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 January 2015 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborator:
Raffeiner GmbH
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01401452
First received: July 1, 2011
Last updated: January 26, 2015
Last verified: January 2015
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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: | 203 |
| 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:
- Patients age >= 18 years
- 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.
- 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)
- 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)
- Patient is willing to consent to data anonymous being collected and provided to Abbott.
- 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:
- Patients who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SPC) and Humira Pen® SPC.
- Patients participating in another study program or clinical trial.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401452
Contacts
| 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 |
Locations
| Austria | |
| Site Reference ID/Investigator# 103475 | Withdrawn |
| Feldkirch, Austria, 6807 | |
| Site Reference ID/Investigator# 67422 | Active, not recruiting |
| Graz, Austria, 8010 | |
| Site Reference ID/Investigator# 80173 | Active, not recruiting |
| Laakirchen, Austria, 4663 | |
| Site Reference ID/Investigator# 67426 | Active, not recruiting |
| St. Poelten, Austria, 3100 | |
| Site Reference ID/Investigator# 73313 | Withdrawn |
| Vienna, Austria, 1030 | |
| Site Reference ID/Investigator# 67423 | Active, not recruiting |
| Vienna, Austria, 1090 | |
| Site Reference ID/Investigator# 67424 | Active, not recruiting |
| Vienna, Austria, 1090 | |
| Site Reference ID/Investigator# 67425 | Active, not recruiting |
| Vienna, Austria, 1030 | |
| Site Reference ID/Investigator# 69663 | Active, not recruiting |
| Vienna, Austria, 1100 | |
| Site Reference ID/Investigator# 67428 | Withdrawn |
| Vienna, Austria, A-1030 | |
| Site Reference ID/Investigator# 49966 | Active, not recruiting |
| Wels, Austria, 4600 | |
| Site Reference ID/Investigator# 67427 | Active, not recruiting |
| Wiener Neustadt, Austria, 2700 | |
| Greece | |
| Site Reference ID/Investigator# 129915 | Recruiting |
| Athens, Greece, 11521 | |
| Principal Investigator: Site Reference ID/Investigator# 129915 | |
| Site Reference ID/Investigator# 104337 | Not yet recruiting |
| Athens, Greece, 12462 | |
| Principal Investigator: Site Reference ID/Investigator# 104337 | |
| Site Reference ID/Investigator# 104339 | Recruiting |
| Athens, Greece, 11525 | |
| Principal Investigator: Site Reference ID/Investigator# 104339 | |
| Site Reference ID/Investigator# 104341 | Not yet recruiting |
| Athens, Greece, 15123 | |
| Principal Investigator: Site Reference ID/Investigator# 104341 | |
| Site Reference ID/Investigator# 104595 | Recruiting |
| Athens, Greece, 16121 | |
| Principal Investigator: Site Reference ID/Investigator# 104595 | |
| Site Reference ID/Investigator# 104335 | Recruiting |
| Athens, Greece, 16121 | |
| Principal Investigator: Site Reference ID/Investigator# 104335 | |
| Site Reference ID/Investigator# 129916 | Recruiting |
| Athens, Greece, 10676 | |
| Principal Investigator: Site Reference ID/Investigator# 129916 | |
| Site Reference ID/Investigator# 104340 | Not yet recruiting |
| Chania, Crete, Greece, 73200 | |
| Principal Investigator: Site Reference ID/Investigator# 104340 | |
| Site Reference ID/Investigator# 116381 | Recruiting |
| Heraklion Crete, Greece, 71110 | |
| Principal Investigator: Site Reference ID/Investigator# 116381 | |
| Site Reference ID/Investigator# 104596 | Recruiting |
| Larissa, Greece, 41100 | |
| Principal Investigator: Site Reference ID/Investigator# 104596 | |
| Site Reference ID/Investigator# 104597 | Recruiting |
| Pireas, Greece, 18536 | |
| Principal Investigator: Site Reference ID/Investigator# 104597 | |
| Site Reference ID/Investigator# 104336 | Not yet recruiting |
| Thessaloniki, Greece, 54643 | |
| Principal Investigator: Site Reference ID/Investigator# 104336 | |
| Site Reference ID/Investigator# 104338 | Recruiting |
| Thessaloniki, Greece, 564 29 | |
| Principal Investigator: Site Reference ID/Investigator# 104338 | |
| Israel | |
| Site Reference ID/Investigator# 102740 | Not yet recruiting |
| Beer Sheba, Israel | |
| Principal Investigator: Site Reference ID/Investigator# 102740 | |
| Site Reference ID/Investigator# 102741 | Not yet recruiting |
| Haifa, Israel | |
| Principal Investigator: Site Reference ID/Investigator# 102741 | |
| Site Reference ID/Investigator# 102738 | Not yet recruiting |
| Jerusalem, Israel | |
| Principal Investigator: Site Reference ID/Investigator# 102738 | |
| Site Reference ID/Investigator# 102735 | Not yet recruiting |
| Kfar Saba, Israel | |
| Principal Investigator: Site Reference ID/Investigator# 102735 | |
| Site Reference ID/Investigator# 102742 | Not yet recruiting |
| Kiryat Bialik, Israel | |
| Principal Investigator: Site Reference ID/Investigator# 102742 | |
| Site Reference ID/Investigator# 102737 | Not yet recruiting |
| Netivot, Israel | |
| Principal Investigator: Site Reference ID/Investigator# 102737 | |
| Site Reference ID/Investigator# 102739 | Not yet recruiting |
| Petach Tikva, Israel | |
| Principal Investigator: Site Reference ID/Investigator# 102739 | |
| Site Reference ID/Investigator# 131666 | Not yet recruiting |
| Petach Tikva, Israel, 49100 | |
| Principal Investigator: Site Reference ID/Investigator# 131666 | |
| Site Reference ID/Investigator# 102736 | Not yet recruiting |
| Tel Aviv, Israel | |
| Principal Investigator: Site Reference ID/Investigator# 102736 | |
| Portugal | |
| Site Reference ID/Investigator# 102746 | Not yet recruiting |
| Braga, Portugal, 4710-243 | |
| Principal Investigator: Site Reference ID/Investigator# 102746 | |
| Site Reference ID/Investigator# 102756 | Not yet recruiting |
| Lisbon, Portugal, 1649-035 | |
| Principal Investigator: Site Reference ID/Investigator# 102756 | |
| Site Reference ID/Investigator# 102757 | Not yet recruiting |
| Lisbon, Portugal, 1169-050 | |
| Principal Investigator: Site Reference ID/Investigator# 102757 | |
| Site Reference ID/Investigator# 102758 | Not yet recruiting |
| Lisbon, Portugal, 1069-166 | |
| Principal Investigator: Site Reference ID/Investigator# 102758 | |
| Site Reference ID/Investigator# 102743 | Not yet recruiting |
| Porto, Portugal, 4200-319 | |
| Principal Investigator: Site Reference ID/Investigator# 102743 | |
| Site Reference ID/Investigator# 102744 | Not yet recruiting |
| Porto, Portugal, 4099-001 | |
| Principal Investigator: Site Reference ID/Investigator# 102744 | |
| Site Reference ID/Investigator# 102755 | Not yet recruiting |
| Santarem, Portugal, 2005-177 | |
| Principal Investigator: Site Reference ID/Investigator# 102755 | |
| Site Reference ID/Investigator# 102745 | Not yet recruiting |
| Vila Nova de Gaia, Portugal, 4400-129 | |
| Principal Investigator: Site Reference ID/Investigator# 102745 | |
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: | January 26, 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 |
ClinicalTrials.gov processed this record on March 01, 2015