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This is a national, multi-center, observational, prospective photographic atlas study in subjects who are treated with infliximab for moderate-to-severe psoriasis in daily clinic according to local country regulations and reimbursement.
Subjects will enter this study using a non-probability sampling method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab | Subjects with moderate-to-severe psoriasis who are treated with infliximab in daily clinics according to local country regulations and reimbursements. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Biological | According to local country regulations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists | Digital pictures of each participant's whole body were taken at each visit. Static PGA was assessed by two dermatologists on the basis of these pictures at a single point in time. The mean of the two readings from the dermatologists was used. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was. | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) |
| Dynamic Photographic PGA Score as Assessed by Two Dermatologists | The dynamic PGA score resulted from the comparison of two sets of pictures/visits. The dynamic PGA was scored twice, at the middle and at the end of the observation period (comparison between picture sets of Week 0 (Visit 1) and Week 14 (Visit 4) visits and comparison between picture sets of Week 0 (Visit 1) and Week 30 (Visit 6) visits. Dynamic PGA was assessed by two dermatologists and the mean of the two readings was used. Clinical improvement was measured with a 10 centimeter (cm)-visual analogue scale (VAS) ranging from 0 (no improvement) to 10 (disappearance of lesions). | Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Static PGA Score as Assessed by the Investigator | Static PGA was assessed at each visit by the investigator. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was. | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) |
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Inclusion Criteria:
Exclusion Criteria:
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Participation to the observational study will be proposed to Dermatology departments by the medical department of the sponsor. Subjects with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label will be asked to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Infliximab | Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Infliximab | Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study. |
| 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 | Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists | Digital pictures of each participant's whole body were taken at each visit. Static PGA was assessed by two dermatologists on the basis of these pictures at a single point in time. The mean of the two readings from the dermatologists was used. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was. | Per protocol analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) |
|
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All 133 participants enrolled in the study were included in the safety population.
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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 | Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA (9.1) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 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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| Dynamic PGA Score as Assessed by the Investigator | The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits. | Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6) |
| Percent Body Surface Area (BSA) Involved With Psoriasis | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5),Week 30 (Visit 6) |
| Psoriasis Area and Severity Index (PASI) Score | PASI ranged from 0 (no symptoms) to 72 (very marked symptoms) and assessed 3 clinical signs within each area (head, arms, trunk, and legs): erythema (redness), induration (thickness), and desquamation (scaling). | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) |
| Nail Psoriasis Severity Index (NAPSI) Score | The nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail was evaluated, and the sum of all the nails was the total NAPSI score. The sum of the scores from all nails ranged from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails). | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) |
| Static PGA Score as Assessed by the Participant | Participants assessed their psoriasis at Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), and Week 30 (Visit 6) according to the Static PGA score, which ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was. | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) |
| Dynamic PGA Score as Assessed by the Participant | The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits. | Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6) |
| Dermatology Life Quality Index (DLQI) Score | DLQI ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life) and was computed by summing the score (each ranging from 0 to 3) of each of a 10-item questionnaire. | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) |
| Number of Participants With Satisfactory Health Status | Participant's opinion on his/her health status, as assessed by the following question: "Think about all the ways your psoriasis is affecting you, do you consider that your current status is satisfactory? (Yes/No)" | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Reason not specified |
|
| Unknown reason |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Static PGA Score as Assessed by the Investigator | Static PGA was assessed at each visit by the investigator. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was. | Per protocol analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) |
|
|
|
| Primary | Dynamic Photographic PGA Score as Assessed by Two Dermatologists | The dynamic PGA score resulted from the comparison of two sets of pictures/visits. The dynamic PGA was scored twice, at the middle and at the end of the observation period (comparison between picture sets of Week 0 (Visit 1) and Week 14 (Visit 4) visits and comparison between picture sets of Week 0 (Visit 1) and Week 30 (Visit 6) visits. Dynamic PGA was assessed by two dermatologists and the mean of the two readings was used. Clinical improvement was measured with a 10 centimeter (cm)-visual analogue scale (VAS) ranging from 0 (no improvement) to 10 (disappearance of lesions). | Per protocol analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6) |
|
|
|
| Secondary | Dynamic PGA Score as Assessed by the Investigator | The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits. | Per protocol analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6) |
|
|
|
| Secondary | Percent Body Surface Area (BSA) Involved With Psoriasis | Per protocol analysis. | Posted | Mean | Standard Deviation | Percent BSA Involved with Psoriasis | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5),Week 30 (Visit 6) |
|
|
|
| Secondary | Psoriasis Area and Severity Index (PASI) Score | PASI ranged from 0 (no symptoms) to 72 (very marked symptoms) and assessed 3 clinical signs within each area (head, arms, trunk, and legs): erythema (redness), induration (thickness), and desquamation (scaling). | Per protocol analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) |
|
|
|
| Secondary | Nail Psoriasis Severity Index (NAPSI) Score | The nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail was evaluated, and the sum of all the nails was the total NAPSI score. The sum of the scores from all nails ranged from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails). | Per protocol analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) |
|
|
|
| Secondary | Static PGA Score as Assessed by the Participant | Participants assessed their psoriasis at Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), and Week 30 (Visit 6) according to the Static PGA score, which ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was. | Per protocol analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) |
|
|
|
| Secondary | Dynamic PGA Score as Assessed by the Participant | The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits. | Per protocol analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6) |
|
|
|
| Secondary | Dermatology Life Quality Index (DLQI) Score | DLQI ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life) and was computed by summing the score (each ranging from 0 to 3) of each of a 10-item questionnaire. | Per protocol analysis. | Posted | Mean | Standard Deviation | Score on a scale | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) |
|
|
|
| Secondary | Number of Participants With Satisfactory Health Status | Participant's opinion on his/her health status, as assessed by the following question: "Think about all the ways your psoriasis is affecting you, do you consider that your current status is satisfactory? (Yes/No)" | Per protocol analysis. | Posted | Number | Participants | Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) |
|
|
|
| 17 |
| 133 |
| 0 |
| 133 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.1) |
|
| Oral pruritus | Gastrointestinal disorders | MedDRA (9.1) |
|
| Palatal oedema | Gastrointestinal disorders | MedDRA (9.1) |
|
| General physical health deterioration | General disorders | MedDRA (9.1) |
|
| Pyrexia | General disorders | MedDRA (9.1) |
|
| Anaphylactic reaction | Immune system disorders | MedDRA (9.1) |
|
| Bronchitis | Infections and infestations | MedDRA (9.1) |
|
| Tuberculosis | Infections and infestations | MedDRA (9.1) |
|
| Tuberculosis test positive | Investigations | MedDRA (9.1) |
|
| Weight decreased | Investigations | MedDRA (9.1) |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.1) |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) |
|
| Paraesthesia | Nervous system disorders | MedDRA (9.1) |
|
| Syncope vasovagal | Nervous system disorders | MedDRA (9.1) |
|
| Polyuria | Renal and urinary disorders | MedDRA (9.1) |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA (9.1) |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (9.1) |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA (9.1) |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (9.1) |
|
Prior to publication or presentation (abstract, poster, oral communication and any other support existing or future), a copy of the final text should be forwarded by the Investigator(s) to the sponsor, for comment and authorization. Such comments and authorization shall aim to ensure the scientific content of the proposed publication and/or presentations and shall ensure that data and the material referring to the sponsor activities receive fair, accurate, and reasonable presentation.
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Visit 4 (n=91) |
|
| Visit 5 (n=81) |
|
| Visit 6 (n=74) |
|
| Title | Measurements |
|---|
|
| Visit 4 (n=91) |
|
| Visit 5 (n=80) |
|
| Visit 6 (n=74) |
|
| Title | Measurements |
|---|---|
|
| Visit 4 (n=90) |
|
| Visit 5 (n=81) |
|
| Visit 6 (n=74) |
|
| Title | Measurements |
|---|---|
|
| Visit 4 (n=64) |
|
| Visit 5 (n=53) |
|
| Visit 6 (n=52) |
|
| Title | Measurements |
|---|---|
|
| Visit 4 (n=87) |
|
| Visit 5 (n=77) |
|
| Visit 6 (n=71) |
|
| Title | Measurements |
|---|---|
|
| Visit 4 (n=79) |
|
| Visit 5 (n=76) |
|
| Visit 6 (n=69) |
|
| Title | Measurements |
|---|---|
|
| Visit 4 (n=83) |
|
| Visit 5 (n=77) |
|
| Visit 6 (n=68) |
|