NCT00445939

Brief Summary

The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 23, 2009

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

10 months

First QC Date

March 7, 2007

Results QC Date

December 23, 2008

Last Update Submit

June 20, 2011

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4

    CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI \< 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4.

    4 Weeks

Secondary Outcomes (4)

  • Clinical Remission (CDAI < 150) at Week 2

    Week 2

  • Clinical Response (CR-70 and CR-100) in Period A

    Weeks 2 and Week 4

  • Clinical Response (CR-70 and CR-100) in Period B

    Week 6 and Week 8

  • Clinical Remission (CDAI <150) at Week 6 and Week 8

    Week 6 and Week 8

Study Arms (3)

Adalimumab 160 mg/80 mg

EXPERIMENTAL
Biological: adalimumab

Adalimumab 80 mg/40 mg

EXPERIMENTAL
Biological: adalimumab

Placebo

PLACEBO COMPARATOR
Biological: placebo

Interventions

adalimumabBIOLOGICAL

160 mg at Week 0, 80 mg at Week 2

Also known as: ABT-D2E7, Humira
Adalimumab 160 mg/80 mg
placeboBIOLOGICAL

Placebo at Week 0 and Week 2

Placebo

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Crohn's Disease Activity Index (CDAI) score of \>= 220 and \<= 450
  • If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy

You may not qualify if:

  • Ulcerative colitis or indeterminate colitis
  • History of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (TB), or Human immunodeficiency virus (HIV)
  • Body weight is below 30 kg
  • Surgical bowel resections within the past 6 months
  • Females who are pregnant or breast-feeding or considering becoming pregnant during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Aichi, Japan

Location

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Ehime, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Hiroshima, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Hyōgo, Japan

Location

Unknown Facility

Kagawa, Japan

Location

Unknown Facility

Kanagawa, Japan

Location

Unknown Facility

Kochi, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Miyagi, Japan

Location

Unknown Facility

Okayama, Japan

Location

Unknown Facility

Okinawa, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Shiga, Japan

Location

Unknown Facility

Shizuoka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

  • 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: 22325170DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Limitations and Caveats

Small population, therefore no statistical tests were performed

Results Point of Contact

Title
Global Medical Services
Organization
Abbott
800-633-9110

Study Officials

  • Morio Ozawa

    Abbott Japan Co.,Ltd

    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

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 9, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2007

Last Updated

June 27, 2011

Results First Posted

March 23, 2009

Record last verified: 2011-06

Locations

JP(18)