A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease

NCT01243671 | Completed Phase 3 Results

• 1 other identifier: M11-509
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 12

Brief Summary

To investigate efficacy, safety and pharmacokinetics of adalimumab subcutaneous (sc) for Japanese subjects with intestinal Behçet's disease who are refractory to conventional therapies.

Conditions

Intestinal Behçet's Disease

Keywords

Behçet's, intestinal

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Marked Improvement at Week 24

  Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to \<2 cm, ≥2 cm to \<3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).

  24 weeks

Secondary Outcomes (9)

• Number of Participants With Marked Improvement at Week 52

  52 weeks

• Number of Participants With Complete Remission at Week 24 and Week 52

  24 weeks, 52 weeks

• Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52

  24 weeks, 52 weeks

• Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52

  24 weeks, 52 weeks

• Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52

  24 weeks, 52 weeks

Study Arms (1)

Adalimumab

EXPERIMENTAL

Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.

Biological: Adalimumab

Interventions

Adalimumab BIOLOGICAL

Also known as: ABT-D2E7, Humira

Adalimumab

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Intestinal Behçet's disease
• Patients with typical ulcer at ileocecal region
• Patients who have failed conventional treatment

You may not qualify if:

• Crohn's disease
• History of ileocecal resection
• History of tuberculosis (TB)
• Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Eisai Co., Ltd.: collaborator

Study Sites (12)

Site Reference ID/Investigator# 46738

Chikushino-shi, Japan

Location

Site Reference ID/Investigator# 46723

Kurume, Japan

Location

Site Reference ID/Investigator# 46728

Nagoya, Japan

Location

Site Reference ID/Investigator# 46725

Nishinomiya-shi, Japan

Location

Site Reference ID/Investigator# 46730

Osaka, Japan

Location

Site Reference ID/Investigator# 46722

Sagamihara-shi, Japan

Location

Site Reference ID/Investigator# 46726

Sakura, Japan

Location

Site Reference ID/Investigator# 59578

Sapporo, Japan

Location

Site Reference ID/Investigator# 46724

Takatsuki-shi, Japan

Location

Site Reference ID/Investigator# 46729

Tokyo, Japan

Location

Site Reference ID/Investigator# 46737

Tokyo, Japan

Location

Site Reference ID/Investigator# 46733

Yokohama, Japan

Location

Related Publications (2)

• Inoue N, Kobayashi K, Naganuma M, Hirai F, Ozawa M, Arikan D, Huang B, Robinson AM, Thakkar RB, Hibi T. Long-term safety and efficacy of adalimumab for intestinal Behcet's disease in the open label study following a phase 3 clinical trial. Intest Res. 2017 Jul;15(3):395-401. doi: 10.5217/ir.2017.15.3.395. Epub 2017 Jun 12.

  PMID: 28670237 DERIVED

• Tanida S, Inoue N, Kobayashi K, Naganuma M, Hirai F, Iizuka B, Watanabe K, Mitsuyama K, Inoue T, Ishigatsubo Y, Suzuki Y, Nagahori M, Motoya S, Nakamura S, Arora V, Robinson AM, Thakkar RB, Hibi T. Adalimumab for the treatment of Japanese patients with intestinal Behcet's disease. Clin Gastroenterol Hepatol. 2015 May;13(5):940-8.e3. doi: 10.1016/j.cgh.2014.08.042. Epub 2014 Sep 19.

  PMID: 25245624 DERIVED

Related Links

• Related info

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Morio Ozawa, MS

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 18, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2013
• Last Updated: July 25, 2014
• Results First Posted: May 15, 2013

Record last verified: 2014-06

Locations

JP (12)