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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: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01114880
Date of registration: 05/02/2010
Prospective Registration: Yes
Primary sponsor: Abbott
Public title: Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis
Scientific title: A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Study of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis
Date of first enrolment: January 2010
Target sample size: 344
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01114880
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
China
Contacts
Name:     Aileen Pangan
Address: 
Telephone:
Email:
Affiliation:  Abbott
Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 18 through 65 years

- Has a diagnosis of ankylosing spondylitis (AS) based on the Modified New York Criteria

- Has active AS, as defined by fulfillment of at least 2 of the following 3 conditions
at both Screening and Baseline visits:

- BASDAI score at least 4 cm

- Total back pain on a visual analog scale (VAS) at least 40 mm

- Morning stiffness at least 1 hr

- Has inadequate response to or intolerance to one or more non-steroidal
anti-inflammatory drugs (NSAIDs) as defined by the Investigator

Exclusion Criteria:

- Has total spinal ankylosis (bamboo spine)

- Has undergone spinal surgery or joint surgery involving joints assessed within 2
months prior to Baseline

- Has extra-articular manifestations (i.e., psoriasis, uveitis, inflammatory bowel
disease) that is not clinically stable, as defined by the Investigator's best clinical
judgment, for at least 28 days prior to Baseline

- Has received intra-articular joint injection(s), spinal or paraspinal injection(s)
with corticosteroids within 28 days prior to Baseline

- Has prior exposure to any biologic therapy with potential therapeutic impact on AS,
including anti-TNF (tumor necrosis factor) therapy



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Intervention(s)
Biological: adalimumab
Other: placebo
Primary Outcome(s)
Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria [Time Frame: Week 12]
Secondary Outcome(s)
Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score [Time Frame: Baseline and Week 12]
Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score [Time Frame: Baseline and Week 24]
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score [Time Frame: Baseline and Week 12]
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score [Time Frame: Baseline and Week 24]
Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) [Time Frame: Baseline and Week 12]
Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) [Time Frame: Baseline and Week 24]
Change From Baseline in Inflammation Score [Time Frame: Baseline and Week 12]
Change From Baseline in Inflammation Score [Time Frame: Baseline and Week 24]
Change From Baseline in Patient Global Assessment of Disease Activity [Time Frame: Baseline and Week 12]
Change From Baseline in Patient Global Assessment of Disease Activity [Time Frame: Baseline and Week 24]
Change From Baseline in Total Back Pain Score [Time Frame: Baseline and Week 12]
Change From Baseline in Total Back Pain Score [Time Frame: Baseline and Week 24]
Number of Participants Meeting the ASAS20 Response Criteria [Time Frame: Week 24]
Number of Participants Meeting the ASAS40 Response Criteria [Time Frame: Week 12]
Number of Participants Meeting the ASAS40 Response Criteria [Time Frame: Week 24]
Number of Participants Meeting the ASAS5/6 Response Criteria [Time Frame: Week 12]
Number of Participants Meeting the ASAS5/6 Response Criteria [Time Frame: Week 24]
Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria [Time Frame: Week 12]
Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria [Time Frame: Week 24]
Number of Participants With ASAS Partial Remission [Time Frame: Week 12]
Number of Participants With ASAS Partial Remission [Time Frame: Week 24]
Secondary ID(s)
M11-991
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 04/11/2011
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01114880
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