Safety and Efficacy of Adalimumab Versus Ustekinumab for one Year

Last Updated   January 26, 2019 - 00:00

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 3
    The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Sites
    197 sites
  • Status
    Recruiting

SUMMARY

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn’s disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

CONDITIONS

  • Crohn Disease

ELIGIBILITY

Inclusion Criteria:

  • • Has Crohn’s Disease (CD) or fistulizing CD of at least 3 months’ duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy
  • • Has moderately-to-severely active CD with a baseline Crohn’s disease activity index (CDAI) score of greater than or equal to (>=) 220 and less than or equal to (<=) 450
  • • Has one or more ulceration on screening ileocolonoscopy which will result in an Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score of at least 3
  • • Has failed or was intolerant to conventional therapy (corticosteroids, azathioprine [AZA], 6-mercaptopurine [6-MP] and/or methotrexate [MTX]) at adequate doses or is corticosteroid dependent
  • • Has not previously received an approved biologic for Crohn's Disease (i.e., infliximab, adalimumab, certolizumab pegol, ustekinumab, natalizumab, vedolizumab or approved biosimilars of these agents)
  • • Participants on oral corticosteroids (e.g., prednisone, budesonide) at a prednisone-equivalent dose of <=40 or milligram/day (mg/day) or <=9 mg/day of budesonide are budesonide <=9 mg/day are permitted if doses are stable for 3 weeks prior to baseline
  • • Participants on AZA, 6-MP, or MTX at screening (or recently prior), must discontinue these medications at least 3 weeks prior to baseline

Exclusion Criteria:

  • • Has complications of CD that are likely to require surgery or would confound the ability to assess the effect of ustekinumab or adalimumab treatment using the CDAI, such as: Short-gut syndrome and severe or symptomatic strictures or stenosis
  • • Currently has, or is suspected to have, an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior for intra-abdominal abscesses, if there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses present
  • • Has had any kind of bowel resection within 6 months prior to baseline or other intra-abdominal surgery or a hospital admission for bowel obstruction within 3 months prior to baseline
  • • Has a stool culture or other examination positive for an enteric pathogen, including Clostridium difficile toxin, in the last 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen
  • • Has received a Bacillus Calmette–Guerin (BCG) vaccination within 12 months or any other live bacterial or live viral vaccination within 2 weeks of baseline
  • • Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (eg, recurrent pyelonephritis or chronic nonremitting cystitis), or infected skin wounds or ulcers

DETAILS

This study compares the safety and efficacy of ustekinumab versus adalimumab. It will consist of screening (within 1- 5 weeks prior to Week 0), treatment phase (Weeks 0 to 52), and follow-up phase (up to Week 76). The primary hypothesis is that ustekinumab is superior to adalimumab as measured by clinical remission after one year of treatment. Study assessments will include Crohn’s disease activity index (CDAI), video ileocolonoscopy; CD-related healthcare utilization; patient-reported outcomes (PROs); laboratory evaluations; biomarkers; review of concomitant medications and adverse events (AEs); and evaluation of serum concentrations of study agent as well as development of antibodies to study agent. All participants will randomly be assigned to receive either ustekinumab or adalimumab. No participants will be treated with placebo only.

LOCATIONS

Locations in:
United States, Germany, Belgium, Netherlands, Poland, Italy, Brazil, Canada, Russia, Serbia, Spain, Australia, United Kingdom, Hungary, France, Czech Republic, Bulgaria, South Korea
City or Province (197) Country (18) Status
Atlanta, GA ATLANTA GASTROENTEROLOGY ASSOCIATES United States
Not yet recruiting
Great Neck, NY NYU Langone Long Island Clinical Research Associates United States
Not yet recruiting
Atlanta, GA Emory University United States
Not yet recruiting
Seattle, WA University of Washington United States
Not yet recruiting
Mentor, OH Great Lakes Gastroenterology Research, LLC United States
Recruiting
Clearwater, FL Gastro Florida United States
Recruiting
Chesterfield, MI Clinical Research Institute of Michigan, LLC United States
Recruiting
Wilmington, NC Wilmington Gastroenterology Associates United States
Recruiting
Chicago, IL Northwestern University United States
Not yet recruiting
Suffolk, VA Virginia Gastroenterology Institute United States
Not yet recruiting
Hershey, PA Penn State Milton S. Hershey Medical Center United States
Not yet recruiting
La Jolla, CA UC San Diego United States
Not yet recruiting
Freiburg, BW Universitatsklinikum Freiburg Germany
Not yet recruiting
Hamburg, HH Asklepios Westklinikum Germany
Not yet recruiting
Muenster MVZ Portal10 Germany
Not yet recruiting
München Klinik für Innere Medizin II Germany
Not yet recruiting
Berlin, BE DRK Kliniken Westend Germany
Not yet recruiting
Brussel, BRU Cliniques Universitaires Saint-Luc Belgium
Not yet recruiting
Amsterdam VUMC Amsterdam Netherlands
Not yet recruiting
Leiden Leiden University Medical Center Netherlands
Not yet recruiting
Port Orange, FL Advanced Medical Research Center United States
Recruiting
Bridgeport, CT Gastro Associates of Fairfield County PC United States
Recruiting
Chapel Hill, NC University of North Carolina at Chapel Hill United States
Recruiting
Gdańsk Synexus Polska Sp. z o.o. Poland
Not yet recruiting
Rotterdam Ikazia Ziekenhuis Netherlands
Not yet recruiting
Raleigh, NC Duke University Hospital Medical Center United States
Not yet recruiting
New York, NY Mount Sinai School of Medicine United States
Not yet recruiting
Richmond, VA McGuire VAMC United States
Not yet recruiting
Torino AO Ordine Mauriziano Italy
Not yet recruiting
Milano ASST Fatebenefratelli Sacco Italy
Not yet recruiting
Palermo Ospedale Villa Sofia-Cervello Italy
Not yet recruiting
Bologna Policlinico Sant'Orsola Malpighi Italy
Not yet recruiting
Roma Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata' Italy
Not yet recruiting
Messina AOU Policlinico G.Martino Italy
Not yet recruiting
Rho Azienda Ospedaliera G.Salvini Ospedale di Rho Italy
Not yet recruiting
Suwanee, GA Atlanta Gastroenterology Specialists, PC United States
Recruiting
Naples, FL Gastroenterology Group Of Naples United States
Recruiting
Southlake, TX Texas Digestive Disease Consultants United States
Recruiting
Pratt, KS Health Science Research Center United States
Recruiting
Norfolk, VA Digestive And Liver Disease Specialists United States
Recruiting
Ypsilanti, MI Huron Gastroenterology Associates Center for Digestive Care United States
Recruiting
Shreveport, LA Louisiana Research Center, LLC United States
Recruiting
San Diego, CA Precision Research Institute United States
Recruiting
Houma, LA CroNOLA, LLC United States
Recruiting
Crestview Hills, KY Tri-State Gastroenterology Assoc United States
Recruiting
Chesapeake, VA Gastroenterology Associates of Tidewater United States
Recruiting
Rio De Janeiro, RJ Hospital Copa D’Or Brazil
Not yet recruiting
São Paulo, SP Hospital Das Clinicas Da Faculdade De Medicina Da USP Brazil
Not yet recruiting
Rio De Janeiro, RJ UFRJ-Hospital Universitário Clementino Fraga Filho Brazil
Not yet recruiting
Heidelberg, BW Uniklinikum Heidelberg Germany
Not yet recruiting
Arnhem, GE Rijnstate Ziekenhuis Netherlands
Not yet recruiting
Columbus, OH Ohio State University Hospital United States
Not yet recruiting
Greenfield Park, QC CISSS de la Monteregie Centre Canada
Not yet recruiting
Moscow GU 'Moscow Regional Research Clinical Institute n.a. M.F.Vla Russia
Not yet recruiting
Novosibirsk State Scientific-research Institute of Psysiology and Basic Medicine Russia
Not yet recruiting
Saint Petersburg Clinical Hospital #122 n.a. after L.G. Sokolov Russia
Not yet recruiting
St. Louis, MO Saint Louis University Hospital United States
Not yet recruiting
Washington, DC MedStar Georgetown University Hospital United States
Not yet recruiting
Cincinnati, OH TriHealth Digestive Institute United States
Not yet recruiting
Maitland, FL Center for Advanced Gastroenterology - Main Office United States
Recruiting
Zemun Clinical Hospital Center Bezanijska Kosa Serbia
Not yet recruiting
Kragujevac Clinical Center Kragujevac Serbia
Not yet recruiting
Belgrade Clinical Hospital Center Zemun Serbia
Not yet recruiting
Vojvodina Clinical Center of Vojvodina Serbia
Not yet recruiting
Belgrade Clinical Hospital Center Zvezdara Serbia
Not yet recruiting
Nis Clinical Center Nis Serbia
Not yet recruiting
Pittsburgh, PA Allegheny-Singer Research Institute United States
Not yet recruiting
Greenville, SC Greenville Health System United States
Not yet recruiting
Colorado Springs, CO Peak Gastroenterology Associates United States
Recruiting
Krakow Malopolskie Centrum Medyczne Poland
Recruiting
Barcelona, BA HOSP. DE LA SANTA CREU I SANT PAU Spain
Recruiting
Sabadell, BA CORPORACIO SANITARI PARC TAULI Spain
Recruiting
San Antonio, TX Gastroenterology Research of America, LLC United States
Recruiting
Idaho Falls, ID Grand Teton Research Group, PLLC United States
Recruiting
Burnt Hills, NY Saratoga Schenectady Gastroenterology Associates United States
Recruiting
Woodville South, SA The Queen Elizabeth Hospital Australia
Not yet recruiting
Subiaco, WA St John of God Subiaco Hospital Australia
Not yet recruiting
Melbourne, VIC Alfred Hospital Australia
Not yet recruiting
Clayton, VIC Monash Health, Monash Medical Centre Australia
Not yet recruiting
New York, NY Weill Cornell Medical College United States
Not yet recruiting
Largo, FL Florida Center For Gastroenterology United States
Not yet recruiting
Mont-Royal, QC CMIIM, Centre médical L'Enjeu Canada
Recruiting
Warsaw Centralny Szpital Kliniczny MSWiA w Warszawie Poland
Recruiting
Bialystok Gastromed S.C. Maciej Karlisz, Jacek Romatowski Poland
Recruiting
Salamanca, SL HOSP. CLINICO UNIV. DE SALAMANCA Spain
Recruiting
Zaragoza, ZR HOSP. UNIV. MIGUEL SERVET Spain
Recruiting
Santander, CT HOSP. UNIV. MARQUES DE VALDECILLA Spain
Recruiting
Oviedo, AS HOSP. UNIV. CENTRAL DE ASTURIAS Spain
Recruiting
London St George's Hospital United Kingdom
Recruiting
Taunton, SOM Musgrove Park Hospital United Kingdom
Recruiting
Santo Andre, SP FACULDADE DE MEDICINA DO ABC Brazil
Recruiting
Mobile, AL Alabama Medical Group United States
Recruiting
Dayton, OH Dayton Gastroenterology, Inc United States
Recruiting
Lynchburg, VA Gastroenterology Associates of Central Virginia United States
Not yet recruiting
Danbury, CT Western Connecticut Health Network/Danbury Hospital United States
Not yet recruiting
Chicago, IL Rush University Medical Center United States
Not yet recruiting
North Chesterfield, VA Richmond Gastroenterology Associates United States
Not yet recruiting
London, ON London Health Sciences Centre Canada
Recruiting
Hamilton, ON McMaster University Canada
Recruiting
Békéscsaba Réthy Pál Kórház - Rendelőintézet Hungary
Recruiting
Debrecen Debreceni Egyetem Klinikai Kozpont Hungary
Recruiting
Warszawa Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz Poland
Recruiting
Lublin Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Oddział Gastroenterologii Poland
Recruiting
Budapest Magyar Honvedseg Egeszsegugyi Kozpont Hungary
Recruiting
Sevilla HOSP. VIRGEN MACARENA Spain
Recruiting
Paris Hopital Saint-Louis France
Recruiting
Saint Priest En Jarez CHU Saint-etienne France
Recruiting
Kingston Upon Thames Kingston Hospital United Kingdom
Recruiting
Bury Pennine Acute Hospitals-Fairfield General Hospital United Kingdom
Recruiting
Bath Royal United Hospital United Kingdom
Recruiting
Tacoma, WA Washington Gastroenterology, PLLC United States
Recruiting
Horovice Nemocnice Horovice, a.s. Czech Republic
Recruiting
Tyler, TX Tyler Research Institute, LLC United States
Not yet recruiting
Bristol, CT Connecticut Clinical Research, LLC United States
Not yet recruiting
Washington, DC Medstar Washington Hospital Center United States
Not yet recruiting
Hradec Kralove Hepato-gastroenterologie HK, s.r.o. Czech Republic
Recruiting
New York, NY Columbia University Medical Center United States
Recruiting
Rochester, MN Mayo Clinic United States
Recruiting
Calgary, AB University of Calgary Canada
Recruiting
Nashville, TN Vanderbilt University Medical Center United States
Recruiting
Miskolc Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz Hungary
Recruiting
Budapest Semmelweis Egyetem Hungary
Recruiting
Szombathely Markusovszky Egyetemi Oktatokorhaz Hungary
Recruiting
Sopot, PM Endoskopia Sp. z o.o. z siedzibą w Sopocie Poland
Recruiting
Varna, 03 Diagnostic Consulting Center Mladost - M Varna Bulgaria
Recruiting
Pleven UMHAT 'Dr. Georgi Stranski', EAD Bulgaria
Recruiting
Rousse, 18 MHAT Rousse Bulgaria
Recruiting
Girona, GI HOSP. UNIV. DR. JOSEP TRUETA Spain
Recruiting
Valladolid, VD HOSP. UNIV. RIO HORTEGA Spain
Recruiting
Tournai, WHT CHwapi Belgium
Recruiting
Leuven UZ Leuven Belgium
Recruiting
Amiens CHU Amiens France
Recruiting
Nantes HOTEL DIEU France
Recruiting
Garland, TX DHAT Research Institute United States
Recruiting
London Guy's and St Thomas' Hospital United Kingdom
Recruiting
Porto Alegre HOSPITAL DE CLÍNICAS DE PORTO ALEGRE Brazil
Recruiting
Juiz De Fora, MG Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida Brazil
Recruiting
St.-Petersburg Northen-Western State Medical University n.a. I.I. Mechnikov Russia
Withdrawn
Saint Petersburg City Clinical Hospital #31 Russia
Recruiting
Rostov-On-Don Rostov State Medical University Russia
Recruiting
Irkutsk Irkutsk State Medical Academy of Postgraduate Education Russia
Recruiting
Poughkeepsie, NY Premier Medical Group Of The Hudson Valley, Pc United States
Recruiting
Daegu Yeungnam University Medical Center South Korea
Recruiting
Suwon-Si, 41 The Catholic University of Korea St. Vincent's Hospital South Korea
Recruiting
Fargo, ND Fargo Gastroenterology Clinic, PC United States
Recruiting
Praha 7 ISCARE I.V.F. a.s. Czech Republic
Recruiting
Usti Nad Labem Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Czech Republic
Withdrawn
Houston, TX Baylor College of Medicine United States
Not yet recruiting
Dallas, TX UT Southwestern - Parkland Hospital United States
Not yet recruiting
Praha 10 Fakultni nemocnice Kralovske Vinohrady Czech Republic
Recruiting
Belo Horizonte - Mg HOSPITAL DAS CLINICAS DA UFMG Brazil
Not yet recruiting
Louisville, KY University of Louisville United States
Recruiting
Hazard, KY Gastroenterology Associates Of Hazard United States
Recruiting
Oklahoma, OK Digestive Disease Specialists Inc United States
Recruiting
Edmonton, AB University of Alberta - Department of Medicine Canada
Withdrawn
Wroclaw Melita Medical Poland
Recruiting
Sofia 2-nd MHAT Bulgaria
Recruiting
Lodz Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego Poland
Recruiting
Barcelona, BA HOSP. DEL MAR Spain
Recruiting
Houston, TX University of Texas at Houston Medical School United States
Recruiting
Fairfax, VA Verity Research, Inc United States
Recruiting
Groningen, GR UMCG Netherlands
Recruiting
Montpellier CHRU Montpellier - Hopital Saint-Eloi France
Recruiting
Nijmegen, GE Radboudumc Netherlands
Recruiting
Rotterdam Sint Franciscus Gasthuis Netherlands
Recruiting
Tampa, FL Apex Clinical Research United States
Recruiting
Chevy Chase, MD Chevy Chase Clinical Research United States
Recruiting
Toulouse Clinique Ambroise Paré France
Recruiting
Southampton Southampton University Hospitals NHS Trust United Kingdom
Recruiting
Ribeirão Preto Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo Brazil
Recruiting
Goiania Clinica De Gastroenterologia Brazil
Recruiting
Saint Petersburg Union clinic Russia
Not yet recruiting
Saint Petersburg Elizavetinskaya hospital Russia
Not yet recruiting
Ufa GBUZ Respublican Clinical Hospital n.a. GG Kuvatova Russia
Not yet recruiting
Ufa City Clinical Hospital # 21 Russia
Not yet recruiting
Seoul Severance Hospital, Yonsei University Health System South Korea
Recruiting
Seoul Seoul National University Hospital South Korea
Recruiting
Seongnam-Si, 41 Seoul National University Bundang Hospital South Korea
Recruiting
Seoul Samsung Medical Center South Korea
Recruiting
Beachwood, OH Great Lakes Medical Research, LLC United States
Recruiting
Brno Fakultní nemocnice u sv. Anny v Brn Czech Republic
Recruiting
St. Louis, MO Washington University United States
Not yet recruiting
Rochester, NY University of Rochester Medical Center United States
Recruiting
Cleveland, OH University Hospitals Case Medical Center United States
Recruiting
Veszprém Csolnoky Ferenc Korhaz Hungary
Withdrawn
Gent UZ Gent Belgium
Recruiting
Weston, FL Cleveland Clinic Florida United States
Recruiting
Houston, TX Baylor College of Medicine United States
Not yet recruiting
Rozzano Istituto Clinico Humanitas Italy
Recruiting
Padova Azienda Ospedaliera di Padova Italy
Recruiting
Roma Fondazione Policlinico Gemelli Università Cattolica Italy
Recruiting
Roma Azienda Complesso Ospedaliero San Filippo Neri Italy
Recruiting
Bellevue, WA Washington Gastroenterology, PLLC United States
Recruiting
Ekaterinburg OOO MO New Hospital Russia
Recruiting
South Brisbane, QLD Mater Hospital Brisbane Australia
Recruiting
Seoul Asan Medical Center South Korea
Recruiting
Gainesville, FL Florida Research Network, LLC United States
Not yet recruiting
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