Psoriasis
Conditions
Keywords
Moderate to Severe Plaque-Type Psoriasis, Psoriasis, Plaque-type psoriasis, CNTO 1959, adalimumab
Brief summary
The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the treatment of patients with moderate to severe plaque psoriasis.
Detailed description
This is a multicenter, dose-ranging study of CNTO 1959 in patients with moderate to severe plaque psoriasis. Patients who satisfy all inclusion and exclusion criteria will be assigned by chance to one of 7 treatment groups: a placebo group (a placebo is a treatment identical in appearance to CNTO 1959 but does not contain active drug), 1 of 5 dose groups for CNTO 1959, or adalimumab. Patients assigned to adalimumab will be dosed according to the labeled dosing for psoriasis. At Week 16, patients initially assigned to placebo will begin receiving CNTO 1959. Patients initially assigned to CNTO 1959 will continue to receive the same assigned dose level of study agent from Week 16 through Week 40. Patients receiving adalimumab will continue the labeled dosing regimen. All patients will be reassessed for clinical response every 4 weeks from Week 4 through Week 40. Patients will continue dosing through Week 40, with a subsequent efficacy and safety follow-up visit at Week 52. Patient safety will be monitored throughout the study.
Interventions
DRUGCNTO 1959 (100 mg)
SC injections
DRUGCNTO 1959 (200 mg)
SC injections
DRUGAdalimumab
SC injections
DRUGPlacebo
SC injections
DRUGCNTO 1959 (5 mg)
Subcutaneous (SC) injections
DRUGCNTO 1959 (15 mg)
SC injections
DRUGCNTO 1959 (50 mg)
SC injections
Sponsors
Janssen Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent * Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment) * Must be considered, in the opinion of the investigator, suitable candidates for adalimumab therapy * If a woman, she must be postmenopausal, or if premenopausal, she must be either surgically sterile, practicing a highly effective method of birth control, or not heterosexually active during the study and for 5 months after receiving the last dose of study drug * If a man, he must agree to use a double-barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study and for 5 months after receiving the last dose of study drug.
Exclusion criteria
* History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease * Has a contra-indication to anti-TNF therapy * Has a history of chronic or recurrent infectious disease * Has a nonplaque form of psoriasis or has drug-induced psoriasis * Has been previously treated with adalimumab * Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23, (including but not limited to ustekinumab, briakinumab \[ABT-874\], AIN457, and SCH900222) within 6 months of the first administration of study agent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 | Week 16 | PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema \[0 (no evidence of plaque) to 5 (dusky to deep red coloration)\], induration \[0 (no plaque evaluation) to 5 (marked plaque evaluation)\] and scaling \[0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)\]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 | Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. |
| Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16 | Week 16 | PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema \[0 (no evidence of plaque) to 5 (dusky to deep red coloration)\], induration \[0 (no plaque evaluation) to 5 (marked plaque evaluation)\] and scaling \[0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)\]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe). |
| Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40 | Week 40 | PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema \[0 (no evidence of plaque) to 5 (dusky to deep red coloration)\], induration \[0 (no plaque evaluation) to 5 (marked plaque evaluation)\] and scaling \[0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)\]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe). |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 | Baseline and Week 16 | The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. |
Countries
Belgium, Canada, Germany, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40. | 42 |
| CNTO1959 5 mg Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40. | 41 |
| CNTO1959 15 mg Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40. | 41 |
| CNTO1959 50 mg Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40. | 42 |
| CNTO1959 100 mg Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40. | 42 |
| CNTO1959 200 mg Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40. | 42 |
| Adalimumab Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39. | 43 |
| Total | 293 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| After Controlled Period(Week 16-Week 40) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 1 |
| After Controlled Period(Week 16-Week 40) | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| After Controlled Period(Week 16-Week 40) | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 1 | 4 |
| After Controlled Period(Week 16-Week 40) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 |
| After Controlled Period(Week 16-Week 40) | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 4 | 0 | 0 | 1 | 0 |
| After Controlled Period(Week 16-Week 40) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 1 |
| Controlled Period (CP) (up to Week 16) | Adverse Event | 2 | 0 | 0 | 1 | 1 | 4 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Controlled Period (CP) (up to Week 16) | Lack of Efficacy | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Controlled Period (CP) (up to Week 16) | Lost to Follow-up | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Controlled Period (CP) (up to Week 16) | Other | 0 | 2 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | CNTO1959 5 mg | CNTO1959 15 mg | CNTO1959 50 mg | CNTO1959 100 mg | Placebo | CNTO1959 200 mg | Adalimumab | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants | 6 Participants | 1 Participants | 2 Participants | 8 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 39 Participants | 41 Participants | 36 Participants | 41 Participants | 40 Participants | 35 Participants | 271 Participants |
| Age, Continuous | 45.2 years STANDARD_DEVIATION 13.92 | 43.8 years STANDARD_DEVIATION 13.5 | 42.6 years STANDARD_DEVIATION 12.14 | 45.3 years STANDARD_DEVIATION 13.72 | 45 years STANDARD_DEVIATION 11.97 | 45.1 years STANDARD_DEVIATION 10.96 | 47.5 years STANDARD_DEVIATION 14.91 | 44.9 years STANDARD_DEVIATION 13.02 |
| Region of Enrollment Belgium | 1 participants | 0 participants | 0 participants | 1 participants | 2 participants | 1 participants | 0 participants | 5 participants |
| Region of Enrollment Canada | 11 participants | 11 participants | 11 participants | 12 participants | 13 participants | 14 participants | 11 participants | 83 participants |
| Region of Enrollment Germany | 2 participants | 4 participants | 5 participants | 4 participants | 2 participants | 3 participants | 3 participants | 23 participants |
| Region of Enrollment Poland | 8 participants | 7 participants | 10 participants | 7 participants | 7 participants | 8 participants | 8 participants | 55 participants |
| Region of Enrollment United States | 19 participants | 19 participants | 16 participants | 18 participants | 18 participants | 16 participants | 21 participants | 127 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 12 Participants | 10 Participants | 14 Participants | 11 Participants | 13 Participants | 86 Participants |
| Sex: Female, Male Male | 28 Participants | 28 Participants | 30 Participants | 32 Participants | 28 Participants | 31 Participants | 30 Participants | 207 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 42 | 15 / 41 | 10 / 41 | 10 / 42 | 7 / 42 | 8 / 41 | 10 / 43 | 16 / 39 | 12 / 38 | 4 / 41 | 11 / 39 | 16 / 40 | 12 / 38 | 13 / 38 |
| serious Total, serious adverse events | 1 / 42 | 0 / 41 | 0 / 41 | 3 / 42 | 0 / 42 | 0 / 41 | 1 / 43 | 0 / 39 | 2 / 38 | 0 / 41 | 0 / 39 | 2 / 40 | 0 / 38 | 1 / 38 |
Outcome results
Primary
Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema \[0 (no evidence of plaque) to 5 (dusky to deep red coloration)\], induration \[0 (no plaque evaluation) to 5 (marked plaque evaluation)\] and scaling \[0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)\]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).
Time frame: Week 16
Population: Population analyzed included all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 | 7.1 percentage of participants |
| CNTO1959 5 mg | Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 | 34.1 percentage of participants |
| CNTO1959 15 mg | Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 | 61.0 percentage of participants |
| CNTO1959 50 mg | Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 | 78.6 percentage of participants |
| CNTO1959 100 mg | Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 | 85.7 percentage of participants |
| CNTO1959 200 mg | Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 | 83.3 percentage of participants |
| Adalimumab | Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 | 58.1 percentage of participants |
Comparison: p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (less than or equal to (\<=) 90 kilogram (kg), greater than (\>) 90 kg).p-value: 0.002Cochran-Mantel-Haenszel chi-square test
Comparison: p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).p-value: <0.001Cochran-Mantel-Haenszel chi-square test
Comparison: p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).p-value: <0.001Cochran-Mantel-Haenszel chi-square test
Comparison: p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).p-value: <0.001Cochran-Mantel-Haenszel chi-square test
Comparison: p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).p-value: <0.001Cochran-Mantel-Haenszel chi-square test
Comparison: p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).p-value: <0.001Cochran-Mantel-Haenszel chi-square test
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Time frame: Baseline and Week 16
Population: Population analyzed included all participants who were randomized. Here, 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 | -2.3 units on a scale | Standard Deviation 6.8 |
| CNTO1959 5 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 | -6.2 units on a scale | Standard Deviation 5.24 |
| CNTO1959 15 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 | -10.3 units on a scale | Standard Deviation 5.49 |
| CNTO1959 50 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 | -11.1 units on a scale | Standard Deviation 7.38 |
| CNTO1959 100 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 | -10.8 units on a scale | Standard Deviation 7.34 |
| CNTO1959 200 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 | -11.4 units on a scale | Standard Deviation 6.83 |
| Adalimumab | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 | -10.1 units on a scale | Standard Deviation 9 |
p-value: 0.008ANOVA on the van Der Waerden score
p-value: <0.001ANOVA on the van Der Waerden score
p-value: <0.001ANOVA on the van Der Waerden score
p-value: <0.001ANOVA on the van Der Waerden score
p-value: <0.001ANOVA on the van Der Waerden score
p-value: <0.001ANOVA on the van Der Waerden score
Secondary
Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema \[0 (no evidence of plaque) to 5 (dusky to deep red coloration)\], induration \[0 (no plaque evaluation) to 5 (marked plaque evaluation)\] and scaling \[0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)\]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).
Time frame: Week 16
Population: Population analyzed included all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16 | 34.1 percentage of participants |
| CNTO1959 5 mg | Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16 | 61.0 percentage of participants |
| CNTO1959 15 mg | Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16 | 78.6 percentage of participants |
| CNTO1959 50 mg | Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16 | 85.7 percentage of participants |
| CNTO1959 100 mg | Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16 | 83.3 percentage of participants |
| CNTO1959 200 mg | Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16 | 58.1 percentage of participants |
Comparison: The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).95% CI: [-44, -4]
Comparison: The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).95% CI: [-17.9, 23.5]
Comparison: The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).95% CI: [1.5, 39.3]
Comparison: The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).95% CI: [9.8, 45.6]
95% CI: [7.2, 43.6]
Secondary
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.
Time frame: Week 16
Population: Population analyzed included all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 | 4.8 percentage of participants |
| CNTO1959 5 mg | Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 | 43.9 percentage of participants |
| CNTO1959 15 mg | Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 | 75.6 percentage of participants |
| CNTO1959 50 mg | Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 | 81.0 percentage of participants |
| CNTO1959 100 mg | Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 | 78.6 percentage of participants |
| CNTO1959 200 mg | Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 | 81.0 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 | 69.8 percentage of participants |
Comparison: p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).p-value: <0.001Cochran-Mantel-Haenszel chi-square test
Comparison: p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).p-value: <0.001Cochran-Mantel-Haenszel chi-square test
Comparison: p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).p-value: <0.001Cochran-Mantel-Haenszel chi-square test
Comparison: p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).p-value: <0.001Cochran-Mantel-Haenszel chi-square test
Comparison: p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).p-value: <0.001Cochran-Mantel-Haenszel chi-square test
Comparison: p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).p-value: <0.001Cochran-Mantel-Haenszel chi-square test
Secondary
Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema \[0 (no evidence of plaque) to 5 (dusky to deep red coloration)\], induration \[0 (no plaque evaluation) to 5 (marked plaque evaluation)\] and scaling \[0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)\]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).
Time frame: Week 40
Population: Population analyzed included all participants who were randomized. Here, 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure. The placebo reporting group was not planned to be analyzed in this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40 | 35.3 percentage of participants |
| CNTO1959 5 mg | Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40 | 59.5 percentage of participants |
| CNTO1959 15 mg | Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40 | 71.1 percentage of participants |
| CNTO1959 50 mg | Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40 | 76.9 percentage of participants |
| CNTO1959 100 mg | Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40 | 81.1 percentage of participants |
| CNTO1959 200 mg | Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40 | 48.6 percentage of participants |
Comparison: The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).95% CI: [-37.7, 6.9]
Comparison: The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).95% CI: [-10.7, 32.4]
Comparison: The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).95% CI: [1.8, 43.6]
Comparison: The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).95% CI: [8.5, 49]
Comparison: The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).95% CI: [13, 52.8]