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

This study is ongoing, but not recruiting participants.
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 27, 2015
Last verified: July 2015
  Purpose

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.


Condition
Moderate to Severe Plaque Psoriasis
Antibodies
Monoclonals

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 266
Study Start Date: August 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

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

Hospital, Dermatology

Criteria

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.
  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: NCT01401452

Locations
Austria
Site Reference ID/Investigator# 67422
Graz, Austria, 8010
Site Reference ID/Investigator# 80173
Laakirchen, Austria, 4663
Site Reference ID/Investigator# 67426
St. Poelten, Austria, 3100
Site Reference ID/Investigator# 67423
Vienna, Austria, 1090
Site Reference ID/Investigator# 67424
Vienna, Austria, 1090
Site Reference ID/Investigator# 67425
Vienna, Austria, 1030
Site Reference ID/Investigator# 69663
Vienna, Austria, 1100
Site Reference ID/Investigator# 49966
Wels, Austria, 4600
Site Reference ID/Investigator# 67427
Wiener Neustadt, Austria, 2700
Greece
Site Reference ID/Investigator# 104335
Athens, Greece, 16121
Site Reference ID/Investigator# 104337
Athens, Greece, 12462
Site Reference ID/Investigator# 104339
Athens, Greece, 11525
Site Reference ID/Investigator# 104595
Athens, Greece, 16121
Site Reference ID/Investigator# 129915
Athens, Greece, 11521
Site Reference ID/Investigator# 129916
Athens, Greece, 10676
Site Reference ID/Investigator# 116381
Heraklion Crete, Greece, 71110
Site Reference ID/Investigator# 104596
Larissa, Greece, 41100
Site Reference ID/Investigator# 104597
Pireas, Greece, 18536
Site Reference ID/Investigator# 104336
Thessaloniki, Greece, 54643
Site Reference ID/Investigator# 104338
Thessaloniki, Greece, 564 29
Israel
Site Reference ID/Investigator# 102741
Haifa, Israel
Site Reference ID/Investigator# 102735
Kfar Saba, Israel
Site Reference ID/Investigator# 102742
Kiryat Bialik, Israel
Site Reference ID/Investigator# 102737
Netivot, Israel
Site Reference ID/Investigator# 131666
Petah Tikva, Israel, 49100
Portugal
Site Reference ID/Investigator# 102746
Braga, Portugal, 4710-243
Site Reference ID/Investigator# 102756
Lisbon, Portugal, 1649-035
Site Reference ID/Investigator# 102757
Lisbon, Portugal, 1169-050
Site Reference ID/Investigator# 102758
Lisbon, Portugal, 1069-166
Site Reference ID/Investigator# 102743
Porto, Portugal, 4200-319
Site Reference ID/Investigator# 102744
Porto, Portugal, 4099-001
Site Reference ID/Investigator# 102755
Santarem, Portugal, 2005-177
Site Reference ID/Investigator# 102745
Vila Nova de Gaia, Portugal, 4400-129
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Raffeiner GmbH
Investigators
Study Director: Astrid Dworan-Timler, MD AbbVie Austria
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01401452     History of Changes
Other Study ID Numbers: P12-770
Study First Received: July 1, 2011
Last Updated: July 27, 2015
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by AbbVie:
Co-morbidities
Antibodies
Disease Life Quality Index (DLQI)
Adalimumab
Monoclonals
Moderate to severe plaque psoriasis
Psoriasis Area & Severity Index (PASI)
Biological disease modifying anti-rheumatic drugs (BDMARD)

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

ClinicalTrials.gov processed this record on September 03, 2015