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A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis

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

Condition(s) targeted: Ankylosing Spondylitis

Intervention: adalimumab (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Hideyuki Hashiba, BS, Study Director, Affiliation: Abbott

Summary

To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with active ankylosing spondylitis

Clinical Details

Official title: A Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis

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

Primary outcome: Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12

Secondary outcome:

Number of Subjects Achieving ASAS 20

Number of Subjects Achieving ASAS 50

Number of Subjects Achieving ASAS 70

Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50)

Mean Change From Baseline in Patient's Global Assessment of Disease Activity

Mean Change From Baseline in Total Back Pain

Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

Mean Change From Baseline in C-Reactive Protein (CRP)

Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.

Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40)

Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission

Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)

Mean Change From Baseline in Chest Expansion

Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)

Mean Change From Baseline in Nocturnal Pain

Mean Change From Baseline in Swollen Joint Count for 44 Joints (SJC 44)

Mean Change From Baseline in Tender Joint Count for 46 Joints (TJC 46)

Mean Change From Baseline in 36-Item Short Form (SF-36) Questionnaire

Detailed description: It is reported that the prevalence of Ankylosing Spondylitis (AS) in Japanese patients is extremely lower than that of Caucasians; therefore, a controlled, double-blind study with similar sample size in Western studies for active AS in Japan was not able to be conducted. As a result, this study was conducted with an open-label design to investigate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with active AS. The inclusion criteria and primary endpoint measurement (Achieving Assessment in Ankylosing Spondylitis 20 at Week 12) were designed the same as the Western studies for active AS in consideration with the confirmation of Western data. Treatment with adalimumab was to be continued until the approval of adalimumab for AS in Japanese subjects with active AS.

Eligibility

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

Criteria:

Inclusion Criteria:

- Subject who meets the definition of Ankylosing Spondylitis based on the Modified New

York Criteria, has a diagnosis of active Ankylosing Spondylitis and has had an inadequate response to or intolerance to one or more nonsteroidal anti-inflammatory drugs Exclusion Criteria:

- History of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV

- Previously received anti-TNF therapy

- Spinal surgery or joint surgery involving joints to be assessed within 2 months prior

to the Screening

Locations and Contacts

Site Reference # / Investigator 46791, Aichi, Japan

Site Reference # / Investigator 46789, Fukui, Japan

Site Reference # / Investigator 46798, Fukuoka, Japan

Site Reference # / Investigator 46799, Fukuoka, Japan

Site Reference # / Investigator 46796, Hiroshima, Japan

Site Reference # / Investigator 46782, Hokkaido, Japan

Site Reference # / Investigator 7297, Hokkaido, Japan

Site Reference # / Investigator 46795, Hyogo, Japan

Site Reference # / Investigator 46797, Kagawa, Japan

Site Reference # / Investigator 46787, Kanagawa, Japan

Site Reference # / Investigator 46790, Nagano, Japan

Site Reference # / Investigator 46793, Osaka, Japan

Site Reference # / Investigator 46794, Osaka, Japan

Site Reference # / Investigator 46783, Saitama, Japan

Site Reference # / Investigator 46784, Saitama, Japan

Site Reference # / Investigator 46792, Shiga, Japan

Site Reference # / Investigator 46785, Tokyo, Japan

Site Reference # / Investigator 46786, Tokyo, Japan

Site Reference # / Investigator 46788, Toyama, Japan

Additional Information

Starting date: February 2008
Last updated: January 24, 2012

Page last updated: August 23, 2015

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