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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01202565
First received: September 14, 2010
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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 post-marketing observational study (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. As nails are not included in the general measures of disease severity (such as Psoriasis Area and Severity Index PASI), a nail specific tool 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. Psoriasis Area and Severity Index PASI), represents only 4-5 % of the body surface by the rule of 9 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 response to adalimumab therapy will also be examined.

Further, changes in patients' quality of life with reference to the adalimumab treatment response in general, on nails and scalp will be assessed.


Condition
Moderate to Severe Plaque Psoriasis

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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: baseline ] [ Designated as safety issue: No ]
  • 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: 3 months ] [ Designated as safety issue: No ]
  • 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: 6 months ] [ Designated as safety issue: No ]
  • 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: 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nail affection: Change in mean Nail Psoriasis Severity Index (NAPSI) score from baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Nail affection: Change in mean Nail Psoriasis Severity Index (NAPSI) score from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Nail affection: Change in mean Nail Psoriasis Severity Index (NAPSI) score from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Nail affection: Change in mean Nail Psoriasis Severity Index (NAPSI) score from baseline [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Nail affection: Change in mean Nail Psoriasis Severity Index (NAPSI) score from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Nail affection: Percentage (%) of patients achieving complete clearing of nails ( Nail Psoriasis Severity Index NAPSI 0) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Nail affection: Percentage (%) of patients achieving complete clearing of nails ( Nail Psoriasis Severity Index NAPSI 0) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Nail affection: Percentage (%) of patients achieving complete clearing of nails ( Nail Psoriasis Severity Index NAPSI 0) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Nail affection: Percentage (%) of patients achieving complete clearing of nails ( Nail Psoriasis Severity Index NAPSI 0) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Nail affection: Percentage (%) of patients achieving complete clearing of nails ( Nail Psoriasis Severity Index NAPSI 0) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Scalp affection: Change in mean Psoriasis Scalp Severity Index (PSSI) score from baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Scalp affection: Change in mean Psoriasis Scalp Severity Index (PSSI) score from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Scalp affection: Change in mean Psoriasis Scalp Severity Index (PSSI) score from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Scalp affection: Change in mean Psoriasis Scalp Severity Index (PSSI) score from baseline [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Scalp affection: Change in mean Psoriasis Scalp Severity Index (PSSI) score from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Scalp affection: Percentage (%) of patients achieving complete clearing of scalp (Psoriasis Scalp Severity Index PSSI 0) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Scalp affection: Percentage (%) of patients achieving complete clearing of scalp (Psoriasis Scalp Severity Index PSSI 0) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Scalp affection: Percentage (%) of patients achieving complete clearing of scalp (Psoriasis Scalp Severity Index PSSI 0) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Scalp affection: Percentage (%) of patients achieving complete clearing of scalp (Psoriasis Scalp Severity Index PSSI 0) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Scalp affection: Percentage (%) of patients achieving complete clearing of scalp (Psoriasis Scalp Severity Index PSSI 0) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • All patients: Mean percent improvement in Psoriasis Area and Severity Index (PASI) score from baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • All patients: Mean percent improvement in Psoriasis Area and Severity Index (PASI) score from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • All patients: Mean percent improvement in Psoriasis Area and Severity Index (PASI) score from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • All patients: Mean percent improvement in Psoriasis Area and Severity Index (PASI) score from baseline [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • All patients: Mean percent improvement in Psoriasis Area and Severity Index (PASI) score from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • All patients: Change in mean Psoriasis Area and Severity Index (PASI) score from baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • All patients: Change in mean Psoriasis Area and Severity Index (PASI) score from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • All patients: Change in mean Psoriasis Area and Severity Index (PASI) score from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • All patients: Change in mean Psoriasis Area and Severity Index (PASI) score from baseline [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • All patients: Change in mean Psoriasis Area and Severity Index (PASI) score from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • All patients: Percentage (%) of patients achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 and PASI 90 response) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • All patients: Percentage (%) of patients achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 and PASI 90 response) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • All patients: Percentage (%) of patients achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 and PASI 90 response) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • All patients: Percentage (%) of patients achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 and PASI 90 response) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • All patients: Percentage (%) of patients achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 and PASI 90 response) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • All patients: Mean percent improvement in Dermatology Life Quality Index (DLQI) score [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • All patients: Mean percent improvement in Dermatology Life Quality Index (DLQI) score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • All patients: Mean percent improvement in Dermatology Life Quality Index (DLQI) score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • All patients: Mean percent improvement in Dermatology Life Quality Index (DLQI) score [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • All patients: Mean percent improvement in Dermatology Life Quality Index (DLQI) score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • All patients: Change in Dermatology Life Quality Index (DLQI) score from baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • All patients: Change in Dermatology Life Quality Index (DLQI) score from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • All patients: Change in Dermatology Life Quality Index (DLQI) score from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • All patients: Change in Dermatology Life Quality Index (DLQI) score from baseline [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • All patients: Change in Dermatology Life Quality Index (DLQI) score from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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: baseline ] [ Designated as safety issue: No ]
  • 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: 3 months ] [ Designated as safety issue: No ]
  • 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: 6 months ] [ Designated as safety issue: No ]
  • 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: 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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: baseline ] [ Designated as safety issue: No ]
  • 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: 3 months ] [ Designated as safety issue: No ]
  • 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: 6 months ] [ Designated as safety issue: No ]
  • 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: 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 505
Study Start Date: September 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Single patients group
Single patients group with: moderate to severe plaque psoriasis

Detailed Description:

This post-marketing observational study PMOS will be conducted in a prospective, single-arm, multicountry, multicenter format.

As this study is observational in nature, the follow-up visits are not interventional and strictly scheduled, but rather left to the judgment of each investigator within the 12-month study period for each patient.

To optimize data collection, five (5) patient's visits are indicated within the 12-month observational period:

  • Visit 0 (V0): Baseline
  • Visit 1 (V1): Follow-up at 3 months
  • Visit 2 (V2): Follow-up at 6 months
  • Visit 3 (V3): Follow-up at 9 months
  • Visit 4 (V4): Follow-up at 12 months (Study End).

Humira ® is not supplied by Abbvie. The investigator is free to initiate or continue any concomitant medication as deemed clinically necessary. All treatments must be prescribed in accordance with their respective Marketing Authorization and local guidelines. Special attention must be paid to potential drug interactions as per the relevant Summary of Product Characteristics (SmPCs).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This is a 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.

Per this post- marketing observational study (PMOS) protocol, 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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202565

  Show 72 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Maja Hojnik AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01202565     History of Changes
Other Study ID Numbers: P12-165
Study First Received: September 14, 2010
Last Updated: July 23, 2013
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Romania: Ethics Committee
Hungary: Research Ethics Medical Committee
Ukraine: State Pharmacological Center - Ministry of Health
Slovenia: Agency for Medicinal Products - Ministry of Health
Slovenia: Ethics Committee
Estonia: The State Agency of Medicine
Czech Republic: State Institute for Drug Control
Slovak Republic: Ethics Committee

Keywords provided by AbbVie:
Post-marketing observational study (PMOS) Protocol
Moderate to Severe Plaque Psoriasis
Treatment of Scalp and Nail Affection
Effectiveness of Adalimumab (HUMIRA®)

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 23, 2014