- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01644396
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
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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Ekaterinburg, Russische Föderation, 620076
- Site Reference ID/Investigator# 67547
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Kazan, Russische Föderation, 420012
- Site Reference ID/Investigator# 78433
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Moscow, Russische Föderation, 107076
- Site Reference ID/Investigator# 67542
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Saratov, Russische Föderation, 410028
- Site Reference ID/Investigator# 67546
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Smolensk, Russische Föderation, 214018
- Site Reference ID/Investigator# 78417
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St. Petersburg, Russische Föderation, 190013
- Site Reference ID/Investigator# 78413
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St. Petersburg, Russische Föderation, 194044
- Site Reference ID/Investigator# 67545
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Sonstiges: Adalimumab
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.
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Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
Zeitfenster: Baseline and Week 24
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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.
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Baseline and Week 24
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Percentage of Participants Achieving a Physician's Global Assessment of Clear
Zeitfenster: Weeks 2, 4, 8, 12, 16 and 24
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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:
The percentage of participants achieving a PGA score of clear (0) is reported. |
Weeks 2, 4, 8, 12, 16 and 24
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Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal
Zeitfenster: Weeks 2, 4, 8, 12, 16 and 24
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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:
The percentage of participants achieving a PGA score of clear (0) or minimal (1) is reported. |
Weeks 2, 4, 8, 12, 16 and 24
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Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)
Zeitfenster: Baseline and Weeks 2, 4, 8, 12, 16 and 24
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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:
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
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Percentage of Participants Achieving a PASI 50 Response
Zeitfenster: Baseline and Weeks 2, 4, 8, 12, 16, and 24
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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.
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Baseline and Weeks 2, 4, 8, 12, 16, and 24
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Percentage of Participants Achieving a PASI 75 Response
Zeitfenster: Baseline and Weeks 2, 4, 8, 12, and 16
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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.
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Baseline and Weeks 2, 4, 8, 12, and 16
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Percentage of Participants Achieving a PASI 90 Response
Zeitfenster: Baseline and Weeks 2, 4, 8, 12, 16, and 24
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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.
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Baseline and Weeks 2, 4, 8, 12, 16, and 24
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Percentage of Participants Achieving a PASI 100 Response
Zeitfenster: Baseline and Weeks 2, 4, 8, 12, 16, and 24
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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.
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Baseline and Weeks 2, 4, 8, 12, 16, and 24
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Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Zeitfenster: Baseline and Weeks 2, 4, 8, 12, 16, and 24
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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
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Percent Change From Baseline in Dermatology Life Quality Index (DLQI)
Zeitfenster: Baseline and Weeks 8, 12, and 24
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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.
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Baseline and Weeks 8, 12, and 24
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Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Zeitfenster: Baseline and Week 24
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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:
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
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change From Baseline in Hemoglobin
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Hematocrit
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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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).
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Red Blood Cell Count
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Blood Cell Counts
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Erythrocyte Sedimentation Rate
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Alanine Aminotransferase
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Aspartate Aminotransferase
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Alkaline Phosphatase
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Total Bilirubin
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Creatinine
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Blood Urea Nitrogen (BUN)
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Uric Acid
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Inorganic Phosphate
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Calcium, Sodium and Potassium
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Glucose
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Albumin
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Total Protein
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Cholesterol
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Triglycerides
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Urine pH
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Urine Specific Gravity
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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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.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Blood Pressure
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Pulse
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Respiratory Rate
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Weight
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Change From Baseline in Body Temperature
Zeitfenster: Baseline and Week 24 (or Early Termination Visit)
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Safety variables included laboratory data, vital signs and adverse events.
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Baseline and Week 24 (or Early Termination Visit)
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Number of Participants With Adverse Events (AEs)
Zeitfenster: From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
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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. |
From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Martin Okun, MD, AbbVie
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- M13-279
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