Clinical trial NCT01114880: Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Keywords: ankylosing spondylitis
China
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-05-03
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

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 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

Primary outcomes:
measure: Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria
timeFrame: Week 12
Secondary outcomes:
measure: Number of Participants Meeting the ASAS20 Response Criteria
timeFrame: Week 24
measure: Number of Participants Meeting the ASAS40 Response Criteria
timeFrame: Week 12
measure: Number of Participants Meeting the ASAS40 Response Criteria
timeFrame: Week 24
measure: Number of Participants Meeting the ASAS5/6 Response Criteria
timeFrame: Week 12
measure: Number of Participants Meeting the ASAS5/6 Response Criteria
timeFrame: Week 24
measure: Number of Participants With ASAS Partial Remission
timeFrame: Week 12
measure: Number of Participants With ASAS Partial Remission
timeFrame: Week 24
measure: Change From Baseline in Patient Global Assessment of Disease Activity
timeFrame: Baseline and Week 12
measure: Change From Baseline in Patient Global Assessment of Disease Activity
timeFrame: Baseline and Week 24
measure: Change From Baseline in Total Back Pain Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in Total Back Pain Score
timeFrame: Baseline and Week 24
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
timeFrame: Baseline and Week 24
measure: Change From Baseline in Inflammation Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in Inflammation Score
timeFrame: Baseline and Week 24
measure: Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria
timeFrame: Week 12
measure: Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria
timeFrame: Week 24
measure: Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
timeFrame: Baseline and Week 12
measure: Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
timeFrame: Baseline and Week 24
measure: Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Hefei
country: China
facility: Site Reference ID/Investigator# 24054
state: Anhui
city: Beijing
country: China
facility: Site Reference ID/Investigator# 25522
city: Beijing
country: China
facility: Site Reference ID/Investigator# 24055
city: Beijing
country: China
facility: Site Reference ID/Investigator# 24052
city: Guangzhou
country: China
facility: Site Reference ID/Investigator# 24056
city: Hangzhou
country: China
facility: Site Reference ID/Investigator# 24243
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 24053
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 24058
city: Xi'an
country: China
facility: Site Reference ID/Investigator# 24057
Study officials:
affiliation: Abbott
name: Aileen Pangan
role: STUDY_DIRECTOR
References: