Greek Study of the Quality of Life in Patients With Psoriasis Treated With Adalimumab

NCT01077128 | Completed Results

• 1 other identifier: P11-984
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 61

Brief Summary

Primary objective

• To evaluate the quality of life of Adalimumab treated patients over a period of 12 months Secondary objectives
• To evaluate the long-term efficacy of Adalimumab in patients with moderate to severe chronic plaque psoriasis as prescribed by the dermatologists in day-to-day clinical practice and in accordance with the terms of the European marketing authorization.
• To evaluate changes in patients quality of life according to treatment response over a 12-month period
• To observe and assess the long term use and safety of Adalimumab as prescribed by the dermatologist in a normal clinical setting and in accordance with the terms of the European marketing authorization.

Conditions

Psoriasis

Keywords

Psoriasis; Quality of life

Outcome Measures

Primary Outcomes (1)

• Mean Change of Dermatology Life Quality Index (DLQI) Scores

  DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.

  12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)

Secondary Outcomes (5)

• Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores

  12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)

• Mean Change in the Dermatology Life Quality Index (DLQI) Score by Physician's Global Assessment of Disease Severity (PGA) Response Groups and by Geographical Region

  12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)

• Percentage of Patients Reporting "No Problem" on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)

  12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)

• Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores

  12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)

• Assessment of Long Term Use and Safety of Adalimumab as Prescribed by the Dermatologist in a Normal Clinical Setting and in Accordance With the Terms of the European Marketing Authorization

  12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)

Study Arms (1)

Patients with psoriasis

All eligible patients with psoriasis treated with Adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with Adalimumab according to routine medical practice from hospital and private physicians.

You may qualify if:

• Patients with moderate to severe chronic plaque psoriasis who are newly prescribed Humira (adalimumab) therapy (have never been treated with adalimumab before) and for whom the treating physician has made the decision that they are eligible for treatment with adalimumab in accordance with the terms of the local marketing authorization
• Patients with moderate to severe chronic plaque psoriasis for whom Adalimumab is indicated and has been prescribed according to the current approved local SPC as long as the first administration of adalimumab is not older than two months and they have not had dose interruptions since the initiation of adalimumab, and the Investigator can provide all the needed source documentation including a completed DLQI questionnaire at the start of Adalimumab treatment.
• Patient age ≥ 18
• Patient is willing to consent to data being collected and provided to Abbott

You may not qualify if:

• Patients who meet contraindications as outlined in the latest version of the local approved SPC
• Patients who participate in another clinical/observational study
• Patients who are not willing to sign an Informed Consent Form

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (61)

Site Reference ID/Investigator# 43746

Agrinio, 301 00, Greece

Location

Site Reference ID/Investigator# 30197

Amaliáda, Greece

Location

Site Reference ID/Investigator# 30039

Argos, 21200, Greece

Location

Site Reference ID/Investigator# 29903

Argyroúpoli, Greece

Location

Site Reference ID/Investigator# 29819

Athens, 10673, Greece

Location

Site Reference ID/Investigator# 29949

Athens, 11526, Greece

Location

Site Reference ID/Investigator# 30804

Athens, 16121, Greece

Location

Site Reference ID/Investigator# 30806

Athens, 16121, Greece

Location

Site Reference ID/Investigator# 38324

Athens, 16121, Greece

Location

Site Reference ID/Investigator# 22385

Athens, Greece

Location

Site Reference ID/Investigator# 29826

Athens, Greece

Location

Site Reference ID/Investigator# 29966

Athens, Greece

Location

Site Reference ID/Investigator# 29991

Athens, Greece

Location

Site Reference ID/Investigator# 30106

Athens, Greece

Location

Site Reference ID/Investigator# 30107

Athens, Greece

Location

Site Reference ID/Investigator# 30181

Athens, Greece

Location

Site Reference ID/Investigator# 30470

Athens, Greece

Location

Site Reference ID/Investigator# 30086

Chania, Crete, 73136, Greece

Location

Site Reference ID/Investigator# 43744

Chania, Crete, Greece

Location

Site Reference ID/Investigator# 30794

Crete, 71409, Greece

Location

Site Reference ID/Investigator# 29937

Crete, Greece

Location

Site Reference ID/Investigator# 29959

Crete, Greece

Location

Site Reference ID/Investigator# 29969

Crete, Greece

Location

Site Reference ID/Investigator# 38334

Drama, Greece

Location

Site Reference ID/Investigator# 30801

Florina, 53100, Greece

Location

Site Reference ID/Investigator# 29919

Giannitsá, 58100, Greece

Location

Site Reference ID/Investigator# 30202

Giannitsá, Greece

Location

Site Reference ID/Investigator# 29970

Glyfada, 16675, Greece

Location

Site Reference ID/Investigator# 30013

Glyfada, 16675, Greece

Location

Site Reference ID/Investigator# 29823

Glyfada, Greece

Location

Site Reference ID/Investigator# 30193

Halandri, Greece

Location

Site Reference ID/Investigator# 30083

Kalamaria, Greece

Location

Site Reference ID/Investigator# 30143

Kallithea, 17672, Greece

Location

Site Reference ID/Investigator# 47262

Katerini, 60100, Greece

Location

Site Reference ID/Investigator# 38329

Keratsini, Greece

Location

Site Reference ID/Investigator# 30108

Kolonaki, 10675, Greece

Location

Site Reference ID/Investigator# 30009

Kosmos, Greece

Location

Site Reference ID/Investigator# 38323

Larissa, 41100, Greece

Location

Site Reference ID/Investigator# 38340

Larissa, Greece

Location

Site Reference ID/Investigator# 29822

Livadeia, Greece

Location

Site Reference ID/Investigator# 30180

Makri, Greece

Location

Site Reference ID/Investigator# 29834

Mytilene, Greece

Location

Site Reference ID/Investigator# 30469

Mytilene, Greece

Location

Site Reference ID/Investigator# 38326

N.Heraklion, Greece

Location

Site Reference ID/Investigator# 30032

Neapoli, Greece

Location

Site Reference ID/Investigator# 30104

Pagkráti, 11634, Greece

Location

Site Reference ID/Investigator# 29817

Pátrai, Greece

Location

Site Reference ID/Investigator# 29967

Peiraius, Greece

Location

Site Reference ID/Investigator# 38327

Peristeri, Greece

Location

Site Reference ID/Investigator# 30109

Petralona, Greece

Location

Site Reference ID/Investigator# 29824

Smyrni, Greece

Location

Site Reference ID/Investigator# 38325

Thessaloniki, 54643, Greece

Location

Site Reference ID/Investigator# 30769

Thessaloniki, 564 29, Greece

Location

Site Reference ID/Investigator# 30170

Thessaloniki, Greece

Location

Site Reference ID/Investigator# 38331

Thessaloniki, Greece

Location

Site Reference ID/Investigator# 38332

Thessaloniki, Greece

Location

Site Reference ID/Investigator# 38333

Thessaloniki, Greece

Location

Site Reference ID/Investigator# 38335

Thessaloniki, Greece

Location

Site Reference ID/Investigator# 38337

Thessaloniki, Greece

Location

Site Reference ID/Investigator# 30203

Vári, 16672, Greece

Location

Site Reference ID/Investigator# 29921

Volos, Greece

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Athina Katsavou, MD

  AbbVie Pharmaceuticals S.A.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: February 26, 2010
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 21, 2014
• Results First Posted: February 21, 2014

Record last verified: 2014-02

Locations

GR (61)