Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice
NCT ID: NCT01202565
Last Updated: 2014-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
506 participants
OBSERVATIONAL
2010-09-30
2013-07-31
Brief Summary
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The aim of this PMOS is to evaluate the long-term (12-month) efficacy of adalimumab in the treatment of nail and scalp psoriatic lesions in routine dermatologic practice.
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Detailed Description
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Follow-up visits are not strictly scheduled, but rather left to the judgment of each investigator within the 12-month study period for each participant. Five visits are indicated within the 12-month observational period: Baseline and follow-up at 3 months, 6 months, 9 months and at 12 months (Study End).
As nails are not included in the general measures of disease severity (such as Psoriasis Area and Severity Index \[PASI\]), the Nail Psoriasis Severity Index (NAPSI) will be used to assign a score of nail psoriasis. The scalp, though being involved in the general measures of disease severity (e.g. PASI), represents only 4-5% of the body surface and is therefore poorly represented. Psoriasis Scalp Severity Index (PSSI) will be used to quantify the intensity of scalp psoriasis and its changes during the study. The association between general skin and localized nail and scalp, and changes in quality of life in response to adalimumab therapy will also be examined.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Adalimumab
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
2. Participate in another clinical/observational study
18 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Jaka Brumen
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 63776
Chotoviny, , Czechia
Site Reference ID/Investigator# 58083
Jihlava, , Czechia
Site Reference ID/Investigator# 56762
Klimkovice, , Czechia
Site Reference ID/Investigator# 56763
Klimkovice, , Czechia
Site Reference ID/Investigator# 30742
Kostelec nad Ohří, , Czechia
Site Reference ID/Investigator# 54503
Prague, , Czechia
Site Reference ID/Investigator# 56542
Prague, , Czechia
Site Reference ID/Investigator# 58084
Prague, , Czechia
Site Reference ID/Investigator# 57562
Tallinn, , Estonia
Site Reference ID/Investigator# 57563
Tallinn, , Estonia
Site Reference ID/Investigator# 57564
Tallinn, , Estonia
Site Reference ID/Investigator# 57567
Tartu, , Estonia
Site Reference ID/Investigator# 30743
Budapest, , Hungary
Site Reference ID/Investigator# 42506
Debrecen, , Hungary
Site Reference ID/Investigator# 42507
Debrecen, , Hungary
Site Reference ID/Investigator# 42508
Debrecen, , Hungary
Site Reference ID/Investigator# 42509
Debrecen, , Hungary
Site Reference ID/Investigator# 42510
Debrecen, , Hungary
Site Reference ID/Investigator# 42514
Kaposvár, , Hungary
Site Reference ID/Investigator# 42515
Kecskemét, , Hungary
Site Reference ID/Investigator# 42516
Miskolc, , Hungary
Site Reference ID/Investigator# 42511
Pécs, , Hungary
Site Reference ID/Investigator# 42512
Pécs, , Hungary
Site Reference ID/Investigator# 42513
Pécs, , Hungary
Site Reference ID/Investigator# 44854
Pécs, , Hungary
Site Reference ID/Investigator# 42502
Szeged, , Hungary
Site Reference ID/Investigator# 42517
Szombathely, , Hungary
Site Reference ID/Investigator# 30744
Afula, , Israel
Site Reference ID/Investigator# 49888
Jerusalem, , Israel
Site Reference ID/Investigator# 49886
Petach Tiqwa, , Israel
Site Reference ID/Investigator# 49887
Ramat Gan, , Israel
Site Reference ID/Investigator# 51783
Tel Aviv, , Israel
Site Reference ID/Investigator# 46184
Alexandria, , Romania
Site Reference ID/Investigator# 44580
Bucharest, , Romania
Site Reference ID/Investigator# 44572
Bucharest, , Romania
Site Reference ID/Investigator# 44575
Bucharest, , Romania
Site Reference ID/Investigator# 44576
Bucharest, , Romania
Site Reference ID/Investigator# 46185
Bucharest, , Romania
Site Reference ID/Investigator# 44563
Bucharest, , Romania
Site Reference ID/Investigator# 44564
Bucharest, , Romania
Site Reference ID/Investigator# 44566
Bucharest, , Romania
Site Reference ID/Investigator# 44567
Bucharest, , Romania
Site Reference ID/Investigator# 44569
Bucharest, , Romania
Site Reference ID/Investigator# 44571
Bucharest, , Romania
Site Reference ID/Investigator# 30745
Cluj-Napoca, , Romania
Site Reference ID/Investigator# 44561
Constanța, , Romania
Site Reference ID/Investigator# 44562
Constanța, , Romania
Site Reference ID/Investigator# 44557
Craiova, , Romania
Site Reference ID/Investigator# 44558
Craiova, , Romania
Site Reference ID/Investigator# 44559
Craiova, , Romania
Site Reference ID/Investigator# 44560
Craiova, , Romania
Site Reference ID/Investigator# 44547
Iași, , Romania
Site Reference ID/Investigator# 44548
Iași, , Romania
Site Reference ID/Investigator# 44549
Iași, , Romania
Site Reference ID/Investigator# 46183
Oradea, , Romania
Site Reference ID/Investigator# 44555
Ploieşti, , Romania
Site Reference ID/Investigator# 44554
Reghin, , Romania
Site Reference ID/Investigator# 44550
Târgu Mureş, , Romania
Site Reference ID/Investigator# 30746
Banská Bystrica, , Slovakia
Site Reference ID/Investigator# 42521
Bratislava, , Slovakia
Site Reference ID/Investigator# 42519
Košice, , Slovakia
Site Reference ID/Investigator# 42522
Martin, , Slovakia
Site Reference ID/Investigator# 42518
Prešov, , Slovakia
Site Reference ID/Investigator# 30747
Ljubljana, , Slovenia
Site Reference ID/Investigator# 44544
Ljubljana, , Slovenia
Site Reference ID/Investigator# 44542
Maribor, , Slovenia
Site Reference ID/Investigator# 47702
Sežana, , Slovenia
Site Reference ID/Investigator# 64524
Donetsk, , Ukraine
Site Reference ID/Investigator# 66642
Donetsk, , Ukraine
Site Reference ID/Investigator# 62304
Kharkiv, , Ukraine
Site Reference ID/Investigator# 56699
Kiev, , Ukraine
Site Reference ID/Investigator# 55443
Lviv, , Ukraine
Site Reference ID/Investigator# 70493
Lviv, , Ukraine
Countries
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Related Links
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Related Info
Other Identifiers
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P12-165
Identifier Type: -
Identifier Source: org_study_id
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