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MSB11022 in Moderate to Severe Chronic Plaque Psoriasis (AURIEL-PsO)

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ClinicalTrials.gov Identifier: NCT02660580
Recruitment Status : Completed
First Posted : January 21, 2016
Results First Posted : February 19, 2019
Last Update Posted : July 1, 2019
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
Fresenius Kabi SwissBioSim GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Psoriasis
Plaque Type Psoriasis
Moderate to Severe Plaque Psoriasis
Interventions Drug: MSB11022
Drug: Humira®
Enrollment 443
Recruitment Details  
Pre-assignment Details Participants were randomized to either MSB11022 or EU-Humira in Core Treatment Period till Week 16. Participants who achieved PASI50 at Week 16 entered Extension Period where participants in MSB11022 were continued to receive MSB11022 & participants in EU-Humira were re-randomized to receive either MSB11022 or EU-Humira for additional 37 weeks.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period. Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period. Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period. Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period. Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Period Title: Core Treatment Period (Week 1 to 16)
Started 222 221 0 0 0
Treated 221 220 0 0 0
Completed 213 202 0 0 0
Not Completed 9 19 0 0 0
Reason Not Completed
Randomized, not treated             1             1             0             0             0
Protocol Violation             3             1             0             0             0
Other un-specified             1             0             0             0             0
Lack of Efficacy             0             2             0             0             0
Adverse Event             2             9             0             0             0
Withdrawal by Subject             1             4             0             0             0
Lost to Follow-up             1             2             0             0             0
Period Title: Extended Treatment Period(Week 16 to 52)
Started 0 0 213 101 101
Completed 0 0 195 90 90
Not Completed 0 0 18 11 11
Reason Not Completed
Protocol Violation             0             0             2             0             1
Other un-specified             0             0             1             0             1
Lack of Efficacy             0             0             4             2             2
Adverse Event             0             0             8             6             4
Withdrawal by Subject             0             0             3             2             2
Lost to Follow-up             0             0             0             1             1
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira Total
Hide Arm/Group Description Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period. Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period. Total of all reporting groups
Overall Number of Baseline Participants 222 221 443
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 222 participants 221 participants 443 participants
44.5  (12.8) 42.7  (12.0) 43.6  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 221 participants 443 participants
Female
75
  33.8%
73
  33.0%
148
  33.4%
Male
147
  66.2%
148
  67.0%
295
  66.6%
Race  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 221 participants 443 participants
White
205
  92.3%
200
  90.5%
405
  91.4%
Black or African American
2
   0.9%
1
   0.5%
3
   0.7%
Asian
5
   2.3%
9
   4.1%
14
   3.2%
American Indian or Alaska Native
10
   4.5%
8
   3.6%
18
   4.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Other
0
   0.0%
1
   0.5%
1
   0.2%
Missing/Not collected at this site
0
   0.0%
2
   0.9%
2
   0.5%
Ethnicity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 221 participants 443 participants
Hispanic or Latino
23
  10.4%
23
  10.4%
46
  10.4%
Not Hispanic or Latino
199
  89.6%
196
  88.7%
395
  89.2%
Missing
0
   0.0%
2
   0.9%
2
   0.5%
1.Primary Outcome
Title Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI-75 response is defined as the percentage of participants who achieved at least a 75% improvement in PASI score from Baseline.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol (PP) Analysis Set included all randomized and treated participants who did not have any major protocol deviations during the Core Treatment Period with respect to factors likely to affect the efficacy of treatment.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 203 191
Measure Type: Number
Unit of Measure: Percentage of Participants
89.7 91.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MSB11022 (Core Treatment Period), EU-Humira
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments MSB11022 was considered equivalent to EU-Humira if the 95% stratified Newcombe Confidence Interval (CI) for the difference in percentage was included in the equivalence interval (-18, 18).
Method of Estimation Estimation Parameter Percentage difference
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-7.82 to 4.07
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline in PASI at Week 16
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Percent change from Baseline in PASI score was reported.
Time Frame Baseline (Day 1 of Core Treatment Period), Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The PP Analysis set was used.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 203 191
Mean (Standard Deviation)
Unit of Measure: Percent change
-90.6  (11.3) -91.7  (9.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MSB11022 (Core Treatment Period), EU-Humira
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments MSB11022 was considered equivalent to EU-Humira if the 95% CI for the treatment difference was included in the equivalence interval [-15%, 15%]).
Method of Estimation Estimation Parameter Least Square (LS) Mean difference
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
-1.21 to 2.98
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI 50, 90 and 100 response rate at Week 16 is measured as the percentage of participants who achieved at least 50, 90 and 100% improvement from baseline PASI score at Week 16.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis set was used.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 203 191
Measure Type: Number
Unit of Measure: Percentage of Participants
PASI 50 100.0 100.0
PASI 90 64.0 66.0
PASI 100 33.0 37.2
4.Secondary Outcome
Title Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI response rate at Week 24 is measured as the percentage of participants who achieved at least 50, 75, 90 and 100% improvement from baseline PASI at Week 24.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Extended Treatment Period (ETP)-PP Analysis Set included participants who were in PP Analysis Set & were re-randomized & received treatment in Extended Treatment Period. Here "Number of participants analyzed" signifies those who were evaluable for this outcome measure.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 200 94 92
Measure Type: Number
Unit of Measure: Percentage of Participants
PASI 50 100.0 98.9 100.0
PASI 75 92.5 88.3 94.6
PASI 90 74.0 78.7 80.4
PASI 100 42.5 37.2 35.9
5.Secondary Outcome
Title Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI response rate at Week 52 is measured as the percentage of participants who achieved at least 50, 75, 90 and 100% improvement from baseline PASI at Week 52.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The ETP-PP Analysis Set was used. Here "Number of participants analyzed" signifies those who were evaluable for this outcome measure.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 186 85 87
Measure Type: Number
Unit of Measure: Percentage of Participants
PASI 50 97.8 100.0 100.0
PASI 75 90.9 92.9 93.1
PASI 90 76.3 78.8 85.1
PASI 100 53.8 54.1 57.5
6.Secondary Outcome
Title Percent Change From Baseline in PASI at Week 24 and 52
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity.
Time Frame Baseline (Day 1 of Extended Treatment Period), Weeks 24 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The ETP-PP analysis set was used. Here "Number analyzed" Signifies those participants who were evaluable for this outcome measure at specified time points.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 203 95 96
Geometric Mean (Standard Deviation)
Unit of Measure: Percent change
Week 24 Number Analyzed 200 participants 94 participants 92 participants
-92.9  (9.9) -91.3  (12.7) -94.2  (8.2)
Week 52 Number Analyzed 186 participants 85 participants 87 participants
-92.8  (13.6) -93.9  (9.6) -94.8  (9.7)
7.Secondary Outcome
Title Number of Participants With Change From Baseline in Physician’s Global Assessment (PGA) Score to “Clear” or “Almost Clear” at Week 16
Hide Description PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates Clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates Mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates Moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates Severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).
Time Frame Baseline (Day 1 of Core Treatment Period), Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
PP Analysis set was used. Number of participants with PGA response of Clear or Almost clear at Week 16 were presented.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 203 191
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline: Moderate; Week 16: Clear
52
  25.6%
51
  26.7%
Baseline: Moderate; Week 16: Almost clear
76
  37.4%
59
  30.9%
Baseline: Severe; Week 16: Clear
16
   7.9%
20
  10.5%
Baseline: Severe; Week 16: Almost clear
27
  13.3%
26
  13.6%
8.Secondary Outcome
Title Number of Participants With Change From Baseline in Physician’s Global Assessment (PGA) Score to “Clear” or “Almost Clear” at Week 24 and 52
Hide Description PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).
Time Frame Baseline (Day 1 of Extended Treatment Period), Week 24 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ETP-PP Analysis set was used. Here "Number analyzed" indicates number of participants who were evaluable for this outcome measure at specified category. Number of participants with PGA response of Clear or Almost clear at Week 24 and 52 were presented.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 203 95 96
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline: Moderate; Week 24: Clear Number Analyzed 200 participants 94 participants 92 participants
69
  34.5%
25
  26.6%
25
  27.2%
Baseline: Moderate; Week 24: AlmostClear Number Analyzed 200 participants 94 participants 92 participants
52
  26.0%
24
  25.5%
31
  33.7%
Baseline: Severe; Week 24: Clear Number Analyzed 200 participants 94 participants 92 participants
18
   9.0%
11
  11.7%
9
   9.8%
Baseline: Severe; Week 24: Almost Clear Number Analyzed 200 participants 94 participants 92 participants
27
  13.5%
14
  14.9%
13
  14.1%
Baseline: Moderate; Week 52: Clear Number Analyzed 188 participants 85 participants 87 participants
74
  39.4%
29
  34.1%
34
  39.1%
Baseline: Moderate; Week 52: AlmostClear Number Analyzed 188 participants 85 participants 87 participants
40
  21.3%
13
  15.3%
16
  18.4%
Baseline: Severe; Week 52: Clear Number Analyzed 188 participants 85 participants 87 participants
29
  15.4%
17
  20.0%
16
  18.4%
Baseline: Severe; Week 52: Almost Clear Number Analyzed 188 participants 85 participants 87 participants
15
   8.0%
6
   7.1%
6
   6.9%
9.Secondary Outcome
Title Time to Achieve PASI 50
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 50% improvement in PASI from baseline was measured.
Time Frame Baseline (Day 1 of Core Treatment Period) up to Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis set was used.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 203 191
Median (Full Range)
Unit of Measure: Months
1.6
(0.2 to 3.7)
1.6
(0.2 to 3.5)
10.Secondary Outcome
Title Time to Achieve PASI 75
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 75% improvement in PASI from baseline was measured.
Time Frame Baseline (Day 1 of Core Treatment Period) up to Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis set was used.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 203 191
Median (Full Range)
Unit of Measure: Months
2.5
(0.2 to 3.5)
1.7
(0.7 to 3.7)
11.Secondary Outcome
Title Time to Achieve PASI 90
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 90% improvement in PASI from baseline was measured.
Time Frame Baseline (Day 1 of Core Treatment Period) up to Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis set was used.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 203 191
Median (Full Range)
Unit of Measure: Months
3.4
(0.7 to 3.5)
2.6
(1.4 to 3.7)
12.Secondary Outcome
Title Time to Achieve PASI 100
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 100% improvement in PASI from baseline was measured.
Time Frame Baseline (Day 1 of Core Treatment Period) up to Month 13.5
Hide Outcome Measure Data
Hide Analysis Population Description
ETP-PP analysis set was used.
Arm/Group Title MSB11022 (Overall Treatment Period) EU-Humira/EU-Humira (Overall Treatment Period) EU-Humira/MSB11022 (Overall Treatment Period)
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 1 up to and including Week 50 in overall treatment period.
Participants who received EU-Humira up to Week 16 continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in overall treatment period.
Participants who received EU-Humira up to Week 16 were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in overall treatment period.
Overall Number of Participants Analyzed 203 95 96
Median (Full Range)
Unit of Measure: Month
7.2
(0.7 to 11.8)
7.2
(1.6 to 11.8)
8.9
(1.6 to 11.8)
13.Secondary Outcome
Title Number of Participants With Change in Physician’s Global Assessment (PGA) From Baseline at Week 16
Hide Description PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).
Time Frame Baseline (Day 1 of Core Treatment Period), Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
PP Analysis set was used. Only categories for which participants recorded a PGA response were included below.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 203 191
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline- Moderate; Week 16- Clear
52
  25.6%
51
  26.7%
Baseline- Moderate; Week 16- Almost Clear
76
  37.4%
59
  30.9%
Baseline- Moderate; Week 16- Mild
16
   7.9%
17
   8.9%
Baseline- Moderate; Week 16- Moderate
2
   1.0%
1
   0.5%
Baseline- Severe; Week 16- Clear
16
   7.9%
20
  10.5%
Baseline- Severe; Week 16- Almost Clear
27
  13.3%
26
  13.6%
Baseline- Severe; Week 16- Mild
12
   5.9%
16
   8.4%
Baseline- Severe; Week 16- Moderate
2
   1.0%
1
   0.5%
14.Secondary Outcome
Title Number of Participants With Change in Physician’s Global Assessment (PGA) From Baseline at Week 24
Hide Description PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).
Time Frame Baseline (Day 1 of Extended Treatment Period), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ETP-PP Analysis set was used. Only categories for which participants recorded a PGA response were included below. Here "Number of participants analyzed" signifies those who were evaluable for this outcome measure.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 200 94 92
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline- Moderate; Week 24- Clear
69
  34.5%
25
  26.6%
25
  27.2%
Baseline- Moderate; Week 24- Almost Clear
52
  26.0%
24
  25.5%
31
  33.7%
Baseline- Moderate; Week 24- Mild
21
  10.5%
10
  10.6%
7
   7.6%
Baseline- Moderate; Week 24- Moderate
2
   1.0%
2
   2.1%
0
   0.0%
Baseline- Severe; Week 24- Clear
18
   9.0%
11
  11.7%
9
   9.8%
Baseline- Severe; Week 24- Almost Clear
27
  13.5%
14
  14.9%
13
  14.1%
Baseline- Severe; Week 24- Mild
9
   4.5%
6
   6.4%
6
   6.5%
Baseline- Severe; Week 24- Moderate
2
   1.0%
1
   1.1%
1
   1.1%
Baseline- Severe; Week 24- Severe
0
   0.0%
1
   1.1%
0
   0.0%
15.Secondary Outcome
Title Number of Participants With Change in Physician’s Global Assessment (PGA) From Baseline at Week 52
Hide Description PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).
Time Frame Baseline (Day 1 of Extended Treatment Period), Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ETP-PP Analysis set was used. Here "Number of participants analyzed" signifies those who were evaluable for this outcome measure. Only categories for which participants recorded a PGA response were included below.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 188 85 87
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline- Moderate; Week 52- Clear
74
  39.4%
29
  34.1%
34
  39.1%
Baseline- Moderate; Week 52- Almost Clear
40
  21.3%
13
  15.3%
16
  18.4%
Baseline- Moderate; Week 52- Mild
17
   9.0%
11
  12.9%
6
   6.9%
Baseline- Moderate; Week 52- Moderate
4
   2.1%
0
   0.0%
4
   4.6%
Baseline- Moderate; Week 52- Missing
1
   0.5%
0
   0.0%
0
   0.0%
Baseline- Severe; Week 52- Clear
29
  15.4%
17
  20.0%
16
  18.4%
Baseline- Severe; Week 52- Almost Clear
15
   8.0%
6
   7.1%
6
   6.9%
Baseline- Severe; Week 52- Mild
3
   1.6%
7
   8.2%
3
   3.4%
Baseline- Severe; Week 52- Moderate
3
   1.6%
2
   2.4%
2
   2.3%
Baseline- Severe; Week 52- Severe
1
   0.5%
0
   0.0%
0
   0.0%
Baseline- Severe; Week 52- Missing
1
   0.5%
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16
Hide Description Adverse event(AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs.
Time Frame Baseline (Day 1 of Core Treatment Period) up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety (SAF) Analysis Set included all randomized participants who received at least 1 dose of MSB11022 or EU-Humira. Participants in SAF were analyzed according to actual treatment received initially during the relevant treatment period.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 221 220
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with TEAEs
114
  51.6%
117
  53.2%
Participants with Serious TEAEs
8
   3.6%
6
   2.7%
Participants with TEAEs of special interest
2
   0.9%
3
   1.4%
Participants with TEAEs Leading to Death
0
   0.0%
0
   0.0%
17.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54
Hide Description Adverse event(AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs.
Time Frame Baseline (Day 1 of Extended Treatment Period) up to Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
ETP-SAF Analysis Set was used. Participants were analyzed according to actual treatment received initially during the relevant treatment period.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 213 101 101
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with TEAEs
142
  66.7%
65
  64.4%
63
  62.4%
Participants with Serious TEAEs
12
   5.6%
3
   3.0%
4
   4.0%
Participants with TEAEs of special interest
10
   4.7%
1
   1.0%
4
   4.0%
Participants with TEAEs Leading to Death
0
   0.0%
1
   1.0%
0
   0.0%
18.Secondary Outcome
Title Number of Participants With Clinically Meaningful Differences in Laboratory Values
Hide Description Based on categories of low, normal, or high according to the laboratory normal ranges, there were no clinically meaningful differences across the treatment groups in the numbers of participants with shifts in Laboratory parameters including hematology, chemistry and urinalysis from normal at Core Baseline to either low or high during the overall treatment period. Clinical meaningful was determined by the investigator.
Time Frame Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAF) was used for up to Week 16. The ETP-SAF was used in Extended Treatment Period.
Arm/Group Title MSB11022 (Core Treatment Period) MSB11022 (Extended Treatment Period) EU-Humira EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 221 213 220 101 101
Measure Type: Count of Participants
Unit of Measure: Participants
Laboratory Values
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16
Hide Description Number of participants ANA and anti-ds DNA values were reported. For ANA, positivity is defined as any participants with ANA titer greater than (>) 1:160 and negativity is defined as ANA titer less than (<) 1:160. For anti-ds DNA, positivity is defined as any participants with adsDNA > 15 units per milliliter (U/mL), intermediate category is defined as value between 10 U/mL to 15 U/mL and negativity is defined as adsDNA < 10 U/mL.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set was used.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 221 220
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with Negative ANA values
205
  92.8%
190
  86.4%
Participants with Positive ANA values
6
   2.7%
10
   4.5%
Participants with Negative anti-ds DNA values
201
  91.0%
186
  84.5%
Participants with Intermediate anti-ds DNA values
4
   1.8%
5
   2.3%
Participants with Positive anti-ds DNA values
4
   1.8%
6
   2.7%
20.Secondary Outcome
Title Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52
Hide Description Number of participants ANA and anti-ds DNA values were reported. For ANA, positivity is defined as any participants with ANA titer greater than (>) 1:160 and negativity is defined as ANA titer less than (<) 1:160. For anti-ds DNA, positivity is defined as any participants with adsDNA > 15 units per milliliter (U/mL), intermediate category is defined as value between 10 U/mL to 15 U/mL and negativity is defined as adsDNA < 10 U/mL.
Time Frame Week 24, 32, 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ETP-SAF included all re-randomized participants who received at least 1 dose of MSB11022 or EU-approved Humira in ETP. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure & "Number analyzed" signifies those participants who were evaluable for this outcome measure for specified categories.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 213 101 101
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24: Negative ANA Number Analyzed 201 participants 94 participants 97 participants
188
  93.5%
89
  94.7%
92
  94.8%
Week 32: Negative ANA Number Analyzed 199 participants 88 participants 95 participants
186
  93.5%
85
  96.6%
88
  92.6%
Week 40: Negative ANA Number Analyzed 196 participants 91 participants 92 participants
178
  90.8%
85
  93.4%
85
  92.4%
Week 52: Negative ANA Number Analyzed 193 participants 87 participants 87 participants
185
  95.9%
84
  96.6%
79
  90.8%
Week 24: Positive ANA Number Analyzed 201 participants 94 participants 97 participants
13
   6.5%
5
   5.3%
5
   5.2%
Week 32: Positive ANA Number Analyzed 199 participants 88 participants 95 participants
13
   6.5%
3
   3.4%
7
   7.4%
Week 40: Positive ANA Number Analyzed 196 participants 91 participants 92 participants
18
   9.2%
6
   6.6%
7
   7.6%
Week 52: Positive ANA Number Analyzed 193 participants 87 participants 87 participants
8
   4.1%
3
   3.4%
8
   9.2%
Week 24: Negative anti-dsDNA Number Analyzed 202 participants 95 participants 94 participants
191
  94.6%
89
  93.7%
88
  93.6%
Week 32: Negative anti-dsDNA Number Analyzed 199 participants 88 participants 93 participants
184
  92.5%
83
  94.3%
86
  92.5%
Week 40: Negative anti-dsDNA Number Analyzed 196 participants 91 participants 92 participants
179
  91.3%
86
  94.5%
84
  91.3%
Week 52: Negative anti-dsDNA Number Analyzed 192 participants 87 participants 88 participants
173
  90.1%
81
  93.1%
79
  89.8%
Week 24: Positive anti-dsDNA Number Analyzed 202 participants 95 participants 94 participants
8
   4.0%
3
   3.2%
5
   5.3%
Week 32: Positive anti-dsDNA Number Analyzed 199 participants 88 participants 93 participants
8
   4.0%
3
   3.4%
5
   5.4%
Week 40: Positive anti-dsDNA Number Analyzed 196 participants 91 participants 92 participants
10
   5.1%
3
   3.3%
7
   7.6%
Week 52: Positive anti-dsDNA Number Analyzed 192 participants 87 participants 88 participants
11
   5.7%
2
   2.3%
7
   8.0%
Week 24: Intermediate anti-dsDNA Number Analyzed 202 participants 95 participants 94 participants
3
   1.5%
3
   3.2%
1
   1.1%
Week 32: Intermediate anti-dsDNA Number Analyzed 199 participants 88 participants 93 participants
7
   3.5%
2
   2.3%
2
   2.2%
Week 40: Intermediate anti-dsDNA Number Analyzed 196 participants 91 participants 92 participants
7
   3.6%
2
   2.2%
1
   1.1%
Week 52: Intermediate anti-dsDNA Number Analyzed 192 participants 87 participants 88 participants
8
   4.2%
4
   4.6%
2
   2.3%
21.Secondary Outcome
Title Number of Participants With Clinically Meaningful Differences in Vital Signs
Hide Description Number of participants with clinically meaningful abnormalities in vital signs were reported. Clinical meaningful was determined by the investigator.
Time Frame Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set was used for Core Treatment Period. ETP-SAF was used for Extended Treatment Period.
Arm/Group Title MSB11022 (Core Treatment Period) MSB11022 (Extended Treatment Period) EU-Humira EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 221 213 220 101 101
Measure Type: Count of Participants
Unit of Measure: Participants
Vital signs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
22.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG)
Hide Description Number of participants with clinically significant abnormalities in 12-ECG were reported. Clinical significance was determined by the investigator.
Time Frame Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set was used for Core Treatment Period. ETP-SAF was used for Extended Treatment Period.
Arm/Group Title MSB11022 (Core Treatment Period) MSB11022 (Extended Treatment Period) EU-Humira EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 221 213 220 101 101
Measure Type: Count of Participants
Unit of Measure: Participants
12-ECG
0
   0.0%
1
   0.5%
0
   0.0%
1
   1.0%
1
   1.0%
23.Secondary Outcome
Title Dermatology Life Quality Index (DLQI) at Week 16
Hide Description The DLQI is a 10-item validated quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI measures how much participant's skin problems has affected his life. Responses range from 0=Not at all to 3=Very much. The DLQI total score is the sum of individual 10 items and could range from 0 to 30 (higher score indicated greater negative impact on life).
Time Frame Weeks 16
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis set was used.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 203 191
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.4  (3.2) 2.5  (3.7)
24.Secondary Outcome
Title Dermatology Life Quality Index (DLQI) at Week 24 and 52
Hide Description The DLQI is a 10-item validated quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI measures how much participant's skin problems has affected his life. Responses range from 0=Not at all to 3=Very much. The DLQI total score is the sum of individual 10 items and could range from 0 to 30 (higher score indicated greater negative impact on life).
Time Frame Week 24 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ETP-PP analysis set was used. Here "Number analyzed" signifies number of participants who were evaluable for this outcome measure at specified category.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 203 95 96
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 24 Number Analyzed 200 participants 94 participants 92 participants
2.5  (4.1) 2.3  (4.0) 2.3  (3.9)
Week 52 Number Analyzed 186 participants 85 participants 86 participants
3.0  (4.7) 2.1  (3.5) 2.7  (4.0)
25.Secondary Outcome
Title European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 16
Hide Description The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The responses are converted into a single index value, with scores ranging from -0.594 to 1 (a higher score indicates better health state).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis set was used. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 189 179
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.9  (0.1) 0.9  (0.1)
26.Secondary Outcome
Title European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52
Hide Description The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The responses are converted into a single index value, with scores ranging from -0.594 to 1 (a higher score indicates better health state).
Time Frame Week 24 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ETP-PP analysis set was used. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 203 95 96
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 24 Number Analyzed 200 participants 94 participants 92 participants
0.8  (0.1) 0.9  (0.1) 0.9  (0.1)
Week 52 Number Analyzed 186 participants 85 participants 86 participants
0.9  (0.1) 0.9  (0.1) 0.8  (0.1)
27.Secondary Outcome
Title European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on Visual Analogue Scale (VAS) Score at Week 16
Hide Description The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level on a visual analog scale, where the participant was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis set was used. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 189 179
Mean (Standard Deviation)
Unit of Measure: Units on a scale
81.9  (13.9) 83.1  (15.0)
28.Secondary Outcome
Title European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52
Hide Description The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level on a visual analog scale, where the participant was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state.
Time Frame Week 24 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ETP-PP analysis set was used. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 203 95 96
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 24 Number Analyzed 200 participants 94 participants 92 participants
83.2  (14.2) 84.2  (13.7) 84.3  (13.9)
Week 52 Number Analyzed 186 participants 85 participants 86 participants
83.5  (15.5) 85.1  (13.2) 82.1  (16.1)
29.Secondary Outcome
Title Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 16
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis set was used. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.3  (0.4) 0.3  (0.4)
30.Secondary Outcome
Title Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame Week 24 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ETP-PP analysis set was used. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 203 95 96
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 24 Number Analyzed 18 participants 8 participants 10 participants
0.3  (0.4) 0.2  (0.5) 0.4  (0.3)
Week 52 Number Analyzed 18 participants 7 participants 10 participants
0.3  (0.4) 0.1  (0.2) 0.5  (0.3)
31.Secondary Outcome
Title Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 16
Hide Description Patient global assessment for joints was measured on a 100 millimeter (mm) VAS scale, where 0 = no pain and 100 = worst possible pain.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis set was used. Here "Number of participants analyzed" signifies participants who were evaluable for this outcome measure at specified category.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
26.9  (28.3) 24.6  (24.3)
32.Secondary Outcome
Title Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52
Hide Description Patient global assessment for joints was measured on a 100 millimeter (mm) VAS scale, where 0 = no pain and 100 = worst possible pain.
Time Frame Week 24 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ETP-PP analysis set was used. Here "Number analyzed" signifies participants who were evaluable for this outcome measure at specified category.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 203 95 96
Mean (Standard Deviation)
Unit of Measure: mm
Week 24 Number Analyzed 18 participants 8 participants 10 participants
29.7  (25.3) 20.6  (27.1) 24.9  (20.5)
Week 52 Number Analyzed 18 participants 7 participants 10 participants
25.0  (20.3) 14.7  (16.5) 29.5  (19.6)
33.Secondary Outcome
Title Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16
Hide Description Number of participants with treatment emergent Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab were reported from baseline to week 16. Data was collected using validated bioanalytical method.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set was used. Here "Number of participants analyzed" signifies those who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 213 202
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with ADAs Number Analyzed 213 participants 202 participants
186
  87.3%
179
  88.6%
Participants with Neutralizing Abs Number Analyzed 186 participants 179 participants
70
  37.6%
70
  39.1%
34.Secondary Outcome
Title Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52
Hide Description Number of participants With positive treatment emergent Anti-Drug Antibodies (ADAs) and positive Neutralizing Antibodies (NAbs) to Adalimumab were reported. Data was collected using validated bioanalytical method.
Time Frame Week 24, 32, 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ETP-SAF analysis set was used. Here "Number analyzed" signifies participants who were evaluable for this outcome measure at specified category.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 213 101 101
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24: ADAs Number Analyzed 208 participants 96 participants 97 participants
185
  88.9%
89
  92.7%
90
  92.8%
Week 32: ADAs Number Analyzed 200 participants 90 participants 96 participants
170
  85.0%
78
  86.7%
85
  88.5%
Week 40: ADAs Number Analyzed 197 participants 89 participants 92 participants
161
  81.7%
72
  80.9%
80
  87.0%
Week 52: ADAs Number Analyzed 194 participants 87 participants 87 participants
162
  83.5%
68
  78.2%
77
  88.5%
Week 24: NAb Number Analyzed 185 participants 89 participants 90 participants
78
  42.2%
42
  47.2%
39
  43.3%
Week 32: NAb Number Analyzed 170 participants 78 participants 85 participants
67
  39.4%
30
  38.5%
32
  37.6%
Week 40: NAb Number Analyzed 160 participants 72 participants 80 participants
70
  43.8%
29
  40.3%
28
  35.0%
Week 52: NAb Number Analyzed 162 participants 68 participants 77 participants
63
  38.9%
29
  42.6%
30
  39.0%
35.Secondary Outcome
Title Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 16
Hide Description Anti-Drug Antibodies (ADAs) Titers for adalimumab at week 16 was reported. Data was collected using validated bioanalytical method.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set was used. Here "Number of Participants analyzed" signifies those who were evaluable for this outcome measure.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 213 202
Median (Full Range)
Unit of Measure: Titers
8.0
(1 to 2048)
8.0
(1 to 1024)
36.Secondary Outcome
Title Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52
Hide Description Anti-Drug Antibodies (ADAs) Titers for adalimumab at Week 24, 32, 40 and 50 was reported. Data was collected using validated bioanalytical method.
Time Frame Week 24, 32, 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ETP-SAF analysis set was used. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 213 101 101
Median (Full Range)
Unit of Measure: Titers
Week 24 Number Analyzed 185 participants 89 participants 90 participants
16.0
(1 to 4096)
16.0
(1 to 4096)
16.0
(1 to 4096)
Week 32 Number Analyzed 170 participants 78 participants 85 participants
16.0
(1 to 1024)
16.0
(1 to 8192)
16.0
(1 to 16384)
Week 40 Number Analyzed 161 participants 72 participants 80 participants
16.0
(1 to 8192)
16.0
(1 to 8192)
16.0
(1 to 16384)
Week 52 Number Analyzed 162 participants 68 participants 77 participants
8.0
(1 to 4096)
16.0
(1 to 4096)
8.0
(1 to 4096)
37.Secondary Outcome
Title Observed Serum Concentration at Week 16
Hide Description Observed serum concentrations at week 16 were reported.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) Analysis Set included all participants in the SAF who also had at least 1 measurable post-dose concentration. Here "Number of Participants analyzed" signifies those who were evaluable for this outcome measure.
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira
Hide Arm/Group Description:
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
Overall Number of Participants Analyzed 192 170
Geometric Mean (Standard Deviation)
Unit of Measure: Nanogram per milliliter (ng/mL)
6990  (4504) 6410  (4152)
38.Secondary Outcome
Title Observed Serum Concentration at Week 24 and 52
Hide Description Observed serum concentrations at week 24 and 52 were reported.
Time Frame Week 24 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The ETP-PK analysis included all participants in ETP SAF who had at least 1 measurable post-dose concentration in ETP, without any important protocol deviations that could have impacted quality of PK data during ETP. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.
Arm/Group Title MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description:
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Overall Number of Participants Analyzed 198 87 92
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 24 Number Analyzed 184 participants 86 participants 85 participants
6240  (4569) 5870  (4516) 6430  (4610)
Week 52 Number Analyzed 161 participants 76 participants 72 participants
6910  (5750) 5930  (4529) 6600  (5394)
Time Frame Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MSB11022 (Core Treatment Period) EU-Humira MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Hide Arm/Group Description Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period. Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period. Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period. Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period. Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
All-Cause Mortality
MSB11022 (Core Treatment Period) EU-Humira MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/221 (0.00%)      0/220 (0.00%)      0/213 (0.00%)      1/101 (0.99%)      0/101 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
MSB11022 (Core Treatment Period) EU-Humira MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/221 (3.62%)      6/220 (2.73%)      12/213 (5.63%)      3/101 (2.97%)      4/101 (3.96%)    
Blood and lymphatic system disorders           
Neutropenia  1  0/221 (0.00%)  0 1/220 (0.45%)  1 0/213 (0.00%)  0 0/101 (0.00%)  0 0/101 (0.00%)  0
Cardiac disorders           
Acute myocardial infarction  1  0/221 (0.00%)  0 0/220 (0.00%)  0 1/213 (0.47%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Atrial Fibrillation  1  1/221 (0.45%)  1 0/220 (0.00%)  0 1/213 (0.47%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Cardiac failure  1  0/221 (0.00%)  0 0/220 (0.00%)  0 0/213 (0.00%)  0 2/101 (1.98%)  2 0/101 (0.00%)  0
Cardiomyopathy  1  0/221 (0.00%)  0 0/220 (0.00%)  0 1/213 (0.47%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Coronary artery stenosis  1  0/221 (0.00%)  0 0/220 (0.00%)  0 1/213 (0.47%)  2 0/101 (0.00%)  0 0/101 (0.00%)  0
Hypertensive cardiomyopathy  1  0/221 (0.00%)  0 0/220 (0.00%)  0 0/213 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Mitral valve incompetence  1  0/221 (0.00%)  0 0/220 (0.00%)  0 0/213 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Myocardial infarction  1  0/221 (0.00%)  0 0/220 (0.00%)  0 0/213 (0.00%)  0 0/101 (0.00%)  0 1/101 (0.99%)  1
Eye disorders           
Conjunctival cyst  1  0/221 (0.00%)  0 0/220 (0.00%)  0 0/213 (0.00%)  0 0/101 (0.00%)  0 1/101 (0.99%)  1
Gastrointestinal disorders           
Inguinal hernia  1  0/221 (0.00%)  0 0/220 (0.00%)  0 1/213 (0.47%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
General disorders           
Hernia  1  1/221 (0.45%)  1 0/220 (0.00%)  0 0/213 (0.00%)  0 0/101 (0.00%)  0 0/101 (0.00%)  0
Hepatobiliary disorders           
Cholecystitis chronic  1  1/221 (0.45%)  1 0/220 (0.00%)  0 0/213 (0.00%)  0 0/101 (0.00%)  0 0/101 (0.00%)  0
Immune system disorders           
Anaphylactic shock  1  0/221 (0.00%)  0 1/220 (0.45%)  1 0/213 (0.00%)  0 0/101 (0.00%)  0 0/101 (0.00%)  0
Infections and infestations           
Appendicitis  1  0/221 (0.00%)  0 0/220 (0.00%)  0 0/213 (0.00%)  0 0/101 (0.00%)  0 1/101 (0.99%)  1
Arthritis bacterial  1  0/221 (0.00%)  0 1/220 (0.45%)  1 0/213 (0.00%)  0 0/101 (0.00%)  0 0/101 (0.00%)  0
Peritonsillar abscess  1  0/221 (0.00%)  0 0/220 (0.00%)  0 1/213 (0.47%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Pneumonia  1  0/221 (0.00%)  0 0/220 (0.00%)  0 0/213 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Respiratory tract infection viral  1  1/221 (0.45%)  1 0/220 (0.00%)  0 0/213 (0.00%)  0 0/101 (0.00%)  0 0/101 (0.00%)  0
Sinusitis  1  0/221 (0.00%)  0 0/220 (0.00%)  0 1/213 (0.47%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Staphylococcal abscess  1  0/221 (0.00%)  0 0/220 (0.00%)  0 0/213 (0.00%)  0 0/101 (0.00%)  0 1/101 (0.99%)  1
Injury, poisoning and procedural complications           
Accidental overdose  1  0/221 (0.00%)  0 0/220 (0.00%)  0 1/213 (0.47%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Ankle fracture  1  1/221 (0.45%)  1 0/220 (0.00%)  0 0/213 (0.00%)  0 0/101 (0.00%)  0 0/101 (0.00%)  0
Facial bones fracture  1  0/221 (0.00%)  0 0/220 (0.00%)  0 1/213 (0.47%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Ligament sprain  1  0/221 (0.00%)  0 0/220 (0.00%)  0 1/213 (0.47%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Investigations           
Hepatic enzyme increased  1  0/221 (0.00%)  0 1/220 (0.45%)  1 0/213 (0.00%)  0 0/101 (0.00%)  0 0/101 (0.00%)  0
Liver function test increased  1  0/221 (0.00%)  0 1/220 (0.45%)  1 0/213 (0.00%)  0 0/101 (0.00%)  0 0/101 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Intervertebral disc protrusion  1  0/221 (0.00%)  0 0/220 (0.00%)  0 1/213 (0.47%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Osteoarthritis  1  0/221 (0.00%)  0 0/220 (0.00%)  0 1/213 (0.47%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Osteonecrosis  1  1/221 (0.45%)  1 0/220 (0.00%)  0 0/213 (0.00%)  0 0/101 (0.00%)  0 0/101 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Intraductal proliferative breast lesion  1  0/221 (0.00%)  0 1/220 (0.45%)  1 0/213 (0.00%)  0 0/101 (0.00%)  0 0/101 (0.00%)  0
Nervous system disorders           
Brain oedema  1  0/221 (0.00%)  0 0/220 (0.00%)  0 0/213 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Cerebral haematoma  1  0/221 (0.00%)  0 0/220 (0.00%)  0 0/213 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Renal and urinary disorders           
Acute kidney injury  1  0/221 (0.00%)  0 0/220 (0.00%)  0 1/213 (0.47%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Skin and subcutaneous tissue disorders           
Erythema multiforme  1  1/221 (0.45%)  1 0/220 (0.00%)  0 0/213 (0.00%)  0 0/101 (0.00%)  0 0/101 (0.00%)  0
Hypersensitivity vasculitis  1  0/221 (0.00%)  0 0/220 (0.00%)  0 1/213 (0.47%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Vascular disorders           
Hypertension  1  1/221 (0.45%)  1 0/220 (0.00%)  0 0/213 (0.00%)  0 0/101 (0.00%)  0 0/101 (0.00%)  0
Vascular compression  1  0/221 (0.00%)  0 0/220 (0.00%)  0 1/213 (0.47%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MSB11022 (Core Treatment Period) EU-Humira MSB11022 (Extended Treatment Period) EU-Humira/EU-Humira EU-Humira/MSB11022
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/221 (13.57%)      34/220 (15.45%)      59/213 (27.70%)      32/101 (31.68%)      25/101 (24.75%)    
General disorders           
Injection site erythema  1  11/221 (4.98%)  18 13/220 (5.91%)  19 9/213 (4.23%)  19 5/101 (4.95%)  25 6/101 (5.94%)  31
Injection site pain  1  11/221 (4.98%)  52 11/220 (5.00%)  28 12/213 (5.63%)  54 4/101 (3.96%)  4 5/101 (4.95%)  18
Infections and infestations           
Nasopharyngitis  1  13/221 (5.88%)  13 15/220 (6.82%)  16 31/213 (14.55%)  36 12/101 (11.88%)  14 16/101 (15.84%)  16
Upper respiratory tract infection  1  0/221 (0.00%)  0 0/220 (0.00%)  0 11/213 (5.16%)  15 5/101 (4.95%)  7 4/101 (3.96%)  4
Skin and subcutaneous tissue disorders           
Psoriasis  1  0/221 (0.00%)  0 0/220 (0.00%)  0 11/213 (5.16%)  12 10/101 (9.90%)  11 3/101 (2.97%)  3
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Communication Center
Organization: Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
EMail: service@emdgroup.com
Layout table for additonal information
Responsible Party: Fresenius Kabi SwissBioSim GmbH
ClinicalTrials.gov Identifier: NCT02660580     History of Changes
Other Study ID Numbers: EMR200588-002
2015-003287-37 ( EudraCT Number )
First Submitted: January 17, 2016
First Posted: January 21, 2016
Results First Submitted: January 2, 2019
Results First Posted: February 19, 2019
Last Update Posted: July 1, 2019