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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 17 November 2014
Main ID:  EUCTR2014-004532-18-Outside-EU/EEA
Date of registration: 12/11/2014
Prospective Registration: Yes
Primary sponsor: Abbott
Public title: A Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis
Scientific title: A Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis
Date of first enrolment:
Target sample size: 41
Recruitment status: NA
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004532-18
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1  
Phase: 
Countries of recruitment
Japan
Contacts
Name: EU Clinical Trials Helpdesk   
Address:  Abbott House, Vanwall Business Park, Vanwall Road SL6 4XE Maidenhead United Kingdom
Telephone: +441628773355
Email: eu-clinical-trials@abbvie.com
Affiliation:  AbbVie Ltd.
Name: EU Clinical Trials Helpdesk   
Address:  Abbott House, Vanwall Business Park, Vanwall Road SL6 4XE Maidenhead United Kingdom
Telephone: +441628773355
Email: eu-clinical-trials@abbvie.com
Affiliation:  AbbVie Ltd.
Key inclusion & exclusion 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 39
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
MedDRA version: 17.1 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)
Main Objective: The Primary objective of this study is to investigate the efficacy, safety and pharmacokinetics of adalimumab subcutaneous administration every other week in Japanese patients with active ankylosing spondylitis (AS).
Primary end point(s): Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20)
Secondary Objective: The secondary objective is to confirm the similarity of data from this study to data from Study M03-607 and Study M03-606 in European and American
patients with active AS.
Timepoint(s) of evaluation of this end point: Week 12
Secondary Outcome(s)
Secondary end point(s): -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
Timepoint(s) of evaluation of this end point: •ASAS 50 [ Time Frame: Week 12 ]
•ASAS 70 [ Time Frame: Week 12 ]
•Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) [ Time Frame: Week 12 ]
•Evaluation of adverse event, vital sign and laboratory tests [ Time Frame: During study period ]
Secondary ID(s)
M10-239
NCT00667355
Source(s) of Monetary Support
Abbott
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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