A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease

NCT00445432 | Completed Phase 2 Results

• 1 other identifier: M06-837
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 29

Brief Summary

To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical remission in Japanese subjects with Crohn's disease.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment

  Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) \<150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is \>= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.

  Week 52 of double-blind treatment

Secondary Outcomes (8)

• Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment

  Week 52 of double-blind treatment

• Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment

  Week 52 of double-blind treatment

• Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment

  Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment

• Number of Participants Who Had Clinical Remission at Week 52 of Open-label Treatment

  Week 52 of open-label treatment

• Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment

  Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment

Other Outcomes (8)

• Number of Participants Who Had Clinical Remission at Week 148

  Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)

• Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148

  Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)

• Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148

  Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)

Study Arms (3)

DB Adalimumab 40 mg eow

EXPERIMENTAL

Subjects received double-blind (DB) 40 mg adalimumab subcutaneously (SC) every other week (eow) during the DB treatment period lasting 52 weeks.

Biological: adalimumab

Placebo eow

PLACEBO COMPARATOR

Subjects received placebo subcutaneously (SC) every other week (eow) during the double-blind treatment period lasting 52 weeks.

Other: Placebo

OL Adalimumab 40 mg eow

EXPERIMENTAL

Subjects received open-label (OL) 40 mg adalimumab subcutaneously (SC) every other week (eow) during the double-blind treatment period lasting 52 weeks.

Biological: adalimumab

Interventions

adalimumab BIOLOGICAL

Subcutaneous injection of 40 mg adalimumab (0.8 mL/injection) every other week (eow)

Also known as: Humira, D2E7

DB Adalimumab 40 mg eow; OL Adalimumab 40 mg eow

Placebo OTHER

Subcutaneous injection of placebo (0.8 mL/injection) every other week (eow)

Placebo eow

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who successfully enrolled in and completed the M04-729, (NCT00445939) study

You may not qualify if:

• Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study

Sponsors & Collaborators

• Abbott: lead
• Eisai Co., Ltd.: collaborator

Study Sites (29)

Site Ref # / Investigator 46965

Aichi, Japan

Location

Site Ref # / Investigator 46977

Aichi, Japan

Location

Site Ref # / Investigator 46978

Aichi, Japan

Location

Site Ref # / Investigator 46979

Aichi, Japan

Location

Site Ref # / Investigator 46922

Chiba, Japan

Location

Site Ref # / Investigator 46974

Chiba, Japan

Location

Site Ref # / Investigator 46970

Ehime, Japan

Location

Site Ref # / Investigator 46971

Fukuoka, Japan

Location

Site Ref # / Investigator 46985

Fukuoka, Japan

Location

Site Ref # / Investigator 46986

Fukuoka, Japan

Location

Site Ref # / Investigator 46987

Fukuoka, Japan

Location

Site Ref # / Investigator 46968

Hiroshima, Japan

Location

Site Ref # / Investigator 46973

Hokkaido, Japan

Location

Site Ref # / Investigator 6881

Hokkaido, Japan

Location

Site Ref # / Investigator 46982

Hyōgo, Japan

Location

Site Ref # / Investigator 46969

Kagawa, Japan

Location

Site Ref # / Investigator 46927

Kanagawa, Japan

Location

Site Ref # / Investigator 46984

Kochi, Japan

Location

Site Ref # / Investigator 46981

Kyoto, Japan

Location

Site Ref # / Investigator 46921

Miyagi, Japan

Location

Site Ref # / Investigator 46983

Okayama, Japan

Location

Site Ref # / Investigator 46966

Osaka, Japan

Location

Site Ref # / Investigator 46967

Osaka, Japan

Location

Site Ref # / Investigator 46980

Shiga, Japan

Location

Site Ref # / Investigator 46964

Shizuoka, Japan

Location

Site Ref # / Investigator 46923

Tokyo, Japan

Location

Site Ref # / Investigator 46924

Tokyo, Japan

Location

Site Ref # / Investigator 46975

Tokyo, Japan

Location

Site Ref # / Investigator 46976

Tokyo, Japan

Location

Related Publications (2)

• Watanabe M, Hibi T, Mostafa NM, Chao J, Arora V, Camez A, Petersson J, Thakkar R. Long-term safety and efficacy of adalimumab in Japanese patients with moderate to severe Crohn's disease. J Crohns Colitis. 2014 Nov;8(11):1407-16. doi: 10.1016/j.crohns.2014.04.012. Epub 2014 May 27.

  PMID: 24874893 DERIVED

• Watanabe M, Hibi T, Lomax KG, Paulson SK, Chao J, Alam MS, Camez A; Study Investigators. Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn's disease. J Crohns Colitis. 2012 Mar;6(2):160-73. doi: 10.1016/j.crohns.2011.07.013. Epub 2011 Aug 26.

  PMID: 22325170 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

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: Abbott

800-633-9110

Study Officials

• Kazuko Kobayashi

  Abbott

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 9, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: November 1, 2010
• Last Updated: February 2, 2012
• Results First Posted: June 9, 2010

Record last verified: 2012-02

Locations

JP (29)