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Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
adalimumab
placebo
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring ankylosing spondylitis, China

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 24054
  • Site Reference ID/Investigator# 25522
  • Site Reference ID/Investigator# 24055
  • Site Reference ID/Investigator# 24052
  • Site Reference ID/Investigator# 24056
  • Site Reference ID/Investigator# 24243
  • Site Reference ID/Investigator# 24053
  • Site Reference ID/Investigator# 24058
  • Site Reference ID/Investigator# 24057

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Adalimumab

Arm Description

Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 24.

Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 24.

Outcomes

Primary Outcome Measures

Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria
ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).

Secondary Outcome Measures

Number of Participants Meeting the ASAS20 Response Criteria
ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).
Number of Participants Meeting the ASAS40 Response Criteria
An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).
Number of Participants Meeting the ASAS40 Response Criteria
An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).
Number of Participants Meeting the ASAS5/6 Response Criteria
An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein).
Number of Participants Meeting the ASAS5/6 Response Criteria
An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein).
Number of Participants With ASAS Partial Remission
Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).
Number of Participants With ASAS Partial Remission
Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).
Change From Baseline in Patient Global Assessment of Disease Activity
Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).
Change From Baseline in Patient Global Assessment of Disease Activity
Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).
Change From Baseline in Total Back Pain Score
Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).
Change From Baseline in Total Back Pain Score
Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.
Change From Baseline in Inflammation Score
The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: "How would you describe the overall level of morning stiffness you have had from the time you wake up?", with response ranging from none to very severe; and "How long does your morning stiffness last from the time you wake up?", with response ranging from 0 hours to 2 or more hours.
Change From Baseline in Inflammation Score
The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: "How would you describe the overall level of morning stiffness you have had from the time you wake up?", with response ranging from none to very severe; and "How long does your morning stiffness last from the time you wake up?", with response ranging from 0 hours to 2 or more hours.
Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria
A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from "none" to "very severe" or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2).
Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria
A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from "none" to "very severe" or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2).
Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.
Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.
Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score
The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.
Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score
The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.

Full Information

First Posted
February 5, 2010
Last Updated
November 22, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT01114880
Brief Title
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

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
ankylosing spondylitis, China

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
344 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 24.
Arm Title
Adalimumab
Arm Type
Experimental
Arm Description
Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 24.
Intervention Type
Biological
Intervention Name(s)
adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
Prefilled syringe, 40 mg/0.8 mL administered subcutaneously every other week
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Prefilled syringe, matching placebo administered subcutaneously every other week
Primary Outcome Measure Information:
Title
Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria
Description
ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Number of Participants Meeting the ASAS20 Response Criteria
Description
ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).
Time Frame
Week 24
Title
Number of Participants Meeting the ASAS40 Response Criteria
Description
An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).
Time Frame
Week 12
Title
Number of Participants Meeting the ASAS40 Response Criteria
Description
An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).
Time Frame
Week 24
Title
Number of Participants Meeting the ASAS5/6 Response Criteria
Description
An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein).
Time Frame
Week 12
Title
Number of Participants Meeting the ASAS5/6 Response Criteria
Description
An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein).
Time Frame
Week 24
Title
Number of Participants With ASAS Partial Remission
Description
Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).
Time Frame
Week 12
Title
Number of Participants With ASAS Partial Remission
Description
Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).
Time Frame
Week 24
Title
Change From Baseline in Patient Global Assessment of Disease Activity
Description
Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).
Time Frame
Baseline and Week 12
Title
Change From Baseline in Patient Global Assessment of Disease Activity
Description
Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).
Time Frame
Baseline and Week 24
Title
Change From Baseline in Total Back Pain Score
Description
Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).
Time Frame
Baseline and Week 12
Title
Change From Baseline in Total Back Pain Score
Description
Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).
Time Frame
Baseline and Week 24
Title
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Description
Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Description
Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Inflammation Score
Description
The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: "How would you describe the overall level of morning stiffness you have had from the time you wake up?", with response ranging from none to very severe; and "How long does your morning stiffness last from the time you wake up?", with response ranging from 0 hours to 2 or more hours.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Inflammation Score
Description
The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: "How would you describe the overall level of morning stiffness you have had from the time you wake up?", with response ranging from none to very severe; and "How long does your morning stiffness last from the time you wake up?", with response ranging from 0 hours to 2 or more hours.
Time Frame
Baseline and Week 24
Title
Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria
Description
A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from "none" to "very severe" or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2).
Time Frame
Week 12
Title
Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria
Description
A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from "none" to "very severe" or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2).
Time Frame
Week 24
Title
Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
Description
Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.
Time Frame
Baseline and Week 12
Title
Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
Description
Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.
Time Frame
Baseline and Week 24
Title
Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score
Description
The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.
Time Frame
Baseline and Week 12
Title
Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score
Description
The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.
Time Frame
Baseline and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aileen Pangan
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 24054
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Site Reference ID/Investigator# 25522
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Site Reference ID/Investigator# 24055
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Site Reference ID/Investigator# 24052
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Site Reference ID/Investigator# 24056
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Facility Name
Site Reference ID/Investigator# 24243
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
Site Reference ID/Investigator# 24053
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Site Reference ID/Investigator# 24058
City
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Site Reference ID/Investigator# 24057
City
Xi'an
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

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Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis

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