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Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis

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: NCT01646073
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : January 19, 2015
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Biological: Adalimumab
Biological: placebo
Enrollment 425
Recruitment Details  
Pre-assignment Details Participants were randomized at Week 0 (Day 1) in a 4:1 ratio to receive either adalimumab every other week (eow) or matching placebo.
Arm/Group Title Placebo Adalimumab Eow
Hide Arm/Group Description Participants were started on placebo in Period A and then switched to adalimumab 40 mg eow in Period B Participants were started on 40 mg adalimumab every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B
Period Title: Period A (12 Weeks)
Started 87 338
Completed 85 333
Not Completed 2 5
Reason Not Completed
Adverse Event             0             2
Withdrawal by Subject             1             1
Lack of Efficacy             1             0
Protocol Violation             0             1
Not Specified             0             1
Period Title: Period B (12 Weeks)
Started 85 333
Completed 84 320
Not Completed 1 13
Reason Not Completed
Adverse Event             0             7
Withdrawal by Subject             1             5
Lost to Follow-up             0             1
Arm/Group Title Placebo Adalimumab Eow Total
Hide Arm/Group Description Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B Participants were started on adalimumab 40 mg every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B Total of all reporting groups
Overall Number of Baseline Participants 87 338 425
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 338 participants 425 participants
43.8  (12.45) 43.1  (11.91) 43.2  (12.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 338 participants 425 participants
Female
29
  33.3%
84
  24.9%
113
  26.6%
Male
58
  66.7%
254
  75.1%
312
  73.4%
Duration of Psoriasis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 338 participants 425 participants
15.79  (10.309) 14.84  (10.114) 15.03  (10.149)
Body Surface Area with Psoriasis  
Mean (Standard Deviation)
Unit of measure:  Percentage of Body Surface Area
Number Analyzed 87 participants 338 participants 425 participants
39.30  (22.502) 42.62  (21.748) 41.94  (21.918)
Psoriasis Area and Severity Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 87 participants 338 participants 425 participants
25.60  (10.978) 28.19  (11.999) 27.66  (11.831)
[1]
Measure Description: Psoriasis Area and Severity Index (PASI) is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Physician's Global Assessment of Psoriasis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 87 participants 338 participants 425 participants
Clear 0 0 0
Minimal 0 0 0
Mild 0 0 0
Moderate 57 214 271
Marked 28 110 138
Severe 2 14 16
1.Primary Outcome
Title Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12
Hide Description The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population A (ITT_A): all participants who were randomized at Week 0 (Baseline); Non-responder imputation (NRI): any participant who had a missing value at a specific visit as non-responder for that visit.
Arm/Group Title Placebo Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A (Week 0 to Week 12).
Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Overall Number of Participants Analyzed 87 338
Measure Type: Number
Unit of Measure: percentage of participants
11.5 77.8
2.Secondary Outcome
Title Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A]
Hide Description The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI), other than Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Time Frame Weeks 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.
Arm/Group Title Placebo Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A (Week 0 to Week 12).
Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Overall Number of Participants Analyzed 87 338
Measure Type: Number
Unit of Measure: percentage of participants
Week 3 0 9.8
Week 7 2.3 45.3
3.Secondary Outcome
Title Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B]
Hide Description The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Time Frame Weeks 16, 19, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population B (ITT_B): all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.
Arm/Group Title Placebo/Adalimumab Eow Adalimumab Eow/Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Overall Number of Participants Analyzed 85 333
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 51.8 87.4
Week 19 80.0 87.1
Week 24 90.6 87.7
4.Secondary Outcome
Title Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A]
Hide Description Psoriasis Area and Severity Index (PASI), is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT_A: all participants that were randomized in Week 0 (Baseline); Last observation carried forward (LOCF): used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.
Arm/Group Title Placebo Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A (Week 0 to Week 12).
Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Overall Number of Participants Analyzed 87 336
Mean (Standard Error)
Unit of Measure: Percent change
-20.44  (3.049) -82.20  (1.548)
5.Secondary Outcome
Title Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B]
Hide Description PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT_B: all participants who received at least 1 dose of study drug in Period B; LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.
Arm/Group Title Placebo/Adalimumab Eow Adalimumab Eow/Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Overall Number of Participants Analyzed 85 333
Mean (Standard Deviation)
Unit of Measure: percent change
-91.39  (14.423) -91.07  (19.028)
6.Secondary Outcome
Title Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A]
Hide Description The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Time Frame Weeks 3, 7, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.
Arm/Group Title Placebo Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A (Week 0 to Week 12).
Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Overall Number of Participants Analyzed 87 338
Measure Type: Number
Unit of Measure: percentage of participants
PASI 50 [Week 3] 1.1 31.7
PASI 90 [Week 3] 0 2.7
PASI 100 [Week 3] 0 0
PASI 50 [Week 7] 11.5 77.2
PASI 90 [Week 7] 0 23.4
PASI 100 [Week 7] 0 3.8
PASI 50 [Week 12] 23.0 88.8
PASI 90 [Week 12] 3.4 55.6
PASI 100 [Week 12] 1.1 13.3
7.Secondary Outcome
Title Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B]
Hide Description The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Time Frame Weeks 16, 19, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.
Arm/Group Title Placebo/Adalimumab Eow Adalimumab Eow/Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Overall Number of Participants Analyzed 85 333
Measure Type: Number
Unit of Measure: percentage of participants
PASI 50 [Week 16] 71.8 93.4
PASI 90 [Week 16] 28.2 70.0
PASI 100 [Week 16] 8.2 20.4
PASI 50 [Week 19] 92.9 94.3
PASI 90 [Week 19] 56.5 74.2
PASI 100 [Week 19] 22.4 28.8
PASI 50 [Week 24] 94.1 91.9
PASI 90 [Week 24] 75.3 76.3
PASI 100 [Week 24] 34.1 35.7
8.Secondary Outcome
Title Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” [Period A]
Hide Description The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'
Time Frame Baseline and Weeks 3, 7, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.
Arm/Group Title Placebo Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A (Week 0 to Week 12).
Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Overall Number of Participants Analyzed 87 338
Measure Type: Number
Unit of Measure: percentage of participants
Baseline 0 0
Week 3 0 0.6
Week 7 0 12.1
Week 12 1.1 25.7
9.Secondary Outcome
Title Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” [Period B]
Hide Description The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'
Time Frame Weeks 16, 19, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.
Arm/Group Title Placebo/Adalimumab Eow Adalimumab Eow/Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Overall Number of Participants Analyzed 85 333
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 14.1 39.3
Week 19 29.4 42.9
Week 24 41.2 45.6
10.Secondary Outcome
Title Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” or “Minimal” [Period A]
Hide Description The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'
Time Frame Baseline and Weeks 3, 7, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.
Arm/Group Title Placebo Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A (Week 0 to Week 12).
Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Overall Number of Participants Analyzed 87 338
Measure Type: Number
Unit of Measure: percentage of participants
Baseline 0 0
Week 3 0 20.1
Week 7 4.6 57.4
Week 12 14.9 80.5
11.Secondary Outcome
Title Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” or “Minimal” [Period B]
Hide Description The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'
Time Frame Weeks 16, 19, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.
Arm/Group Title Placebo/Adalimumab Eow Adalimumab Eow/Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Overall Number of Participants Analyzed 85 333
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 61.2 85.6
Week 19 84.7 84.4
Week 24 89.4 83.8
12.Secondary Outcome
Title Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period A]
Hide Description The DLQI measures how much a subject's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.
Time Frame Baseline, Week 3, and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.
Arm/Group Title Placebo Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A (Week 0 to Week 12).
Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Overall Number of Participants Analyzed 87 338
Measure Type: Number
Unit of Measure: percentage of participants
Baseline 0 0.9
Week 3 1.1 3.3
Week 12 0 13
13.Secondary Outcome
Title Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period B]
Hide Description The DLQI measures how much a participant's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.
Time Frame Week 16 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.
Arm/Group Title Placebo/Adalimumab Eow Adalimumab Eow/Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Overall Number of Participants Analyzed 85 333
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 12.9 15.0
Week 24 23.5 19.5
14.Secondary Outcome
Title Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period A]
Hide Description The DLQI measures how much a subject's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.
Time Frame Baseline, Week 3, and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.
Arm/Group Title Placebo Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A (Week 0 to Week 12).
Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Overall Number of Participants Analyzed 87 338
Measure Type: Number
Unit of Measure: percentage of participants
Baseline 1.1 2.4
Week 3 3.4 9.2
Week 12 10.3 28.4
15.Secondary Outcome
Title Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period B]
Hide Description The DLQI measures how much a participant's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.
Time Frame Week 16 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.
Arm/Group Title Placebo/Adalimumab Eow Adalimumab Eow/Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Overall Number of Participants Analyzed 85 333
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 27.1 30.0
Week 24 44.7 37.8
16.Secondary Outcome
Title Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A]
Hide Description Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. The difference from baseline to week 12 in SF-36 PCS and MCS was calculated.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT_A: all participants that were randomized in Week 0 (Baseline); LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.
Arm/Group Title Placebo Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A (Week 0 to Week 12).
Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
Overall Number of Participants Analyzed 84 335
Mean (Standard Error)
Unit of Measure: scores on a scale
Physical Component Summary 1.13  (0.665) 4.22  (0.332)
Mental Component Summary 1.91  (0.913) 7.02  (0.456)
17.Secondary Outcome
Title Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B]
Hide Description Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. The difference from baseline to week 12 in SF-36 PCS and MCS was calculated.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT_B: all participants who received at least 1 dose of study drug in Period B; LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.
Arm/Group Title Placebo/Adalimumab Eow Adalimumab Eow/Adalimumab Eow
Hide Arm/Group Description:
Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
Overall Number of Participants Analyzed 84 332
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Physical Component Summary 4.20  (8.351) 4.73  (8.260)
Mental Component Summary 5.74  (12.661) 7.76  (11.652)
Time Frame Baseline up to 70 days after last dose (week 24).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Double-blind Placebo Double-blind Adalimumab Eow Any Adalimumab
Hide Arm/Group Description Participants were started on placebo in Period A (Week 0 to Week 12) Participants were started on adalimumab eow in Period A (Week 0 to Week 12) Participants that received at least one dose of adalimumab during Period A or Period B
All-Cause Mortality
Double-blind Placebo Double-blind Adalimumab Eow Any Adalimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Double-blind Placebo Double-blind Adalimumab Eow Any Adalimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/87 (3.45%)   4/338 (1.18%)   15/423 (3.55%) 
Cardiac disorders       
ARRHYTHMIA  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
CARDIAC FAILURE CONGESTIVE  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
MYOCARDIAL INFARCTION  1  0/87 (0.00%)  1/338 (0.30%)  1/423 (0.24%) 
MYOCARDITIS  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
Congenital, familial and genetic disorders       
PYLORIC STENOSIS  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
Eye disorders       
RETINAL DETACHMENT  1  1/87 (1.15%)  0/338 (0.00%)  0/423 (0.00%) 
Gastrointestinal disorders       
GASTRIC ULCER  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
Infections and infestations       
LUNG INFECTION  1  0/87 (0.00%)  0/338 (0.00%)  2/423 (0.47%) 
LYMPH NODE TUBERCULOSIS  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
PNEUMONIA  1  0/87 (0.00%)  0/338 (0.00%)  2/423 (0.47%) 
TUBERCULOSIS  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
Injury, poisoning and procedural complications       
LUMBAR VERTEBRAL FRACTURE  1  0/87 (0.00%)  1/338 (0.30%)  1/423 (0.24%) 
SKIN INJURY  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
TIBIA FRACTURE  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
INTERVERTEBRAL DISC PROTRUSION  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
PSORIATIC ARTHROPATHY  1  1/87 (1.15%)  0/338 (0.00%)  0/423 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
ENDOMETRIAL CANCER  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
GASTRIC CANCER  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
Nervous system disorders       
CEREBRAL INFARCTION  1  0/87 (0.00%)  1/338 (0.30%)  1/423 (0.24%) 
Renal and urinary disorders       
HAEMATURIA  1  0/87 (0.00%)  1/338 (0.30%)  1/423 (0.24%) 
Respiratory, thoracic and mediastinal disorders       
PLEURAL EFFUSION  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
PLEURAL FIBROSIS  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
Skin and subcutaneous tissue disorders       
ERYTHEMA MULTIFORME  1  0/87 (0.00%)  0/338 (0.00%)  1/423 (0.24%) 
PSORIASIS  1  1/87 (1.15%)  0/338 (0.00%)  0/423 (0.00%) 
Vascular disorders       
HYPERTENSION  1  0/87 (0.00%)  1/338 (0.30%)  1/423 (0.24%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Double-blind Placebo Double-blind Adalimumab Eow Any Adalimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/87 (16.09%)   64/338 (18.93%)   137/423 (32.39%) 
Infections and infestations       
NASOPHARYNGITIS  1  5/87 (5.75%)  13/338 (3.85%)  38/423 (8.98%) 
UPPER RESPIRATORY TRACT INFECTION  1  6/87 (6.90%)  34/338 (10.06%)  68/423 (16.08%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  1  4/87 (4.60%)  11/338 (3.25%)  27/423 (6.38%) 
OROPHARYNGEAL PAIN  1  1/87 (1.15%)  14/338 (4.14%)  30/423 (7.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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.
AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01646073     History of Changes
Other Study ID Numbers: M13-606
First Submitted: July 18, 2012
First Posted: July 20, 2012
Results First Submitted: December 19, 2014
Results First Posted: January 19, 2015
Last Update Posted: January 19, 2015