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| Name | Class |
|---|---|
| Assign Data Management and Biostatistics GmbH | OTHER |
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The aim of this post-marketing observational study (PMOS) was to obtain further data on long-term safety, efficacy, and quality of life outcomes for adalimumab in routine clinical use in participants with moderate to severe chronic plaque psoriasis after unsustainable clinical response to other biologic disease modifying anti-rheumatic drugs (BDMARDs). There are few data so far showing the effects of switching from other BDMARDs to adalimumab in patients with moderate to severe chronic plaque psoriasis. This study was designed to evaluate the long-term effectiveness of adalimumab in participants with moderate to severe chronic plaque psoriasis using the Psoriasis Area and Severity Index (PASI) in participants previously treated with efalizumab, infliximab, or etanercept and who either never achieved satisfactory response, achieved satisfactory response initially but lost it over time, or discontinued treatment due to intolerance/side effect(s) or other reasons, for example after regular stop of etanercept.
This was a non-interventional PMOS conducted in a prospective, single-country, multicenter format to assess the quality of life of psoriasis patients taking adalimumab as prescribed by their physician in accordance with the terms of the local marketing authorization with regard to dose, population, and indication. The prescription of adalimumab was clearly separated from the decision to include the participant in this study. No procedures other than standard of care were to have been performed. Visits were non-interventional and timing of participant appointments was left to each physician. After therapy initiation, visits occurred over 12 months usually close to Weeks 4, 12, 24, 36, and 52 for a total of 6 visits (Visits 1 through 6 including Screening). Because participant visits were left to the physician, participant failure to meet the suggested visit weeks did not constitute a breach of the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure |
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| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) Score | Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome). | Inclusion visit (Week 0), Week 4, Week 36, Week 52 |
| Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75) | PASI75 is the number of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52 (final visit). PASI score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome). | Inclusion visit (Week 0) to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Dermatology Life Quality Index (DLQI) Score | Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst). |
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Inclusion Criteria:
Exclusion Criteria:
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Hospital, Dermatology
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| Name | Affiliation | Role |
|---|---|---|
| Astrid Dworan-Timler, MD | Abbott Austria | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 27435 | Feldkirch | 6807 | Austria | |||
| Site Reference ID/Investigator# 27436 |
Three participants were excluded from the database because they had been treated with adalimumab prior to their Visit 1. Statistical analysis has been performed for the 42 participants included in the All Treated population.
A total of 46 participants were screened for this PMOS at 9 study sites in Austria. One participant did not meet entry criteria (screening failure), and 45 participants were enrolled and received treatment with adalimumab in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Psoriasis Area and Severity Index (PASI) Score | Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome). | Analysis was performed on the All Treated population using an observed case approach. PASI score was assessed at Weeks 0, 4, 36, and 52 in 41, 36, 28, and 27 participants, respectively. | Posted | Mean | Standard Deviation | units on a scale | Inclusion visit (Week 0), Week 4, Week 36, Week 52 |
|
Up to 1 year (from the time of participant consent through the final Week 52 visit) plus 70 days following administration of the last dose of physician-prescribed study treatment.
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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 | Adalimumab | Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute tonsillitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
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| Inclusion visit (Week 0), Week 4, Week 36, Week 52 |
| Nail Psoriasis Severity Index (NAPSI) Score | The nails are graded for nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Per nail, the NAPSI score ranges from 0 (no nail psoriasis) to 4 (most severe nail psoriasis). | Inclusion visit (Week 0), Week 4, Week 36, and Week 52 |
| Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions | Tolerability and safety were assessed by collecting adverse events during the course of the study up to 70 days following the last dose of physician-prescribed adalimumab. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details. | From the time of participant consent until 70 days after last dose of study drug |
| Graz |
| 8010 |
| Austria |
| Site Reference ID/Investigator# 38445 | Graz | 8036 | Austria |
| Site Reference ID/Investigator# 27443 | Linz | 4020 | Austria |
| Site Reference ID/Investigator# 27442 | Vienna | 1030 | Austria |
| Site Reference ID/Investigator# 27440 | Vienna | 1130 | Austria |
| Site Reference ID/Investigator# 27437 | Vienna | 1160 | Austria |
| Site Reference ID/Investigator# 27439 | Vienna | A-1090 | Austria |
| Site Reference ID/Investigator# 23309 | Wels | 4600 | Austria |
| Non-compliance |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75) | PASI75 is the number of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52 (final visit). PASI score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome). | Analysis was performed on the All Treated population using an observed case approach. PASI response was assessed in 26 participants at Week 52. | Posted | Number | participants | Inclusion visit (Week 0) to Week 52 |
|
|
|
| Secondary | Dermatology Life Quality Index (DLQI) Score | Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst). | Analysis was performed on the All Treated population using an observed case approach. DLQI score was assessed at Weeks 0, 4, 36, and 52 in 36, 34, 26, and 27 participants, respectively. | Posted | Mean | Standard Deviation | units on a scale | Inclusion visit (Week 0), Week 4, Week 36, Week 52 |
|
|
|
| Secondary | Nail Psoriasis Severity Index (NAPSI) Score | The nails are graded for nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Per nail, the NAPSI score ranges from 0 (no nail psoriasis) to 4 (most severe nail psoriasis). | Analysis was performed using an observed case approach. For the All Treated population, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 34, 30, 24, and 25 participants, respectively. For the Subgroup with nail psoriasis, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 18, 16, 12, and 13 participants, respectively. | Posted | Mean | Standard Deviation | units on a scale | Inclusion visit (Week 0), Week 4, Week 36, and Week 52 |
|
|
|
| Secondary | Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions | Tolerability and safety were assessed by collecting adverse events during the course of the study up to 70 days following the last dose of physician-prescribed adalimumab. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details. | Analysis was performed on the All Treated population. | Posted | Number | participants | From the time of participant consent until 70 days after last dose of study drug |
|
|
|
| 1 |
| 42 |
| 8 |
| 42 |
| Arthroscopic surgery | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Injection site urticaria | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Measurements |
|---|---|
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| Week 52 |
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| Week 36 |
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| Week 52 |
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