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Trial record 31 of 298 for:    "Ankylosing spondylitis"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01114880
Recruitment Status : Completed
First Posted : May 3, 2010
Results First Posted : November 4, 2011
Last Update Posted : December 1, 2011
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ankylosing Spondylitis
Interventions Biological: adalimumab
Other: placebo
Enrollment 344
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adalimumab Placebo
Hide Arm/Group Description Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22 Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
Period Title: Period 1 (Week 0 to Week 12)
Started 229 115
Completed 224 113
Not Completed 5 2
Reason Not Completed
Adverse Event             4             0
Withdrawal by Subject             1             0
Lost to Follow-up             0             1
Poor subject compliance             0             1
Period Title: Period 2 (Week 12 to Week 24)
Started 224 113
Completed 221 111
Not Completed 3 2
Reason Not Completed
Adverse Event             3             0
Lost to Follow-up             0             2
Arm/Group Title Adalimumab Placebo Total
Hide Arm/Group Description Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22 Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22 Total of all reporting groups
Overall Number of Baseline Participants 229 115 344
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 229 participants 115 participants 344 participants
30.1  (8.73) 29.6  (7.49) 29.9  (8.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 229 participants 115 participants 344 participants
Female
44
  19.2%
20
  17.4%
64
  18.6%
Male
185
  80.8%
95
  82.6%
280
  81.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 229 participants 115 participants 344 participants
229 115 344
1.Primary Outcome
Title Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-Treat (ITT) analysis set, which included all subjects who were randomized and received at least 1 dose of double-blind study drug. A non-responder (NRI) imputation was used in which a missing response was imputed as non-response.
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 229 115
Measure Type: Number
Unit of Measure: participants
154 35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab/Adalimumab, Placebo/Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Meeting the ASAS20 Response Criteria
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, missing data imputed by NRI
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 224 113
Measure Type: Number
Unit of Measure: participants
180 85
3.Secondary Outcome
Title Number of Participants Meeting the ASAS40 Response Criteria
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, missing data imputed by NRI
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 229 115
Measure Type: Number
Unit of Measure: participants
102 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab/Adalimumab, Placebo/Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants Meeting the ASAS40 Response Criteria
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, missing data imputed by NRI
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 224 113
Measure Type: Number
Unit of Measure: participants
134 63
5.Secondary Outcome
Title Number of Participants Meeting the ASAS5/6 Response Criteria
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, missing data imputed by NRI
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 229 115
Measure Type: Number
Unit of Measure: participants
128 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab/Adalimumab, Placebo/Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants Meeting the ASAS5/6 Response Criteria
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, missing data imputed by NRI
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 224 113
Measure Type: Number
Unit of Measure: participants
150 69
7.Secondary Outcome
Title Number of Participants With ASAS Partial Remission
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, missing data imputed by NRI
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 229 115
Measure Type: Number
Unit of Measure: participants
50 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab/Adalimumab, Placebo/Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With ASAS Partial Remission
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, missing data imputed by NRI
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 224 113
Measure Type: Number
Unit of Measure: participants
85 33
9.Secondary Outcome
Title Change From Baseline in Patient Global Assessment of Disease Activity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, missing data imputed by last observation carried forward (LOCF)
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 229 115
Mean (Standard Deviation)
Unit of Measure: millimeters
-28.8  (24.16) -11.7  (21.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab/Adalimumab, Placebo/Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Patient Global Assessment of Disease Activity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, missing data imputed by last observation carried forward (LOCF)
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 224 113
Mean (Standard Deviation)
Unit of Measure: millimeters
-37.8  (24.47) -35.5  (25.03)
11.Secondary Outcome
Title Change From Baseline in Total Back Pain Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, LOCF
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 229 115
Mean (Standard Deviation)
Unit of Measure: millimeters
-32.0  (23.55) -13.7  (22.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab/Adalimumab, Placebo/Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Total Back Pain Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, LOCF
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 224 113
Mean (Standard Deviation)
Unit of Measure: millimeters
-42.1  (23.29) -37.8  (24.20)
13.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, LOCF
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 229 115
Mean (Standard Deviation)
Unit of Measure: units on a scale
-17.5  (20.18) -4.7  (16.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab/Adalimumab, Placebo/Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, LOCF
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 224 113
Mean (Standard Deviation)
Unit of Measure: units on a scale
-23.2  (21.03) -20.9  (21.51)
15.Secondary Outcome
Title Change From Baseline in Inflammation Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, LOCF
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 229 115
Mean (Standard Deviation)
Unit of Measure: centimeters
-2.9  (2.01) -1.5  (2.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab/Adalimumab, Placebo/Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Inflammation Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, LOCF
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 224 113
Mean (Standard Deviation)
Unit of Measure: centimeters
-3.6  (2.21) -3.6  (2.24)
17.Secondary Outcome
Title Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, missing data imputed by NRI
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 229 115
Measure Type: Number
Unit of Measure: participants
114 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab/Adalimumab, Placebo/Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
18.Secondary Outcome
Title Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, missing data imputed by NRI
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 224 113
Measure Type: Number
Unit of Measure: participants
156 71
19.Secondary Outcome
Title Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, LOCF
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 229 115
Mean (Standard Deviation)
Unit of Measure: milligrams/liter
-17.8  (23.76) -4.2  (21.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab/Adalimumab, Placebo/Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, LOCF
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 224 113
Mean (Standard Deviation)
Unit of Measure: milligrams/liter
-18.2  (24.27) -20.1  (30.63)
21.Secondary Outcome
Title Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, observed cases
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 226 113
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.6  (6.43) 4.0  (6.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab/Adalimumab, Placebo/Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set, observed cases
Arm/Group Title Adalimumab/Adalimumab Placebo/Adalimumab
Hide Arm/Group Description:
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
Overall Number of Participants Analyzed 222 110
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.6  (7.44) 9.2  (7.25)
Time Frame All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adalimumab (Period 1) Placebo (Period 1) Adalimumab/Adalimumab (Period 2) Placebo/Adalimumab (Period 2)
Hide Arm/Group Description Blinded adalimumab from Week 0 to Week 10 Blinded placebo from Week 0 to Week 10 Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded adalimumab from Week 0 to Week 10 Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded placebo from Week 0 to Week 10
All-Cause Mortality
Adalimumab (Period 1) Placebo (Period 1) Adalimumab/Adalimumab (Period 2) Placebo/Adalimumab (Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab (Period 1) Placebo (Period 1) Adalimumab/Adalimumab (Period 2) Placebo/Adalimumab (Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/229 (0.44%)   1/115 (0.87%)   3/224 (1.34%)   1/113 (0.88%) 
Infections and infestations         
Hepatitis viral * 1  0/229 (0.00%)  0/115 (0.00%)  0/224 (0.00%)  1/113 (0.88%) 
Pelvic inflammatory disease * 1  1/229 (0.44%)  0/115 (0.00%)  0/224 (0.00%)  0/113 (0.00%) 
Peritoneal tuberculosis * 1 [1]  0/229 (0.00%)  0/115 (0.00%)  1/224 (0.45%)  0/113 (0.00%) 
Pulmonary tuberculosis * 1  0/229 (0.00%)  0/115 (0.00%)  1/224 (0.45%)  0/113 (0.00%) 
Tuberculosis pleurisy * 1  0/229 (0.00%)  0/115 (0.00%)  1/224 (0.45%)  0/113 (0.00%) 
Injury, poisoning and procedural complications         
Concussion * 1 [2]  0/229 (0.00%)  0/115 (0.00%)  1/224 (0.45%)  0/113 (0.00%) 
Contusion * 1  0/229 (0.00%)  0/115 (0.00%)  1/224 (0.45%)  0/113 (0.00%) 
Skin laceration * 1  0/229 (0.00%)  0/115 (0.00%)  1/224 (0.45%)  0/113 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Fibroadenoma of breast * 1  0/229 (0.00%)  1/115 (0.87%)  0/224 (0.00%)  0/113 (0.00%) 
Intraductal papilloma of breast * 1  0/229 (0.00%)  1/115 (0.87%)  0/224 (0.00%)  0/113 (0.00%) 
Surgical and medical procedures         
Abortion induced * 1  0/229 (0.00%)  0/115 (0.00%)  1/224 (0.45%)  0/113 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
[1]
Note: One subject had 3 tuberculosis-related adverse events (peritoneal tuberculosis, pulmonary tuberculosis, and tuberculous pleurisy).
[2]
Note: One subject had 3 injury-related adverse events (concussion, contusion, and skin laceration).
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Adalimumab (Period 1) Placebo (Period 1) Adalimumab/Adalimumab (Period 2) Placebo/Adalimumab (Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   55/229 (24.02%)   16/115 (13.91%)   32/224 (14.29%)   22/113 (19.47%) 
Blood and lymphatic system disorders         
Thrombocytopenia * 1  3/229 (1.31%)  0/115 (0.00%)  1/224 (0.45%)  0/113 (0.00%) 
Gastrointestinal disorders         
Epigastric discomfort * 1  3/229 (1.31%)  0/115 (0.00%)  0/224 (0.00%)  0/113 (0.00%) 
General disorders         
Injection site erythema * 1  4/229 (1.75%)  0/115 (0.00%)  0/224 (0.00%)  1/113 (0.88%) 
Injection site swelling * 1  1/229 (0.44%)  0/115 (0.00%)  0/224 (0.00%)  2/113 (1.77%) 
Infections and infestations         
Nasopharyngitis * 1  4/229 (1.75%)  2/115 (1.74%)  1/224 (0.45%)  0/113 (0.00%) 
Upper respiratory tract infection * 1  13/229 (5.68%)  9/115 (7.83%)  13/224 (5.80%)  8/113 (7.08%) 
Investigations         
Alanine aminotransferase increased * 1  26/229 (11.35%)  2/115 (1.74%)  11/224 (4.91%)  13/113 (11.50%) 
Aspartate aminotransferase increased * 1  20/229 (8.73%)  1/115 (0.87%)  6/224 (2.68%)  9/113 (7.96%) 
Blood alkaline phosphatase increased * 1  3/229 (1.31%)  0/115 (0.00%)  0/224 (0.00%)  2/113 (1.77%) 
Blood bilirubin increased * 1  0/229 (0.00%)  0/115 (0.00%)  4/224 (1.79%)  0/113 (0.00%) 
Blood triglycerides increased * 1  3/229 (1.31%)  1/115 (0.87%)  2/224 (0.89%)  2/113 (1.77%) 
Platelet count decreased * 1  2/229 (0.87%)  0/115 (0.00%)  4/224 (1.79%)  0/113 (0.00%) 
White blood cell count decreased * 1  6/229 (2.62%)  2/115 (1.74%)  2/224 (0.89%)  1/113 (0.88%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  3/229 (1.31%)  1/115 (0.87%)  0/224 (0.00%)  0/113 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis allergic * 1  3/229 (1.31%)  0/115 (0.00%)  1/224 (0.45%)  1/113 (0.88%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott
Phone: 1-800-633-9110
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01114880     History of Changes
Other Study ID Numbers: M11-991
First Submitted: February 5, 2010
First Posted: May 3, 2010
Results First Submitted: September 29, 2011
Results First Posted: November 4, 2011
Last Update Posted: December 1, 2011