Status:
COMPLETED
Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Raffeiner GmbH
Conditions:
Moderate to Severe Plaque Psoriasis
Eligibility:
All Genders
18+ years
Brief Summary
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 (P...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT01401452
Start Date
August 1 2011
End Date
May 1 2016
Last Update
October 4 2017
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