A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

A Multicenter Open-label Study of the Human Anti-Tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics After Dose Escalation in Japanese Subjects With Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958827
• Other study ID #: M13-687
• Status: Completed
• Phase: Phase 3
• First received: October 4, 2013
• Last updated: October 8, 2015
• Start date: September 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy, safety and pharmacokinetics after dose escalation in Japanese subjects with Crohn's Disease.

Description:

Subjects who are confirmed to meet all of the inclusion criteria and none of the exclusion criteria during screening period (=<21 days) will be given subcutaneous injections of open-label adalimumab 80 mg eow from Week 0 to Week 50. If a subject has an inadequate response at or after Week 8, the subject may be withdrawn from the study. Self-injection of study drug is permitted for the subjects who are willing to perform self-injection, if the investigator decided as appropriate. Disease activity will be evaluated by Crohn's disease activity index (CDAI) at Screening, Week 0 and every 4 weeks until Week 52. Follow-up will be performed at 70 days after the last dose of study drug by visit or telephone etc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 99 Years

Eligibility

Inclusion Criteria:

• Subject >=15 years of age at the time of informed consent.

• Subject with Crohn's disease who received induction treatment of commercially available Humira® (160 mg initially and 80 mg at 2 weeks after initial dose), achieved response after initial dose, and then lost response during maintenance treatment with Humira®.

• Subject with elevated CRP at Screening.

• If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after the last dose of study drug.

• Subject has a negative Tuberculosis (TB) Screening Assessment. If the subject has evidence of a latent TB infection; the subject must initiate and complete a minimum of 21 days of an ongoing TB prophylaxis (in such case, screening period can be prolonged until 21 days past after initiation of prophylaxis and study drug is administered) or have documented completion of a full course of TB prophylaxis, prior to Week 0.

Exclusion Criteria:

• Subject with suspicion of colitis other than Crohn's disease.

• Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).

• Subject with abscess or suspicion of abscess, or subject with infection(s).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Adalimumab
Subjects will be given subcutaneous injections of open-label adalimumab 80 mg eow from Week 0 to Week 50.

Locations

Country	Name	City	State
Japan	Site Reference ID/Investigator# 105698	Chikushino-shi
Japan	Site Reference ID/Investigator# 105700	Fukuoka-shi
Japan	Site Reference ID/Investigator# 105699	Hamamatsu-shi
Japan	Site Reference ID/Investigator# 105717	Hamamatsu-shi
Japan	Site Reference ID/Investigator# 107058	Hiroshima-shi
Japan	Site Reference ID/Investigator# 127299	Nishinomiya-shi
Japan	Site Reference ID/Investigator# 105718	Oita-shi
Japan	Site Reference ID/Investigator# 105697	Osaka-shi
Japan	Site Reference ID/Investigator# 118375	Otsu-shi
Japan	Site Reference ID/Investigator# 105696	Sakura-shi
Japan	Site Reference ID/Investigator# 105695	Sapporo-shi
Japan	Site Reference ID/Investigator# 105715	Suita-shi
Japan	Site Reference ID/Investigator# 107635	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adalimumab serum concentrations	Serum concentrations of adalimumab will be determined using a validated ligand binding assay (LBA) method under the supervision of the Bioanalysis Department of AbbVie.	Up to Week 52	No
Other	Presence of anti-adalimumab antibody (AAA)	AAA will be determined using a validated ligand binding assay (LBA) method under the supervision of the Bioanalysis Department of AbbVie.	up to Week 52	No
Primary	Proportion of the subjects who achieved Clinical Response	Clinical response will be determined by the Crohn's Disease Activity Index (CDAI) which is a research tool used to quantify the symptoms of patients with Crohn's disease.	Week 8	No
Secondary	Proportion of the subjects who achieved clinical remission	Clinical remission is defined as CDAI < 150.	Every 4 weeks up to Week 52	No
Secondary	Change in C-reactive protein (CRP)	C-reactive protein (CRP) is a protein found in the blood, the levels of which rise in response to inflammation.	From Week 0 to Week 52	No
Secondary	Change in Laboratory Test Variables	Hematology, Chemistry and Urinalysis	From Week 0 to Week 52	Yes
Secondary	Change in Vital Sign Variables	Blood pressure, heart rate, respiratory rate and body temperature	From Week 0 to Week 52	Yes
Secondary	Number of subjects with adverse events		Up to 70 days after Week 50	Yes

External Links

•   Link