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A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ulcerative Colitis

Intervention: adalimumab (Biological); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Morio Ozawa, MS, Study Director, Affiliation: AbbVie GK

Summary

The purpose of this study is to assess the efficacy and safety of adalimumab in Japanese subjects with moderately to severely active ulcerative colitis (UC).

Clinical Details

Official title: A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Percentage of Participants With Clinical Remission at 8 Weeks

Percentage of Participants With Clinical Remission at 52 Weeks

Secondary outcome:

Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks

Percentage of Participants With a Clinical Response

Percentage of Participants With Mucosal Healing

Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1)

Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1)

Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1)

Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders

Number of Participants With Adverse Events up to Week 8

Number of Participants With Adverse Events up to Week 52

Number of Participants With Adverse Events During the Adalimumab Treatment Period

Detailed description: Patients who meet all of the inclusion criteria and none of the exclusion criteria are randomized 1: 1:1 to receive subcutaneous injections of adalimumab at either 160/80 mg at Week 0/2 and 40 mg every other week (eow) starting at Week 4 to Week 50, 80/40 mg at Week 0/2 and 40 mg eow starting at Week 4 to Week 50, or placebo eow starting at Week 0 to Week 50 under the double-blind condition. At or after Week 8, participants who have inadequate response during the double-blind period can switch to the rescue arm, where participants from the placebo group initially receive adalimumab 160 mg and 80 mg 2 weeks later and those from the adalimumab group receive adalimumab 40 mg initially and 2 weeks later under double-blind conditions. All participants in the rescue arm then receive 40 mg adalimumab eow until Week 50. Participants who complete the 52-week double-blind period receive open-label adalimumab 40 mg eow starting at Week 52 and continuing until the end of the study. Participants who have an inadequate response or disease flare can dose escalate to 80 mg eow at or after Week 60. Participants who dose escalate to 80 mg eow and continue to have an inadequate response or disease flare are withdrawn from the study.

Eligibility

Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline.

- Active ulcerative colitis with a Mayo Score of 6-12 points at Baseline and endoscopy

subscore of 2-3 during the Screening Period, despite concurrent treatment with at least one of the following (oral corticosteroids or immunosuppressants or both as defined below):

- Stable oral corticosteroid dose (prednisolone dose of ≥ 20 mg/day or equivalent) for

at least 14 days prior to Baseline or stable oral corticosteroid dose (prednisolone of 5 to less than 20 mg/day) for at least 40 days prior to Baseline. And/or

- At least a consecutive 90-day course of azathioprine or 6-mercaptopurine (6-MP) prior

to Baseline, with a dose of azathioprine ≥ 50 mg/day or 6-MP ≥ 30 mg/day, or a dose that was the highest tolerated by the patient. Exclusion Criteria:

- History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch,

Koch pouch, or ileostomy for ulcerative colitis or was planning bowel surgery.

- Patients with disease limited to the rectum.

- Indeterminate colitis and/or Crohn's disease.

- Received any biological therapy (including infliximab) in the past.

- History of tuberculosis or malignancy.

- Pregnant women.

- Patients with positive C. difficile stool assay at Screening.

- Current diagnosis of fulminant colitis and/or toxic megacolon.

Locations and Contacts

Site Reference ID/Investigator# 47136, Asahikawa, Japan

Site Reference ID/Investigator# 47159, Chiba, Japan

Site Reference ID/Investigator# 47183, Chikushino, Japan

Site Reference ID/Investigator# 47135, Fukuoka-shi, Japan

Site Reference ID/Investigator# 47182, Fukuoka-shi, Japan

Site Reference ID/Investigator# 47124, Hamamatsu, Japan

Site Reference ID/Investigator# 47130, Hirakata-shi, Japan

Site Reference ID/Investigator# 47103, Hirosaki, Japan

Site Reference ID/Investigator# 47131, Hiroshima-shi, Japan

Site Reference ID/Investigator# 47178, Hiroshima, Japan

Site Reference ID/Investigator# 47179, Hiroshima, Japan

Site Reference ID/Investigator# 47176, Izumo, Japan

Site Reference ID/Investigator# 47226, Kagoshima, Japan

Site Reference ID/Investigator# 47123, Kanazawa-shi, Japan

Site Reference ID/Investigator# 47160, Kashiwa, Japan

Site Reference ID/Investigator# 47108, Kawagoe, Japan

Site Reference ID/Investigator# 47107, Koshigaya, Japan

Site Reference ID/Investigator# 47181, Kurume, Japan

Site Reference ID/Investigator# 47222, Kurume, Japan

Site Reference ID/Investigator# 47223, Kurume, Japan

Site Reference ID/Investigator# 47170, Kyoto-shi, Japan

Site Reference ID/Investigator# 47171, Kyoto-shi, Japan

Site Reference ID/Investigator# 47127, Kyoto, Japan

Site Reference ID/Investigator# 47172, Kyoto, Japan

Site Reference ID/Investigator# 47134, Matsuyama-shi, Japan

Site Reference ID/Investigator# 47225, Miyazaki, Japan

Site Reference ID/Investigator# 47138, Morioka-shi, Japan

Site Reference ID/Investigator# 47168, Nagakute-shi, Japan

Site Reference ID/Investigator# 47125, Nagoya-shi, Japan

Site Reference ID/Investigator# 47126, Nagoya-shi, Japan

Site Reference ID/Investigator# 47166, Nagoya-shi, Japan

Site Reference ID/Investigator# 47122, Niigata-shi, Japan

Site Reference ID/Investigator# 47227, Nishihara, Japan

Site Reference ID/Investigator# 47174, Nishinomiya-shi, Japan

Site Reference ID/Investigator# 47224, Oita, Japan

Site Reference ID/Investigator# 47177, Okayama-shi, Japan

Site Reference ID/Investigator# 47228, Okinawa, Japan

Site Reference ID/Investigator# 47128, Osaka-shi, Japan

Site Reference ID/Investigator# 47129, Osaka, Japan

Site Reference ID/Investigator# 47169, Otsu-shi, Japan

Site Reference ID/Investigator# 47118, Sagamihara-shi, Japan

Site Reference ID/Investigator# 47158, Saitama-shi, Japan

Site Reference ID/Investigator# 47109, Sakura, Japan

Site Reference ID/Investigator# 15853, Sapporo-shi, Japan

Site Reference ID/Investigator# 47137, Sapporo, Japan

Site Reference ID/Investigator# 47104, Sendai-shi, Japan

Site Reference ID/Investigator# 47147, Sendai-shi, Japan

Site Reference ID/Investigator# 47180, Susaki-shi, Japan

Site Reference ID/Investigator# 47133, Takamatsu, Japan

Site Reference ID/Investigator# 47173, Takatsuki-shi, Japan

Site Reference ID/Investigator# 47106, Tokorozawa-shi, Japan

Site Reference ID/Investigator# 47132, Tokushima, Japan

Site Reference ID/Investigator# 47110, Tokyo, Japan

Site Reference ID/Investigator# 47111, Tokyo, Japan

Site Reference ID/Investigator# 47112, Tokyo, Japan

Site Reference ID/Investigator# 47116, Tokyo, Japan

Site Reference ID/Investigator# 47117, Tokyo, Japan

Site Reference ID/Investigator# 47161, Tokyo, Japan

Site Reference ID/Investigator# 47164, Tokyo, Japan

Site Reference ID/Investigator# 47165, Toyama, Japan

Site Reference ID/Investigator# 47167, Toyoake, Japan

Site Reference ID/Investigator# 47105, Yamagata-shi, Japan

Site Reference ID/Investigator# 47175, Yamatotakada, Japan

Site Reference ID/Investigator# 47121, Yokohama-shi, Japan

Site Reference ID/Investigator# 47120, Yokohama, Japan

Additional Information

Starting date: February 2009
Last updated: September 3, 2014

Page last updated: August 23, 2015

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