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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Collaborator:
Raffeiner GmbH
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01401452
First received: July 1, 2011
Last updated: July 21, 2014
Last verified: July 2014

July 1, 2011
July 21, 2014
August 2011
September 2015   (final data collection date for primary outcome measure)
  • To evaluate the effectiveness of Adalimumab over a period of 9 month by analyzing the Psoriasis Area & Severity Index (PASI) in moderate to severe Plaque Psoriasis patients with distinct co-morbidities [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  • Psoriasis Area & Severity Index (PASI) (=Inclusion visit) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Observation and assessment for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination.
  • Psoriasis Area & Severity Index (PASI) [ Time Frame: month 1 ] [ Designated as safety issue: No ]
    Observation and assessment for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination.
  • Psoriasis Area & Severity Index (PASI) [ Time Frame: month 3 ] [ Designated as safety issue: No ]
    Observation and assessment for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination.
  • Psoriasis Area & Severity Index (PASI) [ Time Frame: month 6 ] [ Designated as safety issue: No ]
    Observation and assessment for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination.
  • Psoriasis Area & Severity Index (PASI) [ Time Frame: month 9 ] [ Designated as safety issue: No ]
    Observation and assessment for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination.
Same as current
Complete list of historical versions of study NCT01401452 on ClinicalTrials.gov Archive Site
  • Dermatology Life Quality Index (DLQI) (=Inclusion visit) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Subjects will complete a DLQI questionnaire at study visits.
  • Dermatology Life Quality Index (DLQI) Subjects will complete a DLQI questionnaire at study visits. [ Time Frame: month 1 ] [ Designated as safety issue: No ]
    Subjects will complete a DLQI questionnaire at study visits.
  • Dermatology Life Quality Index (DLQI) Subjects will complete a DLQI questionnaire at study visits. [ Time Frame: month 3 ] [ Designated as safety issue: No ]
    Subjects will complete a DLQI questionnaire at study visits.
  • Dermatology Life Quality Index (DLQI) Subjects will complete a DLQI questionnaire at study visits. [ Time Frame: month 6 ] [ Designated as safety issue: No ]
    Subjects will complete a DLQI questionnaire at study visits.
  • Dermatology Life Quality Index (DLQI) Subjects will complete a DLQI questionnaire at study visits. [ Time Frame: month 9 ] [ Designated as safety issue: No ]
    Subjects will complete a DLQI questionnaire at study visits.
  • Evaluation of the prevalence of co-morbidities in consideration of gender (=Inclusion visit) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Life Quality (=Inclusion visit) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Evaluation of parameters of Life Quality (SF-36) and the Life-Quality for specific co-morbidities (optional)
  • Life Quality [ Time Frame: month 1 ] [ Designated as safety issue: No ]
    Evaluation of parameters of Life Quality (SF-36) and the Life-Quality for specific co-morbidities (optional)
  • Life Quality [ Time Frame: month 3 ] [ Designated as safety issue: No ]
    Evaluation of parameters of Life Quality (SF-36) and the Life-Quality for specific co-morbidities (optional)
  • Life Quality [ Time Frame: month 6 ] [ Designated as safety issue: No ]
    Evaluation of parameters of Life Quality (SF-36) and the Life-Quality for specific co-morbidities (optional)
  • Life Quality [ Time Frame: month 9 ] [ Designated as safety issue: No ]
    Evaluation of parameters of Life Quality (SF-36) and the Life-Quality for specific co-morbidities (optional)
  • Evaluation of the minimum of clinical important differences (MCID) (=Inclusion visit) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Evaluation of the minimum of clinical important differences (MCID) [ Time Frame: month 1 ] [ Designated as safety issue: No ]
  • Evaluation of the minimum of clinical important differences (MCID) [ Time Frame: month 3 ] [ Designated as safety issue: No ]
  • Evaluation of the minimum of clinical important differences (MCID) [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Evaluation of the minimum of clinical important differences (MCID) [ Time Frame: month 9 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities
Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities

The aim of this post-marketing observational study (PMOS) is the assessment of effectiveness of Adalimumab in moderate to severe Plaque Psoriasis patients with distinct co-morbidities and impact of Adalimumab on the quality of life in routine clinical praxis over the period of 9 month. Psoriasis is associated with several co-morbidities such as depression, obesity and metabolic syndrome. Until now it is unclear if these co-morbidities are due to the pathophysiology of psoriasis or psoriasis-associated behaviors (e.g. smoking and alcohol abuse). Disease severity is correlated with smoking and alcohol abuse. The severity of psoriasis shall be established before and under treatment of Adalimumab by calculation of the Psoriasis Area Severity Index (PASI) and the analysis of Dermatology Life Quality Index (DLQI) in Patients with at last one co-morbid disease and/or symptom. Also the prevalence of co-morbidities in consideration of gender and other parameters of Life Quality (SF-36) and Life-Quality for specific co-morbidities should be evaluated.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Hospital, Dermatology

  • Moderate to Severe Plaque Psoriasis
  • Antibodies
  • Monoclonals
Not Provided
Patients with psoriasis with at last one co-morbid disease
Patients with moderate to severe plaque psoriasis with at last one co-morbid disease and/or symptom such as hypertension, Psoriasis Arthritis confirmed by a rheumatologist, obesity, diabetes, metabolic syndrome or depression
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
266
September 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

  1. Patients age >= 18 years
  2. Moderate to severe Plaque Psoriasis patients with at last one co-morbid disease and/or symptom such as hypertension, Psoriasis Arthritis confirmed by a rheumatologist, obesity, diabetes, metabolic syndrome or depression.
  3. Adalimumab naïve patients with moderate to severe Plaque Psoriasis after unsatisfactory response or 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)
  4. Patients 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)
  5. Patient is willing to consent to data anonymous being collected and provided to Abbott.
  6. Patient 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 patients will not be included in this observational study:

  1. Patients who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SPC) and Humira Pen® SPC.
  2. Patients participating in another study program or clinical trial.
  3. Patients who have been treated with Humira® before.
Both
18 Years and older
No
Contact: Michaela Mayrhofer-Iro +43-1-20-589-382 michaela.mayrhofer-iro@abbvie.com
Contact: Astrid Dworan-Timler, MD +43-1-89-122-391 astrid.dworan-timler@abbvie.com
Austria,   Greece,   Israel,   Portugal
 
NCT01401452
P12-770
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Raffeiner GmbH
Study Director: Astrid Dworan-Timler, MD AbbVie Austria
AbbVie
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP