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Summary

for people ages 4–17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).

Official Title

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

Keywords

Ulcerative Colitis adalimumab Colitis Ulcer Colitis, Ulcerative

Eligibility

You can join if…

Open to people ages 4–17

  • Diagnosis of Ulcerative Colitis (UC) for at least 12 weeks prior to screening,confirmed by endoscopy with biopsy.
  • Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of 2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both.

You CAN'T join if...

  • 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).

Locations

  • Univ California, San Francisco accepting new patients
    San Francisco, California, 94143, United States
  • MultiCare Institute for Resear accepting new patients
    Tacoma, Washington, 98405, United States
  • Minnesota Gastroenterology P.A accepting new patients
    Saint Paul, Minnesota, 55114, United States
  • Mayo Clinic accepting new patients
    Rochester, Minnesota, 55905, United States
  • Loyola University Medical Ctr not yet accepting patients
    Maywood, Illinois, 60153, United States
  • University of Chicago not yet accepting patients
    Chicago, Illinois, 60637-1443, United States
  • Indiana University accepting new patients
    Indianapolis, Indiana, 46202, United States
  • Children's Ctr Digestive, US accepting new patients
    Atlanta, Georgia, 30342, United States
  • Emory University Hospital accepting new patients
    Atlanta, Georgia, 30322, United States
  • Western University not yet accepting patients
    London, Ontario, N6A 5A5, Canada
  • Univ Rochester Med Ctr accepting new patients
    Rochester, New York, 14642, United States
  • Arnold Palmer Hosp Children accepting new patients
    Orlando, Florida, 32806, United States
  • Goryeb Chidlren's Hospital not yet accepting patients
    Morristown, New Jersey, 07960, United States
  • North Shore University Hospital accepting new patients
    New Hyde Park, New York, 11040, United States
  • Boston Childrens Hospital not yet accepting patients
    Boston, Massachusetts, 02115, United States
  • Massachusetts General Hospital not yet accepting patients
    Boston, Massachusetts, 02114, United States
  • Hosp Univ Enfants Reine Fabiol not yet accepting patients
    Brussels, 1020, Belgium
  • UZ Brussel accepting new patients
    Brussels, 1050, Belgium
  • Cliniques Univ. Saint Luc accepting new patients
    Brussels, 1200, Belgium
  • Hospital Univ Vall d'Hebron accepting new patients
    Barcelona, 08035, Spain
  • Hosp Infantil Univ Nino Jesus accepting new patients
    Madrid, 28009, Spain
  • Uni Szpital Dzieciecy w Krakow accepting new patients
    Krakow, 30-633, Poland
  • Polish Mothers Memorial Hosp accepting new patients
    Lodz, 93-338, Poland
  • Gabinet Lekarski Bartosz Korcz accepting new patients
    Rzeszow, 35-210, Poland
  • Centrum Zdrowia Matki Dziecka accepting new patients
    Warsaw, 00-632, Poland
  • Samodzielny Publiczny Szpital accepting new patients
    Wroclaw, 50-088, Poland
  • Palacky University not yet accepting patients
    Olomouc, 779 00, Czechia
  • Univ Hosp, Plzen, CZ accepting new patients
    Plzen, 305 99, Czechia
  • LKH Salzburg and Paracelsus accepting new patients
    Salzburg, 5020, Austria
  • Medical University of Vienna not yet accepting patients
    Vienna, 1090, Austria
  • FN s poliklinikou F.D. Rooseve not yet accepting patients
    Banska Bystrica, 97517, Slovakia
  • Univerzitna Nemocnica Bratisla accepting new patients
    Bratislava, 821 01, Slovakia
  • Univerzitna nemocnica Martin accepting new patients
    Martin, 036 01, Slovakia
  • Petz Aladar Megyei Oktato Korh not yet accepting patients
    Gyor, 9023, Hungary
  • Balassa Janos County Hospital not yet accepting patients
    Szekszard, 7100, Hungary
  • Canterbury District Health Boa accepting new patients
    Christchurch, 8011, New Zealand
  • Soroka Medical Ctr not yet accepting patients
    Be'er Sheva, 84101, Israel
  • Assaf Harofeh Medical Center not yet accepting patients
    Be'er Ya'akov, 70300, Israel
  • Rambam Health Care Campus accepting new patients
    Haifa, 3109601, Israel
  • The Edith Wolfson Medical Cent not yet accepting patients
    Holon, 58100, Israel
  • Shaare Zedek Medical Center not yet accepting patients
    Jerusalem, 91031, Israel
  • Schneider Childrens Med Ctr not yet accepting patients
    Petah Tikva, 4920235, Israel
  • Sheba Medical Center accepting new patients
    Ramat Gan, 5262100, Israel
  • Kaplan Medical Center not yet accepting patients
    Rehovot, 76100, Israel

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
http://rxabbvie.com/
ID
NCT02065557
Phase
Phase 3
Lead Scientist
Melvin Heyman
Study Type
Interventional
Last Updated
January 12, 2018
I’m interested in this study!