Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease

Last updated: December 30, 2018
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Inflammatory Bowel Disease

Ulcerative Colitis

Colic

Treatment

N/A

Clinical Study ID

NCT02499783
M14-233
  • Ages 18-70
  • All Genders

Study Summary

This study will evaluate the efficacy and safety of adalimumab induction and maintenance treatment in subjects with moderately to severely active Crohn's disease in China.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects of Chinese descent with full Chinese parentage.

  • Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week 0.

  • Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than orequal to 450 despite treatment with oral corticosteroids and/or immunosuppressants.

  • Subject has a negative Tuberculosis (TB) Screening Assessment.

  • Subject has elevated high sensitivity C-reactive protein (hs-CRP) during the ScreeningPeriod.

Exclusion

Exclusion Criteria:

  • Subject with ulcerative colitis or indeterminate colitis.

  • Subject who has had a surgical bowel resection within the past 6 months or who isplanning any resection at any time point in the future.

  • Subject with an ostomy or ileoanal pouch.

  • Subject who has short bowel syndrome.

  • Subject with symptomatic known obstructive strictures.

  • Subject with an internal or external fistula (with the exception of an anal fistulawithout abscess).

  • Active, or chronic or recurring infections, or active tuberculosis.

Study Design

Total Participants: 205
Study Start date:
August 17, 2015
Estimated Completion Date:
December 15, 2017

Connect with a study center

  • Nanfang Hosp Southern Med Univ

    Guangzhou, Anhui 510000
    China

    Site Not Available

  • Sir Run Run Shaw Hospital

    Hangzhou, Anhui 310016
    China

    Site Not Available

  • Xinhua Hosp Shanghai Jiaotong

    Shanghai, Anhui 200092
    China

    Site Not Available

  • Zhongshan Hospital Xiamen Univ

    Xiamen, Anhui 361004
    China

    Site Not Available

  • Xijing Hospital

    Xian, Shaanxi 710032
    China

    Site Not Available

  • The Army General Hospital, PLA

    Beijing, 100700
    China

    Site Not Available

  • 2nd Xiangya Hosp South Univ

    Changsha, 410011
    China

    Site Not Available

  • West China Univ Hospital

    Chengdu, 610041
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University /ID# 138221

    Guangdong, 510080
    China

    Site Not Available

  • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 138222

    Guangzhou, Guangdong, 510655
    China

    Site Not Available

  • Site Reference ID/Investigator# 138229

    Hangzhou,, 310016
    China

    Site Not Available

  • 1st Aff Hosp Nanchang Univ

    Nanchang, 330006
    China

    Site Not Available

  • Tongji Hosp Tongji Med College

    Wuhan, 430030
    China

    Site Not Available

  • The 1st Affiliated Hospital of 4th Military Medical Univ /ID# 138225

    Xi'an, 7100032
    China

    Site Not Available

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