Secondary Endpoint 14: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Fatigue Item at Week 52
Time Frame: Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Response in IBDQ fatigue item (range 1 [severe problem] to 7 [normal health]) is defined as increase of IBDQ fatigue item ≥ 1 from baseline.
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M14-033
  • 2013-001682-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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