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Efficacy and Safety of Adalimumab in Adult Chinese 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); placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Aileen Pangan, Study Director, Affiliation: Abbott

Summary

Study of the efficacy and safety of adalimumab compared with placebo in adult Chinese participants with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)

Clinical Details

Official title: A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Study of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria

Secondary outcome:

Number of Participants Meeting the ASAS20 Response Criteria

Number of Participants Meeting the ASAS40 Response Criteria

Number of Participants Meeting the ASAS40 Response Criteria

Number of Participants Meeting the ASAS5/6 Response Criteria

Number of Participants Meeting the ASAS5/6 Response Criteria

Number of Participants With ASAS Partial Remission

Number of Participants With ASAS Partial Remission

Change From Baseline in Patient Global Assessment of Disease Activity

Change From Baseline in Patient Global Assessment of Disease Activity

Change From Baseline in Total Back Pain Score

Change From Baseline in Total Back Pain Score

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

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

Change From Baseline in Inflammation Score

Change From Baseline in Inflammation Score

Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria

Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria

Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)

Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)

Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score

Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score

Detailed description: Adults with active ankylosing spondylitis (AS) were randomized in a 2: 1 ratio to receive treatment with adalimumab 40 mg every other week (eow) or matching placebo, given subcutaneously (SC), in the 12-week double-blind (DB) phase. Randomized participants received one SC injection of the appropriate DB study medication (adalimumab 40 mg or matching placebo) at Week 0 and then eow until Week 10. Participants who completed the DB phase could enter the 12-week open-label (OL) phase, during which all participants received treatment with adalimumab 40 mg eow, starting at Weeks 12 through 22. No study drug was administered or injected at the final study visit (Week 24). A follow-up visit occurred 70 days after the last dose of study drug (in DB or OL phases) to obtain information on any ongoing or new adverse events (AEs).

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Site Reference ID/Investigator# 24052, Beijing 100853, China

Site Reference ID/Investigator# 24055, Beijing 100032, China

Site Reference ID/Investigator# 25522, Beijing 100029, China

Site Reference ID/Investigator# 24056, Guangzhou 510630, China

Site Reference ID/Investigator# 24243, Hangzhou 310009, China

Site Reference ID/Investigator# 24053, Shanghai 200001, China

Site Reference ID/Investigator# 24058, Shanghai 200003, China

Site Reference ID/Investigator# 24057, Xi'an 710032, China

Site Reference ID/Investigator# 24054, Hefei, Anhui 230022, China

Additional Information

Starting date: January 2010
Last updated: November 22, 2011

Page last updated: August 23, 2015

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