Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

246 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-05-31

Brief Summary

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This multicenter, post marketing observational study (PMOS) was designed to evaluate the effectiveness of adalimumab over a period of 9 months as determined by the Psoriasis Area and Severity Index (PASI) in participants with moderate to severe plaque psoriasis with distinct co-morbidities. Secondary objectives of this study were to measure changes in psychological health via the Dermatology Life Quality Index (DLQI); changes in comorbidities with respect to gender; changes in quality of life using the Short Form Health Survey (SF-36); and evaluation of Minimal Clinically Important Differences (MCID).

Detailed Description

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Male or female participants ages 18 years of age and older for whom the treating physician had recently prescribed adalimumab were included in this study. Adalimumab was prescribed in accordance with the terms of the local marketing authorization with regards to dose, population, and indication. There were 5 planned visits during the study: baseline (Visit 1), 1 month (Visit 2), 3 months (Visit 3), 6 months (Visit 4), and 9 months (Visit 5).

Conditions

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Moderate to Severe Plaque Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with psoriasis and at least one co-morbid disease

Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Participants for whom adalimumab therapy is indicated and has been prescribed according to the product label and who meet the following criteria:

* Participant age ≥ 18 years
* Participants with moderate to severe plaque psoriasis participants who have at last one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression (diagnosed by a medical specialist for psychology, neurology, or psychiatry)
* Adalimumab naïve participants with moderate to severe plaque psoriasis after unsatisfactory response, non tolerability, or contraindication of systemic therapies such as ciclosporin, methotrexate or PUVA ( psoralen + UVA) or after biological disease modifying anti-rheumatic drugs (bDMARDs) failure (e.g.: infliximab, etanercept or ustekinumab)
* Participants of each country must fulfill any local treatment recommendation for use of bDMARD in psoriasis in their respective country. For Austria: participants must fulfill Austrian Treatment Recommendations for use of bDMARD in psoriasis (Chest X-ray and IGRA\* interferon gamma release assay or PPD-skin test negative for tuberculosis)
* Participant is willing to give informed consent to anonymous data collection and their forwarding to AbbVie as well as to informed consent if required in different countries.
* Participant must be able and willing to self-administer adalimumab injections or have a qualified person available to administer Humira® syringe or Humira® Pen injections

Exclusion Criteria

The following participants will not be included in this observational study:

* Participants who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SPC) and Humira Pen® SPC
* Participants participating in another study program or clinical trial
* Participants who have been treated with Humira® before

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc

Role: STUDY_DIRECTOR

AbbVie

Other Identifiers

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P12-770

Identifier Type: -

Identifier Source: org_study_id