Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

NCT01202565 | Completed Results

• 1 other identifier: P12-165
• Study Type: observational
• Target: 506
• Locations: 7 countries
• Sites: 69

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.

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®)

Outcome Measures

Primary Outcomes (2)

• Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12

  NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. 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 (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: * 0 = none; * 1 = present in 1/4 nail quadrants; * 2 = present in 2/4 nail quadrants; * 3 = present in 3/4 nail quadrants; * 4 = present in 4/4 nail quadrants. The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Month 12 value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.

  Baseline and Month 12

• Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to Month 12

  The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.

  Baseline and Month 12

Secondary Outcomes (18)

• Change From Baseline in Nail Psoriasis Severity Index (NAPSI)

  Baseline and Months 3, 6, 9, and 12

• Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis

  Baseline and Months 3, 6, 9, and 12

• Percentage of Participants Achieving Complete Clearing of Nails

  Months 3, 6, 9, and 12

• Change From Baseline in Psoriasis Scalp Severity Index (PSSI)

  Baseline and Months 3, 6, 9, and 12

• Percentage of Participants Achieving Good Clinical Response on Scalp

  Baseline and Months 3, 6, 9, and 12

Study Arms (1)

Adalimumab

Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients will be enrolled in this PMOS if they fulfill all of the below criteria:
• Patients with moderate to severe plaque psoriasis eligible for Humira therapy according to the local product label and prescription/reimbursement guidelines
• 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)
• Adult (≥18 years of age)
• Have negative result of tuberculosis (TB) screening test or TB prophylaxis as per local guidelines
• Willing to provide informed consent if requested by the local law regulations

You may not qualify if:

• Meet contraindications as outlined in the latest version of the local Summary of Product Characteristics (SmPC)
• Participate in another clinical/observational study

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (73)

Site Reference ID/Investigator# 63776

Chotoviny, 391 32, Czechia

Location

Site Reference ID/Investigator# 58083

Jihlava, 58601, Czechia

Location

Site Reference ID/Investigator# 56762

Klimkovice, 74283, Czechia

Location

Site Reference ID/Investigator# 56763

Klimkovice, 74283, Czechia

Location

Site Reference ID/Investigator# 30742

Kostelec nad Ohří, 517 41, Czechia

Location

Site Reference ID/Investigator# 54503

Prague, 100 34, Czechia

Location

Site Reference ID/Investigator# 56542

Prague, 128 08, Czechia

Location

Site Reference ID/Investigator# 58084

Prague, 18081, Czechia

Location

Site Reference ID/Investigator# 57562

Tallinn, 13419, Estonia

Location

Site Reference ID/Investigator# 57563

Tallinn, 13419, Estonia

Location

Site Reference ID/Investigator# 57564

Tallinn, 13419, Estonia

Location

Site Reference ID/Investigator# 57567

Tartu, 50406, Estonia

Location

Site Reference ID/Investigator# 30743

Budapest, 1085, Hungary

Location

Site Reference ID/Investigator# 42506

Debrecen, 4032, Hungary

Location

Site Reference ID/Investigator# 42507

Debrecen, 4032, Hungary

Location

Site Reference ID/Investigator# 42508

Debrecen, 4032, Hungary

Location

Site Reference ID/Investigator# 42509

Debrecen, 4032, Hungary

Location

Site Reference ID/Investigator# 42510

Debrecen, 4032, Hungary

Location

Site Reference ID/Investigator# 42514

Kaposvár, 7400, Hungary

Location

Site Reference ID/Investigator# 42515

Kecskemét, 6000, Hungary

Location

Site Reference ID/Investigator# 42516

Miskolc, 3529, Hungary

Location

Site Reference ID/Investigator# 42511

Pécs, 7624, Hungary

Location

Site Reference ID/Investigator# 42512

Pécs, 7624, Hungary

Location

Site Reference ID/Investigator# 42513

Pécs, 7624, Hungary

Location

Site Reference ID/Investigator# 44854

Pécs, 7624, Hungary

Location

Site Reference ID/Investigator# 42502

Szeged, 6720, Hungary

Location

Site Reference ID/Investigator# 42517

Szombathely, 9700, Hungary

Location

Site Reference ID/Investigator# 30744

Afula, 18101, Israel

Location

Site Reference ID/Investigator# 49888

Jerusalem, 9112001, Israel

Location

Site Reference ID/Investigator# 49886

Petach Tiqwa, 49100, Israel

Location

Site Reference ID/Investigator# 49887

Ramat Gan, 52621, Israel

Location

Site Reference ID/Investigator# 51783

Tel Aviv, 64239, Israel

Location

Site Reference ID/Investigator# 46184

Alexandria, 140074, Romania

Location

Site Reference ID/Investigator# 44580

Bucharest, 010825, Romania

Location

Site Reference ID/Investigator# 44572

Bucharest, 011461, Romania

Location

Site Reference ID/Investigator# 44575

Bucharest, 040215, Romania

Location

Site Reference ID/Investigator# 44576

Bucharest, 040215, Romania

Location

Site Reference ID/Investigator# 46185

Bucharest, 040215, Romania

Location

Site Reference ID/Investigator# 44563

Bucharest, 72202, Romania

Location

Site Reference ID/Investigator# 44564

Bucharest, 72202, Romania

Location

Site Reference ID/Investigator# 44566

Bucharest, 72202, Romania

Location

Site Reference ID/Investigator# 44567

Bucharest, 72202, Romania

Location

Site Reference ID/Investigator# 44569

Bucharest, 72202, Romania

Location

Site Reference ID/Investigator# 44571

Bucharest, 72202, Romania

Location

Site Reference ID/Investigator# 30745

Cluj-Napoca, 400006, Romania

Location

Site Reference ID/Investigator# 44561

Constanța, 900125, Romania

Location

Site Reference ID/Investigator# 44562

Constanța, 900125, Romania

Location

Site Reference ID/Investigator# 44557

Craiova, 200642, Romania

Location

Site Reference ID/Investigator# 44558

Craiova, 200642, Romania

Location

Site Reference ID/Investigator# 44559

Craiova, 200642, Romania

Location

Site Reference ID/Investigator# 44560

Craiova, 200642, Romania

Location

Site Reference ID/Investigator# 44547

Iași, 700368, Romania

Location

Site Reference ID/Investigator# 44548

Iași, 700368, Romania

Location

Site Reference ID/Investigator# 44549

Iași, 700506, Romania

Location

Site Reference ID/Investigator# 46183

Oradea, 410167, Romania

Location

Site Reference ID/Investigator# 44555

Ploieşti, 100379, Romania

Location

Site Reference ID/Investigator# 44554

Reghin, 545300, Romania

Location

Site Reference ID/Investigator# 44550

Târgu Mureş, 540136, Romania

Location

Site Reference ID/Investigator# 30746

Banská Bystrica, 975 17, Slovakia

Location

Site Reference ID/Investigator# 42521

Bratislava, 813 69, Slovakia

Location

Site Reference ID/Investigator# 42519

Košice, 040 66, Slovakia

Location

Site Reference ID/Investigator# 42522

Martin, 036 59, Slovakia

Location

Site Reference ID/Investigator# 42518

Prešov, 080 01, Slovakia

Location

Site Reference ID/Investigator# 30747

Ljubljana, 1000, Slovenia

Location

Site Reference ID/Investigator# 44544

Ljubljana, 1000, Slovenia

Location

Site Reference ID/Investigator# 44542

Maribor, 2000, Slovenia

Location

Site Reference ID/Investigator# 47702

Sežana, 6210, Slovenia

Location

Site Reference ID/Investigator# 64524

Donetsk, 83017, Ukraine

Location

Site Reference ID/Investigator# 66642

Donetsk, 83087, Ukraine

Location

Site Reference ID/Investigator# 62304

Kharkiv, 61036, Ukraine

Location

Site Reference ID/Investigator# 56699

Kiev, 04107, Ukraine

Location

Site Reference ID/Investigator# 55443

Lviv, 79015, Ukraine

Location

Site Reference ID/Investigator# 70493

Lviv, 79018, Ukraine

Location

Related Links

• Related Info

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Jaka Brumen

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 7, 2014
• Results First Posted: August 7, 2014

Record last verified: 2014-07

Locations

CZ (8); HU (15); IL (5); SL (5); RO (26); UA (6); ES (4)