An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation

Study Overview
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Brief Summary
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This is an open-label study designed to establish the safety and effectiveness of adalimumab in the treatment of moderate to severe plaque psoriasis after 24 weeks of treatment.

Detailed Description
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During the treatment period, participants will receive an initial adalimumab 80 milligram (mg) subcutaneous (sc) dose, followed by adalimumab 40 mg sc every other week starting one week after initial dose. Safety and effectiveness assessments will be completed at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 24. Participants may discontinue adalimumab treatment at any time during study participation. Participants that end study participation early will have a Premature Discontinuation visit. All participants who do not initiate commercial Humira® will have a follow-up phone call 70 days after the last administration of study drug to obtain information on any new or ongoing Adverse Events (AEs). The 70-day follow-up phone call will not be required for any participant that initiates adalimumab therapy not supplied in the context of the clinical trial after the end of study participation.

Official Title
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An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab (Humira®) in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation

Conditions
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Moderate to Severe Plaque Psoriasis

Intervention / Treatment
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* Biological: Adalimumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient will be eligible for study participation if he/she meets the following criteria: Male and female patients ≥ 18 years of age. Clinical diagnosis of psoriasis for at least 6 months as determined by patient interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator. Stable plaque psoriasis for at least 2 months before Screening and Baseline visits as determined by patient interview of his/her medical history. Moderate to severe plaque psoriasis defined by ≥ 10% Body Surface Area (BSA) involvement at the Baseline visit. PASI (Psoriasis Area and Severity Index) score ≥ 10 at the Baseline visit. Exclusion Criteria: Diagnosis of erythrodermic psoriasis, pustular psoriasis, medication induced or medication-exacerbated psoriasis or new onset of guttate psoriasis. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis. Patient who cannot discontinue topical therapies for the treatment of psoriasis such as corticosteroids, vitamin D analogs, or retinoids at least 14 days prior to the Baseline (Week 0) visit and during the study. Participants are allowed to use: Shampoos that contain no corticosteroid; Bland (without beta or alpha hydroxy acids or containing no psoriasis treatment) emollients; Low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only. Patient who cannot avoid UVB (Ultraviolet-B) phototherapy for at least 14 days prior to the Baseline (Week 0) visit and during the study. Patient who cannot avoid PUVA (psoralen + ultraviolet A) phototherapy for at least 28 days prior to the Baseline (Week 0) visit and during the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Adalimumab<br>Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. | Biological: Adalimumab<br> <br> * Other names: Humira;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24 | The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving a Physician's Global Assessment of Clear | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared; 1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal; 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild; 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate; 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked; 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe. The percentage of participants achieving a PGA score of clear (0) is reported. | Weeks 2, 4, 8, 12, 16 and 24 | 
| Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared; 1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal; 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild; 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate; 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked; 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe. The percentage of participants achieving a PGA score of clear (0) or minimal (1) is reported. | Weeks 2, 4, 8, 12, 16 and 24 | 
| Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA) | The PGA is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared; 1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal; 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild; 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate; 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked; 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe. The percentage of participants achieving a shift from Baseline to a less severe category is reported. | Baseline and Weeks 2, 4, 8, 12, 16 and 24 | 
| Percentage of Participants Achieving a PASI 50 Response | The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. | Baseline and Weeks 2, 4, 8, 12, 16, and 24 | 
| Percentage of Participants Achieving a PASI 75 Response | The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. | Baseline and Weeks 2, 4, 8, 12, and 16 | 
| Percentage of Participants Achieving a PASI 90 Response | The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. | Baseline and Weeks 2, 4, 8, 12, 16, and 24 | 
| Percentage of Participants Achieving a PASI 100 Response | The percentage of participants with a 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. | Baseline and Weeks 2, 4, 8, 12, 16, and 24 | 
| Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement. | Baseline and Weeks 2, 4, 8, 12, 16, and 24 | 
| Percent Change From Baseline in Dermatology Life Quality Index (DLQI) | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement. | Baseline and Weeks 8, 12, and 24 | 
| Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The most affected fingernail was determined at Baseline and used for the analysis. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salman patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: 0 = none; 1 = present in 1/4 nail quadrants; 2 = present in 2/4 nail quadrants; 3 = present in 3/4 nail quadrants; 4 = present in 4/4 nail quadrants. The sum of these two scores is the total score for the nail, and ranges from 0 (no nail psoriasis) to 8 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Week 24 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement. | Baseline and Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate to Severe Plaque Psoriasis