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| ID | Type | Description | Link |
|---|---|---|---|
| MK-2155-139 | Other Identifier | Merck Study Number |
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This is a prospective Phase 4, open-label, non-randomized, observational, multi-center study of infliximab in participants with plaque-type psoriasis to assess the clinical response in real-world practice of long-term maintenance therapy with infliximab 5 mg/kg body weight in a psoriasis population, prescribed in a regimen in accordance with the product monograph (PM) for Canada, the approved summary sheet of product characteristics (SPC) for countries in the European Union (EU), or per label according to local guidelines for all other participating countries.
This study will be conducted in two phases: the 50-week treatment period and the 48-week extended treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab 5 mg/kg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Biological | Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50 | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline. | Week 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14 | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 response was defined as >= 90% improvement when compared to baseline. |
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Inclusion Criteria:
Exclusion Criteria:
For the Treatment Period
For the Extended Treatment Period
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Participants with plaque-type psoriasis in which the treating physician has selected for treatment with infliximab, in accordance with local clinical practices, will be advised about this trial. It is highly recommended that 30% of the participants enrolled be naïve to previous biologic therapy. For example, if a site recruits 10 participants, 3 out of these 10 participants should be naïve to previous biologic therapy.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24673357 | Result | Shear NH, Hartmann M, Toledo-Bahena M, Katsambas A, Connors L, Chang Q, Yao R, Nograles K, Popmihajlov Z; REALITY investigators. Long-term efficacy and safety of infliximab maintenance therapy in patients with plaque-type psoriasis in real-world practice. Br J Dermatol. 2014 Sep;171(3):631-41. doi: 10.1111/bjd.13004. Epub 2014 Aug 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Infliximab 5 mg/kg | Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
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| ||||||||||||||||||||||||
| Extended Treatment Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Infliximab 5 mg/kg | Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50 | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline. | The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score. | Posted | Number | Participants | Week 50 |
Up to Week 98
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infliximab 5 mg/kg | Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Week 50 |
| Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14 | Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined as >=90% improvement and a >=75% improvement, respectively, in overall PASI score when compared to baseline. | Week 50 |
| Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14 | Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline. | Week 50 |
| Number of Participants With a PASI-90 Response at Week 98 Among Participants With a PASI-90 Response at Week 50 and Who Entered the Extended Treatment Period | Participant PSAI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4=very severe, each body region (head, trunk, arms, and legs) is rate for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each regon represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, legs=0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multipled by the subtotal of the body area of that region; the four region scores are then added to produce the total PASI score. PSAI-90 response was defined as >=90% improvement in overall PASI score when compared to baseline. | Week 98 |
| Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period | Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline, respectively. | Week 98 |
| Change From Baseline in Mean PASI Score | Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. Decreasing scores are indicative of improvement in overall PASI score. | Baseline, Week 14, Week 30, Week 50, Week 62, Week 78, Week 98 |
| Number of Participants With a PASI-90 or PASI-75 Response at Week 98 Among Participants Who Had a PASI-75 Response at Week 50 and Who Entered the Extended Treatment Phase | PASI socres were used to measure the severity and extent of psoriasis. Using a scale of 0=nonoe to 4=very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region; thse 4 totals (ranging from 0 to 16) are then multipled by the standardized percentage of total body area that region represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, and legs=0.4 of body surface area). An assessment is then made of the percentage of area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined at >=90% and >=75% improvement in overall PASI score when compared to baselne, respectively. | Week 98 |
| Change From Baseline in Mean Dermatology Life Quality Index (DLQI) | The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life. | Baseline, Week 50, Week 62, Week 78, Week 98 |
| Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life. | Week 50, Week 62, Week 78, Week 98 |
| Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98 | Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, PASI-90, and PASI-100 response were defined as >=25%, >=50%, >=75%, >=90%, =100% improvement in PASI score versus baseline, respectively. | Week 98 |
| Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline. | Week 50 |
| Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline. | Week 50 |
| Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline. | Week 50 |
| Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline. | Week 50 |
| Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.. | Week 50 |
| Lost to Follow-up |
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| Withdrawal by Subject |
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| Protocol Violation |
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| Did Not Meet Protocol Eligibility |
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| Administrative |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Infliximab 5 mg/kg | Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries). |
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| Secondary | Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14 | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 response was defined as >= 90% improvement when compared to baseline. | The population consists of all participants that achieved a PASI-90 response at treatment Week 14. | Posted | Number | Participants | Week 50 |
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| Secondary | Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14 | Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined as >=90% improvement and a >=75% improvement, respectively, in overall PASI score when compared to baseline. | The population consists of all participants that achieved PASI-75 response by treatment Week 14. | Posted | Number | Participants | Week 50 |
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| Secondary | Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14 | Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline. | The population includes all participants that achieved a PASI-50 response at treatment Week 14. | Posted | Number | Participants | Week 50 |
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| Secondary | Number of Participants With a PASI-90 Response at Week 98 Among Participants With a PASI-90 Response at Week 50 and Who Entered the Extended Treatment Period | Participant PSAI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4=very severe, each body region (head, trunk, arms, and legs) is rate for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each regon represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, legs=0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multipled by the subtotal of the body area of that region; the four region scores are then added to produce the total PASI score. PSAI-90 response was defined as >=90% improvement in overall PASI score when compared to baseline. | The population consists of all participants that achieved PASI-90 response at Week 50 and entered the extended treatment phase. | Posted | Number | Participants | Week 98 |
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| Secondary | Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period | Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline, respectively. | The population includes all participants that achieved PASI-50 response at Week 50 and entered the extended treatment phase. | Posted | Number | Participants | Week 98 |
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| Secondary | Change From Baseline in Mean PASI Score | Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. Decreasing scores are indicative of improvement in overall PASI score. | The population consists of all participants with a baseline PASI score and a subsequent score at Week 14, 30, 50, 62, 78,and 98. | Posted | Mean | 95% Confidence Interval | Score on a Scale | Baseline, Week 14, Week 30, Week 50, Week 62, Week 78, Week 98 |
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| Secondary | Number of Participants With a PASI-90 or PASI-75 Response at Week 98 Among Participants Who Had a PASI-75 Response at Week 50 and Who Entered the Extended Treatment Phase | PASI socres were used to measure the severity and extent of psoriasis. Using a scale of 0=nonoe to 4=very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region; thse 4 totals (ranging from 0 to 16) are then multipled by the standardized percentage of total body area that region represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, and legs=0.4 of body surface area). An assessment is then made of the percentage of area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined at >=90% and >=75% improvement in overall PASI score when compared to baselne, respectively. | The population consisted of participants who were in the efficacy population of the treatment phase and who entered into the extended treatment phase and had a PASI-75 response at Week 50 with at least one PASI evaluation during the extended treatment phase. | Posted | Number | Participants | Week 98 |
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| Secondary | Change From Baseline in Mean Dermatology Life Quality Index (DLQI) | The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life. | The population consisted of all participants with a DLQI measurement at baseline and at each time point. | Posted | Mean | Standard Error | Score on a Scale | Baseline, Week 50, Week 62, Week 78, Week 98 |
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| Secondary | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life. | The population consisted of all participants with a DLQI measurement at each time point. | Posted | Number | Participants | Week 50, Week 62, Week 78, Week 98 |
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| Secondary | Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98 | Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, PASI-90, and PASI-100 response were defined as >=25%, >=50%, >=75%, >=90%, =100% improvement in PASI score versus baseline, respectively. | The population consisted of participants who were in the efficacy population of the treatment phase and who entered into the extended treatment phase with at least one PASI evaluation during the extended treatment phase. | Posted | Number | Participants | Week 98 |
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|
|
| Secondary | Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline. | The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score. | Posted | Number | Participants | Week 50 |
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| Secondary | Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline. | The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score. | Posted | Number | Participants | Week 50 |
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| Secondary | Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline. | The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score. | Posted | Number | Participants | Week 50 |
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| Secondary | Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline. | The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score. | Posted | Number | Participants | Week 50 |
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| Secondary | Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.. | The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score. | Posted | Number | Participants | Week 50 |
|
|
|
| 56 |
| 659 |
| 0 |
| 659 |
| Microcytic Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cardiopulmonary Failure | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Coronary Artery Stenosis | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Left Ventricular Failure | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Thyroiditis | Endocrine disorders | MedDRA (16.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Gastrointestinal Disorder | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Drug Interaction | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cytolytic Hepatitis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Gallbladder Polyp | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Anaphylactic Reaction | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Clostridial Infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Enterocolitis Infectious | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Gastroenteritis Salmonella | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Lymph Node Tuberculosis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Hepatic Enzyme Increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Tuberculin Test Positive | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Psoriatic Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
|
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
|
| Malignant Peritoneal Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
|
| Basal Ganglia Haemorrhage | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Intraventricular Haemorrhage | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Ischaemic Stroke | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Myoclonus | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (16.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Enuresis | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Renal Colic | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
|
| Lung Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Acute Generalised Exanthematous Pustulosis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Erythrodermic Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pregnancy of Partner | Social circumstances | MedDRA (16.0) | Systematic Assessment |
|
| Inguinal Hernia Repair | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
|
| Umbilical Hernia Repair | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
|
| Aortic Aneurysm | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Umbilical Hernia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Liver Function Test Abnormal | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
|
| Bladder Tamponade | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
|
| Erythema Multiforme | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hip Arthroplasty | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
|
The investigator agrees to provide the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data.
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
|
| Week 62 (n=136) |
|
| Week 78 (n=143) |
|
| Week 98 (n=142) |
|
|
| Week 98 (n=140) |
|
| Title | Measurements |
|---|---|
|
| Week 50, DLQI Missing |
|
| Week 62, DLQI=0 |
|
| Week 62, DLQI=0 or 1 |
|
| Week 62, DLQI >1 |
|
| Week 62, DLQI Missing |
|
| Week 78, DLQI=0 |
|
| Week 78, DLQI=0 or 1 |
|
| Week 78, DLQI >1 |
|
| Week 78, DLQI Missing |
|
| Week 98, DLQI=0 |
|
| Week 98. DLQI=0 or 1 |
|
| Week 98, DLQI >1 |
|
| Week 98, DLQI Missing |
|
| Title | Measurements |
|---|
|
| PASI-100 |
|