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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	28 January 2013
Main ID:	NCT01202565
Date of registration:	14/09/2010
Primary sponsor:	AbbVie (prior sponsor, Abbott)
Public title:	Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice
Scientific title:	Effectiveness of Adalimumab (Humira) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice
Date of first enrolment:	September 2010
Target sample size:	555
Recruitment status:	Active, not recruiting
URL:	http://clinicaltrials.gov/show/NCT01202565
Study type:	Observational
Study design:	Time Perspective: Prospective

Countries of recruitment
Czech Republic	Estonia	Hungary	Israel	Romania	Slovakia	Slovenia	Ukraine

Contacts

Name:	Maja Hojnik
Address:
Telephone:
Email:
Affiliation:	AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

Patients will be enrolled in this post-marketing observational study (PMOS) if they
fulfill all of the below criteria:

1. Patients with moderate to severe plaque psoriasis eligible for Humira therapy
according to the local product label and prescription/reimbursement guidelines

2. Have significant psoriatic nail affection (total Nail Psoriasis Severity Index NAPSI
score of hands and feet = 10) and/or significant psoriatic scalp affection (Psoriasis
Scalp Severity Index PSSI score = 10)

3. Adult (=18 years of age)

4. Have negative result of tuberculosis (TB) screening test or TB prophylaxis as per
local guidelines

5. Willing to provide Informed Consent if requested by the Local Law Regulations

Exclusion Criteria:

Patients fulfilling any of the below exclusion criteria will not be eligible for this
post-marketing observational study (PMOS):

1. Meet contraindications as outlined in the latest version of the local Summary of
Product Characteristics (SmPC)

2. Participate in another clinical/observational study

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Moderate to Severe Plaque Psoriasis

Intervention(s)

Primary Outcome(s)

For patients with nail affection: Mean percent improvement in Nail Psoriasis Severity Index (NAPSI) score from baseline to 12 months on Humira therapy. The two most affected nails will be taken into account. [Time Frame: 12 months]

For patients with scalp affection: Mean percent improvement in Psoriasis Scalp Severity Index (PSSI) score from baseline to 12 months on Humira therapy [Time Frame: 12 months]

For patients with scalp affection: Mean percent improvement in Psoriasis Scalp Severity Index (PSSI) score from baseline to 12 months on Humira therapy [Time Frame: 3 months]

For patients with scalp affection: Mean percent improvement in Psoriasis Scalp Severity Index (PSSI) score from baseline to 12 months on Humira therapy [Time Frame: 6 months]

For patients with scalp affection: Mean percent improvement in Psoriasis Scalp Severity Index (PSSI) score from baseline to 12 months on Humira therapy [Time Frame: 9 months]

For patients with scalp affection: Mean percent improvement in Psoriasis Scalp Severity Index (PSSI) score from baseline to 12 months on Humira therapy [Time Frame: baseline]

Secondary Outcome(s)

All patients: Change in Dermatology Life Quality Index (DLQI) score from baseline [Time Frame: 12 months]

All patients: Change in Dermatology Life Quality Index (DLQI) score from baseline [Time Frame: 3 months]

All patients: Change in Dermatology Life Quality Index (DLQI) score from baseline [Time Frame: 6 months]

All patients: Change in Dermatology Life Quality Index (DLQI) score from baseline [Time Frame: 9 months]

All patients: Change in Dermatology Life Quality Index (DLQI) score from baseline [Time Frame: baseline]

All patients: Change in mean Psoriasis Area and Severity Index (PASI) score from baseline [Time Frame: 12 months]

All patients: Change in mean Psoriasis Area and Severity Index (PASI) score from baseline [Time Frame: 3 months]

All patients: Change in mean Psoriasis Area and Severity Index (PASI) score from baseline [Time Frame: 6 months]

All patients: Change in mean Psoriasis Area and Severity Index (PASI) score from baseline [Time Frame: 9 months]

All patients: Change in mean Psoriasis Area and Severity Index (PASI) score from baseline [Time Frame: baseline]

All patients: Correlation between the percentages of improvement in Psoriasis Area Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI) or Psoriasis Scalp Severity Index (PSSI) and Dermatology Life Quality Index (DLQI) [Time Frame: 12 months]

All patients: Correlation between the percentage of improvement in Psoriasis Area and Severity Index (PASI) and Nail Psoriasis Severity Index (NAPSI) or Psoriasis Scalp Severity Index (PSSI) [Time Frame: 12 months]

All patients: Mean percent improvement in Dermatology Life Quality Index (DLQI) score [Time Frame: 12 months]

All patients: Mean percent improvement in Dermatology Life Quality Index (DLQI) score [Time Frame: 3 months]

All patients: Mean percent improvement in Dermatology Life Quality Index (DLQI) score [Time Frame: 6 months]

All patients: Mean percent improvement in Dermatology Life Quality Index (DLQI) score [Time Frame: 9 months]

All patients: Mean percent improvement in Dermatology Life Quality Index (DLQI) score [Time Frame: baseline]

All patients: Mean percent improvement in Psoriasis Area and Severity Index (PASI) score from baseline [Time Frame: 12 months]

All patients: Mean percent improvement in Psoriasis Area and Severity Index (PASI) score from baseline [Time Frame: 3 months]

All patients: Mean percent improvement in Psoriasis Area and Severity Index (PASI) score from baseline [Time Frame: 6 months]

All patients: Mean percent improvement in Psoriasis Area and Severity Index (PASI) score from baseline [Time Frame: 9 months]

All patients: Mean percent improvement in Psoriasis Area and Severity Index (PASI) score from baseline [Time Frame: baseline]

All patients: Percentage (%) of patients achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 and PASI 90 response) [Time Frame: 12 months]

All patients: Percentage (%) of patients achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 and PASI 90 response) [Time Frame: 3 months]

All patients: Percentage (%) of patients achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 and PASI 90 response) [Time Frame: 6 months]

All patients: Percentage (%) of patients achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 and PASI 90 response) [Time Frame: 9 months]

All patients: Percentage (%) of patients achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 and PASI 90 response) [Time Frame: baseline]

Nail affection: Change in mean Nail Psoriasis Severity Index (NAPSI) score from baseline [Time Frame: 12 months]

Nail affection: Change in mean Nail Psoriasis Severity Index (NAPSI) score from baseline [Time Frame: 3 months]

Nail affection: Change in mean Nail Psoriasis Severity Index (NAPSI) score from baseline [Time Frame: 6 months]

Nail affection: Change in mean Nail Psoriasis Severity Index (NAPSI) score from baseline [Time Frame: 9 months]

Nail affection: Change in mean Nail Psoriasis Severity Index (NAPSI) score from baseline [Time Frame: baseline]

Nail affection: Percentage (%) of patients achieving complete clearing of nails ( Nail Psoriasis Severity Index NAPSI 0) [Time Frame: 12 months]

Nail affection: Percentage (%) of patients achieving complete clearing of nails ( Nail Psoriasis Severity Index NAPSI 0) [Time Frame: 3 months]

Nail affection: Percentage (%) of patients achieving complete clearing of nails ( Nail Psoriasis Severity Index NAPSI 0) [Time Frame: 6 months]

Nail affection: Percentage (%) of patients achieving complete clearing of nails ( Nail Psoriasis Severity Index NAPSI 0) [Time Frame: 9 months]

Nail affection: Percentage (%) of patients achieving complete clearing of nails ( Nail Psoriasis Severity Index NAPSI 0) [Time Frame: baseline]

Nail affection: Percentage (%) of patients achieving good clinical response on nails defined as = 50% improvement in total Nail Psoriasis Severity Index NAPSI [Time Frame: 12 months]

Nail affection: Percentage (%) of patients achieving good clinical response on nails defined as = 50% improvement in total Nail Psoriasis Severity Index NAPSI [Time Frame: 3 months]

Nail affection: Percentage (%) of patients achieving good clinical response on nails defined as = 50% improvement in total Nail Psoriasis Severity Index NAPSI [Time Frame: 6 months]

Nail affection: Percentage (%) of patients achieving good clinical response on nails defined as = 50% improvement in total Nail Psoriasis Severity Index NAPSI [Time Frame: 9 months]

Nail affection: Percentage (%) of patients achieving good clinical response on nails defined as = 50% improvement in total Nail Psoriasis Severity Index NAPSI [Time Frame: baseline]

Scalp affection: Change in mean Psoriasis Scalp Severity Index (PSSI) score from baseline [Time Frame: 12 months]

Scalp affection: Change in mean Psoriasis Scalp Severity Index (PSSI) score from baseline [Time Frame: 3 months]

Scalp affection: Change in mean Psoriasis Scalp Severity Index (PSSI) score from baseline [Time Frame: 6 months]

Scalp affection: Change in mean Psoriasis Scalp Severity Index (PSSI) score from baseline [Time Frame: 9 months]

Scalp affection: Change in mean Psoriasis Scalp Severity Index (PSSI) score from baseline [Time Frame: baseline]

Scalp affection: Percentage (%) of patients achieving complete clearing of scalp (Psoriasis Scalp Severity Index PSSI 0) [Time Frame: 12 months]

Scalp affection: Percentage (%) of patients achieving complete clearing of scalp (Psoriasis Scalp Severity Index PSSI 0) [Time Frame: 3 months]

Scalp affection: Percentage (%) of patients achieving complete clearing of scalp (Psoriasis Scalp Severity Index PSSI 0) [Time Frame: 6 months]

Scalp affection: Percentage (%) of patients achieving complete clearing of scalp (Psoriasis Scalp Severity Index PSSI 0) [Time Frame: 9 months]

Scalp affection: Percentage (%) of patients achieving complete clearing of scalp (Psoriasis Scalp Severity Index PSSI 0) [Time Frame: baseline]

Scalp affection: Percentage (%) of patients achieving good clinical response on scalp defined as = 50% improvement in Psoriasis Scalp Severity Index (PSSI) score [Time Frame: 12 months]

Scalp affection: Percentage (%) of patients achieving good clinical response on scalp defined as = 50% improvement in Psoriasis Scalp Severity Index (PSSI) score [Time Frame: 3 months]

Scalp affection: Percentage (%) of patients achieving good clinical response on scalp defined as = 50% improvement in Psoriasis Scalp Severity Index (PSSI) score [Time Frame: 6 months]

Scalp affection: Percentage (%) of patients achieving good clinical response on scalp defined as = 50% improvement in Psoriasis Scalp Severity Index (PSSI) score [Time Frame: 9 months]

Scalp affection: Percentage (%) of patients achieving good clinical response on scalp defined as = 50% improvement in Psoriasis Scalp Severity Index (PSSI) score [Time Frame: baseline]

Secondary ID(s)

P12-165

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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