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The purpose of this study is to compare the safety and efficacy of risankizumab to methotrexate in participants with moderate to severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate | Active Comparator | Participants to receive double-blind methotrexate. |
|
| Risankizumab | Experimental | Participants to receive double-blind risankizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risankizumab | Drug | subcutaneous (SC) injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 28. | The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. | Week 28 |
| Percentage of participants with a ≥ 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 28 | PASI90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part. | Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with a 100% reduction from Baseline PASI score (PASI 100) at Week 28 | PASI100 denotes greater than or equal to 100% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part. | Week 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CETI - Centro de Estudos em Terapias Inovadoras /ID# 208593 | Curitiba | Paraná | 80030-110 | Brazil | ||
| PUC Trials-Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR /ID# 164401 |
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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| methotrexate | Drug | capsule |
|
| Percentage of participants with a ≥ 75% reduction from Baseline PASI score (PASI 75) at Week 28 | PASI75 denotes greater than or equal to 75% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part. | Week 28 |
| Percentage of participants with Static Physician Global Assessment (sPGA) score of clear (0) at Week 28 | The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. | Week 28 |
| Change from baseline in EQ-5D-5L at all visits collected | The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. | Week 28 |
| Achievement of an increase of 0.1 or more points from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) at all visits | The EQ-5D-5L has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a five-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. | Week 28 |
| Curitiba |
| Paraná |
| 80230-130 |
| Brazil |
| Hospital Moinhos de Vento /ID# 208592 | Porto Alegre | Rio Grande do Sul | 90035-001 | Brazil |
| Hospital de Clinicas de Porto Alegre /ID# 164565 | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 164743 | Botucatu | São Paulo | 18618-686 | Brazil |
| Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP /ID# 164521 | Campinas | São Paulo | 13083-888 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 164768 | Ribeirão Preto | São Paulo | 14051-140 | Brazil |
| Faculdade de Medicina do ABC /ID# 164519 | Santo André | São Paulo | 09060-870 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 164723 | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Instituto de Dermatologia e Estética do Brasil /ID# 164754 | Rio de Janeiro | 22470-220 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 164805 | São Paulo | 05403-000 | Brazil |
| 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 |
|---|---|
| C000601773 | risankizumab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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