Back to resultsAn Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation
Primary Purpose
Moderate to Severe Plaque Psoriasis
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Plaque Psoriasis focused on measuring Moderate to Severe Plaque Psoriasis
Eligibility Criteria
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.
Sites / Locations
- Site Reference ID/Investigator# 67547
- Site Reference ID/Investigator# 78433
- Site Reference ID/Investigator# 67542
- Site Reference ID/Investigator# 67546
- Site Reference ID/Investigator# 78417
- Site Reference ID/Investigator# 78413
- Site Reference ID/Investigator# 67545
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Adalimumab
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01644396
First Posted
May 7, 2012
Last Updated
September 22, 2014
Sponsor
AbbVie (prior sponsor, Abbott)
1. Study Identification
Unique Protocol Identification Number
NCT01644396
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Plaque Psoriasis
Keywords
Moderate to Severe Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adalimumab
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
Description
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.
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving a Physician's Global Assessment of Clear
Description
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.
Time Frame
Weeks 2, 4, 8, 12, 16 and 24
Title
Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal
Description
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.
Time Frame
Weeks 2, 4, 8, 12, 16 and 24
Title
Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16 and 24
Title
Percentage of Participants Achieving a PASI 50 Response
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, and 24
Title
Percentage of Participants Achieving a PASI 75 Response
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8, 12, and 16
Title
Percentage of Participants Achieving a PASI 90 Response
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, and 24
Title
Percentage of Participants Achieving a PASI 100 Response
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, and 24
Title
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, and 24
Title
Percent Change From Baseline in Dermatology Life Quality Index (DLQI)
Description
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.
Time Frame
Baseline and Weeks 8, 12, and 24
Title
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Description
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.
Time Frame
Baseline and Week 24
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Hemoglobin
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Hematocrit
Description
Safety variables included laboratory data, vital signs and adverse events. The hematocrit measures the volume of red blood cells compared to the total blood volume (red blood cells and plasma).
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Red Blood Cell Count
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Blood Cell Counts
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Erythrocyte Sedimentation Rate
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Alanine Aminotransferase
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Aspartate Aminotransferase
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Alkaline Phosphatase
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Total Bilirubin
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Creatinine
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Blood Urea Nitrogen (BUN)
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Uric Acid
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Inorganic Phosphate
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Calcium, Sodium and Potassium
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Glucose
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Albumin
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Total Protein
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Cholesterol
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Triglycerides
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Urine pH
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Urine Specific Gravity
Description
Safety variables included laboratory data, vital signs and adverse events. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Blood Pressure
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Pulse
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Respiratory Rate
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Weight
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Change From Baseline in Body Temperature
Description
Safety variables included laboratory data, vital signs and adverse events.
Time Frame
Baseline and Week 24 (or Early Termination Visit)
Title
Number of Participants With Adverse Events (AEs)
Description
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment.
The investigator rated the severity of each AE as either:
Mild: The AE is transient and easily tolerated; Moderate: The AE causes the participant discomfort and interrupts usual activities.
Severe: The AE causes considerable interference with usual activities and may be incapacitating or life-threatening.
A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome.
Drug-related AEs are those assessed by the investigator as either probably or possibly related.
Other malignancy excludes lymphoma, hepatosplenic T-cell lymphoma (HSTCL), leukemia, non-melanoma skin cancer (NMSC), and melanoma.
Time Frame
From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Okun, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 67547
City
Ekaterinburg
ZIP/Postal Code
620076
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 78433
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 67542
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 67546
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 78417
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 78413
City
St. Petersburg
ZIP/Postal Code
190013
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 67545
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
12. IPD Sharing Statement
Links:
URL
http://rxabbvie.com
Description
Related Info
Learn more about this trial
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
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