Clinical trial NCT01202565: Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate to Severe Plaque Psoriasis
Keywords: Post-marketing observational study (PMOS) Protocol
Moderate to Severe Plaque Psoriasis
Treatment of Scalp and Nail Affection
Effectiveness of Adalimumab (HUMIRA®)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Per this PMOS protocol, the study population will consists of adult patients with moderate to severe plaque psoriasis who have failed to respond to, have a contraindication to, or are intolerant of other systemic therapies including cyclosporine, methotrexate or PUVA (photochemotherapy combining psoralen with ultraviolet A treatment), and exhibit a significant psoriatic affection of the scalp and/or nails.

Brief summary: There is clearly a need for further data on the efficacy of biologic agents in the treatment of nail and scalp psoriasis, especially in the routine clinical setting. A few case reports can be found, but no published data exists from non-interventional studies, such as post-marketing observational studies (PMOS) that reflect routine clinical practice.

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.

Detailed description: This is post-marketing observational study (PMOS) in which HUMIRA® is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication, and following the local prescription and/or reimbursement guidance.

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.

Eligibility criteria: Inclusion Criteria:

Patients will be enrolled in this 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 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

Primary outcomes:
measure: Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12
timeFrame: Baseline and Month 12
measure: Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to Month 12
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
timeFrame: Baseline and Months 3, 6, 9, and 12
measure: Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis
timeFrame: Baseline and Months 3, 6, 9, and 12
measure: Percentage of Participants Achieving Complete Clearing of Nails
timeFrame: Months 3, 6, 9, and 12
measure: Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
timeFrame: Baseline and Months 3, 6, 9, and 12
measure: Percentage of Participants Achieving Good Clinical Response on Scalp
timeFrame: Baseline and Months 3, 6, 9, and 12
measure: Percentage of Participants Achieving Complete Clearing of Scalp
timeFrame: Months 3, 6, 9, and 12
measure: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
timeFrame: Baseline and Month 12
measure: Change From Baseline in PASI Score
timeFrame: Baseline and Months 3, 6, 9, and 12
measure: Percentage of Participants Achieving a PASI 90 Response
timeFrame: Baseline and Months 3, 6, 9, and 12
measure: Percentage of Participants Achieving a PASI 75 Response
timeFrame: Baseline and Months 3, 6, 9, and 12
measure: Percentage of Participants Achieving a PASI 50 Response
timeFrame: Baseline and Months 3, 6, 9, and 12
measure: Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline and Month 12
measure: Change From Baseline in DLQI Score
timeFrame: Baseline and Months 3, 6, 9, and 12
measure: Associations Between General Improvement in Psoriasis With Improvement in Nail Psoriasis
timeFrame: Baseline and Month 12
measure: Associations Between General Improvement in Psoriasis With Improvement in Scalp Psoriasis
timeFrame: Baseline and Month 12
measure: Associations Between Improvement in Quality of Life With Improvement in Nail Psoriasis
timeFrame: Baseline and Month 12
measure: Associations Between Improvement in Quality of Life With Improvement in Scalp Psoriasis
timeFrame: Baseline and Month 12
measure: Associations Between General Improvement in Psoriasis With Improvement in Quality of Life
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Chotoviny
country: Czech Republic
facility: Site Reference ID/Investigator# 63776
city: Jihlava
country: Czech Republic
facility: Site Reference ID/Investigator# 58083
city: Klimkovice
country: Czech Republic
facility: Site Reference ID/Investigator# 56762
city: Klimkovice
country: Czech Republic
facility: Site Reference ID/Investigator# 56763
city: Kostelec nad Ohri
country: Czech Republic
facility: Site Reference ID/Investigator# 30742
city: Prague 10
country: Czech Republic
facility: Site Reference ID/Investigator# 54503
city: Prague 2
country: Czech Republic
facility: Site Reference ID/Investigator# 56542
city: Prague 8
country: Czech Republic
facility: Site Reference ID/Investigator# 58084
city: Tallinn
country: Estonia
facility: Site Reference ID/Investigator# 57562
city: Tallinn
country: Estonia
facility: Site Reference ID/Investigator# 57563
city: Tallinn
country: Estonia
facility: Site Reference ID/Investigator# 57564
city: Tartu
country: Estonia
facility: Site Reference ID/Investigator# 57567
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 30743
city: Debrecen
country: Hungary
facility: Site Reference ID/Investigator# 42506
city: Debrecen
country: Hungary
facility: Site Reference ID/Investigator# 42507
city: Debrecen
country: Hungary
facility: Site Reference ID/Investigator# 42508
city: Debrecen
country: Hungary
facility: Site Reference ID/Investigator# 42509
city: Debrecen
country: Hungary
facility: Site Reference ID/Investigator# 42510
city: Kaposvar
country: Hungary
facility: Site Reference ID/Investigator# 42514
city: Kecskemet
country: Hungary
facility: Site Reference ID/Investigator# 42515
city: Miskolc
country: Hungary
facility: Site Reference ID/Investigator# 42516
city: Pecs
country: Hungary
facility: Site Reference ID/Investigator# 42511
city: Pecs
country: Hungary
facility: Site Reference ID/Investigator# 42512
city: Pecs
country: Hungary
facility: Site Reference ID/Investigator# 42513
city: Pecs
country: Hungary
facility: Site Reference ID/Investigator# 44854
city: Szeged
country: Hungary
facility: Site Reference ID/Investigator# 42502
city: Szombathely
country: Hungary
facility: Site Reference ID/Investigator# 42517
city: Afula
country: Israel
facility: Site Reference ID/Investigator# 30744
city: Jerusalem
country: Israel
facility: Site Reference ID/Investigator# 49888
city: Petach Tiqwa
country: Israel
facility: Site Reference ID/Investigator# 49886
city: Ramat Gan
country: Israel
facility: Site Reference ID/Investigator# 49887
city: Tel Aviv
country: Israel
facility: Site Reference ID/Investigator# 51783
city: Alexandria
country: Romania
facility: Site Reference ID/Investigator# 46184
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 44580
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 44572
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 44575
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 44576
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 46185
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 44563
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 44564
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 44566
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 44567
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 44569
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 44571
city: Cluj-Napoca
country: Romania
facility: Site Reference ID/Investigator# 30745
city: Constanta
country: Romania
facility: Site Reference ID/Investigator# 44561
city: Constanta
country: Romania
facility: Site Reference ID/Investigator# 44562
city: Craiova
country: Romania
facility: Site Reference ID/Investigator# 44557
city: Craiova
country: Romania
facility: Site Reference ID/Investigator# 44558
city: Craiova
country: Romania
facility: Site Reference ID/Investigator# 44559
city: Craiova
country: Romania
facility: Site Reference ID/Investigator# 44560
city: Iasi
country: Romania
facility: Site Reference ID/Investigator# 44547
city: Iasi
country: Romania
facility: Site Reference ID/Investigator# 44548
city: Iasi
country: Romania
facility: Site Reference ID/Investigator# 44549
city: Oradea
country: Romania
facility: Site Reference ID/Investigator# 46183
city: Ploiesti
country: Romania
facility: Site Reference ID/Investigator# 44555
city: Reghin
country: Romania
facility: Site Reference ID/Investigator# 44554
city: Targu Mures
country: Romania
facility: Site Reference ID/Investigator# 44550
city: Banska Bystrica
country: Slovakia
facility: Site Reference ID/Investigator# 30746
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 42521
city: Kosice
country: Slovakia
facility: Site Reference ID/Investigator# 42519
city: Martin
country: Slovakia
facility: Site Reference ID/Investigator# 42522
city: Presov
country: Slovakia
facility: Site Reference ID/Investigator# 42518
city: Ljubljana
country: Slovenia
facility: Site Reference ID/Investigator# 30747
city: Ljubljana
country: Slovenia
facility: Site Reference ID/Investigator# 44544
city: Maribor
country: Slovenia
facility: Site Reference ID/Investigator# 44542
city: Sezana
country: Slovenia
facility: Site Reference ID/Investigator# 47702
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 64524
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 66642
city: Kharkiv
country: Ukraine
facility: Site Reference ID/Investigator# 62304
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 56699
city: Lviv
country: Ukraine
facility: Site Reference ID/Investigator# 55443
city: Lviv
country: Ukraine
facility: Site Reference ID/Investigator# 70493
Study officials:
affiliation: AbbVie
name: Jaka Brumen
role: STUDY_DIRECTOR
References: