Clinical trial 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
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Moderate to Severe Plaque Psoriasis
Keywords: Moderate to Severe Plaque Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-07-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

A patient will be eligible for study participation if he/she meets the following criteria:

1. Male and female patients ≥ 18 years of age.
2. 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.
3. Stable plaque psoriasis for at least 2 months before Screening and Baseline visits as determined by patient interview of his/her medical history.
4. Moderate to severe plaque psoriasis defined by ≥ 10% Body Surface Area (BSA) involvement at the Baseline visit.
5. PASI (Psoriasis Area and Severity Index) score ≥ 10 at the Baseline visit.

Exclusion Criteria:

1. Diagnosis of erythrodermic psoriasis, pustular psoriasis, medication induced or medication-exacerbated psoriasis or new onset of guttate psoriasis.
2. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
3. 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.
4. Patient who cannot avoid UVB (Ultraviolet-B) phototherapy for at least 14 days prior to the Baseline (Week 0) visit and during the study.
5. 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.

Primary outcomes:
measure: Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving a Physician's Global Assessment of Clear
timeFrame: Weeks 2, 4, 8, 12, 16 and 24
measure: Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal
timeFrame: Weeks 2, 4, 8, 12, 16 and 24
measure: Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16 and 24
measure: Percentage of Participants Achieving a PASI 50 Response
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, and 24
measure: Percentage of Participants Achieving a PASI 75 Response
timeFrame: Baseline and Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants Achieving a PASI 90 Response
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, and 24
measure: Percentage of Participants Achieving a PASI 100 Response
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, and 24
measure: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, and 24
measure: Percent Change From Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline and Weeks 8, 12, and 24
measure: Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
timeFrame: Baseline and Week 24
Other outcomes:
measure: Change From Baseline in Hemoglobin
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Hematocrit
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Red Blood Cell Count
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Blood Cell Counts
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Erythrocyte Sedimentation Rate
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Alanine Aminotransferase
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Aspartate Aminotransferase
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Alkaline Phosphatase
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Total Bilirubin
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Creatinine
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Blood Urea Nitrogen (BUN)
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Uric Acid
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Inorganic Phosphate
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Calcium, Sodium and Potassium
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Glucose
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Albumin
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Total Protein
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Cholesterol
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Triglycerides
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Urine pH
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Urine Specific Gravity
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Blood Pressure
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Pulse
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Respiratory Rate
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Weight
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Change From Baseline in Body Temperature
timeFrame: Baseline and Week 24 (or Early Termination Visit)
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Site Reference ID/Investigator# 67547
city: Kazan
country: Russian Federation
facility: Site Reference ID/Investigator# 78433
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 67542
city: Saratov
country: Russian Federation
facility: Site Reference ID/Investigator# 67546
city: Smolensk
country: Russian Federation
facility: Site Reference ID/Investigator# 78417
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 78413
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 67545
Study officials:
affiliation: AbbVie
name: Martin Okun, MD
role: STUDY_DIRECTOR
References: