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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01077128
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : February 21, 2014
Last Update Posted : February 21, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Time Perspective: Prospective
Condition Psoriasis
Enrollment 500
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients With Psoriasis
Hide Arm/Group Description All eligible patients with psoriasis treated with Adalimumab
Period Title: Overall Study
Started 500
Completed 433
Not Completed 67
Reason Not Completed
Adverse Event             8
Lack of Efficacy             1
Disease exacerbation             1
Adverse event and consent withdrawal             1
Adverse event and disease exacerbation             1
Lack of efficacy/disease exacerbation             1
Other             54
Arm/Group Title Patients With Psoriasis
Hide Arm/Group Description All eligible patients with psoriasis treated with Adalimumab
Overall Number of Baseline Participants 500
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
>=18 years Number Analyzed 500 participants
500
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants
Female
190
  38.0%
Male
310
  62.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Greece Number Analyzed 500 participants
500
Regions of Greece  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 500 participants
Attica 266
Central Macedonia 71
Crete 41
West Greece 33
East Macedonia and Thrace 20
Thessaly 18
Central Greece 16
Peloponnese 16
North Aegean 8
Ionian Islands 4
West Macedonia 3
South Aegean 2
Epirus 2
1.Primary Outcome
Title Mean Change of Dermatology Life Quality Index (DLQI) Scores
Hide Description 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.
Time Frame 12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at each time point
Arm/Group Title Patients With Psoriasis- Month 1 Patients With Psoriasis- Month 4 Patients With Psoriasis- Month 8 Patients With Psoriasis- Month 12
Hide Arm/Group Description:
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
Overall Number of Participants Analyzed 491 467 443 432
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.9  (6.3) 9.3  (7.3) 11.3  (7.8) 12.1  (7.8)
2.Secondary Outcome
Title Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores
Hide Description The Physician's Global Assessment of disease severity (PGA) was used to measure participants' disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores was recorded.
Time Frame 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at each time point
Arm/Group Title Patients With Psoriasis- Month 1 Patients With Psoriasis- Month 4 Patients With Psoriasis- Month 8 Patients With Psoriasis- Month 12
Hide Arm/Group Description:
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
Overall Number of Participants Analyzed 491 470 445 433
Measure Type: Number
Unit of Measure: Percentage of patients improving
66.2 95.1 97.5 97.9
3.Secondary Outcome
Title 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
Hide Description The average change in the Dermatology Life Quality Index (DLQI) score during the 12-month study was analyzed by the Physician's Global Assessment of disease severity (PGA) response and also by geographical location of study participants. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life. . In this table, a higher number means a greater improvement in the participants' quality of life.
Time Frame 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at each time point
Arm/Group Title DLQI Score Change by PGA Response Group- Month 1 DLQI Score Change by PGA Response Group- Month 4 DLQI Score Change by PGA Response Group- Month 8 DLQI Score Change by PGA Response Group- Month 12 DLQI Score Change Baseline to Month 12- Attica DLQI Score Change Baseline to Month 12- Central Greece DLQI Score Change Baseline to Month 12- Central Macedonia DLQI Score Change Baseline to Month 12- Crete DLQI Score Change Baseline to Month 12- East Macedonia/Thrace DLQI Score Change Baseline to Month 12- Epirus DLQI Score Change Baseline to Month 12- Ionian Islands DLQI Score Change Baseline to Month 12- North Aegean DLQI Score Change Baseline to Month 12- Peloponnese DLQI Score Change Baseline to Month 12- South Aegean DLQI Score Change Baseline to Month 12- Thessaly DLQI Score Change Baseline to Month 12- West Greece DLQI Score Change Baseline to Month 12- West Macedonia
Hide Arm/Group Description:
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
Overall Number of Participants Analyzed 325 444 433 423 237 16 65 34 20 2 1 7 10 2 15 21 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.3  (6.5) 9.6  (7.1) 11.5  (7.7) 12.3  (7.8) 12.9  (8.5) 14.9  (7.2) 12.3  (6.4) 11.2  (6.7) 10.6  (6.1) 2.0  (0.0) 19.0 11.0  (7.7) 6.8  (4.7) 15.0  (4.2) 9.5  (7.7) 8.7  (7.2) 12.5  (2.1)
4.Secondary Outcome
Title Percentage of Patients Reporting "No Problem" on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)
Hide Description

EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome.

It has two components:

  1. the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and
  2. the EQ-5D VAS. The EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either "problem" or "no problem" with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively.
Time Frame 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at each time point
Arm/Group Title EQ5D- Mobility- Baseline EQ5D- Mobility- Month 1 EQ5D- Mobility- Month 4 EQ5D- Mobility- Month 8 EQ5D- Mobility- Month 12 EQ5D- Self-care- Baseline EQ5D- Self-care- Month 1 EQ5D- Self-care- Month 4 EQ5D- Self-care- Month 8 EQ5D- Self-care- Month 12 EQ5D- Usual Activities- Baseline EQ5D- Usual Activities- Month 1 EQ5D- Usual Activities- Month 4 EQ5D- Usual Activities- Month 8 EQ5D- Usual Activities- Month 12 EQ5D- Pain/Discomfort- Baseline EQ5D- Pain/Discomfort- Month 1 EQ5D- Pain/Discomfort- Month 4 EQ5D- Pain/Discomfort- Month 8 EQ5D- Pain/Discomfort- Month 12 EQ5D- Anxiety/Depression- Baseline EQ5D- Anxiety/Depression- Month 1 EQ5D- Anxiety/Depression- Month 4 EQ5D- Anxiety/Depression- Month 8 EQ5D- Anxiety/Depression- Month 12
Hide Arm/Group Description:
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
Overall Number of Participants Analyzed 500 491 469 445 433 500 491 469 445 432 500 491 468 445 433 500 491 469 445 431 500 491 467 445 433
Measure Type: Number
Unit of Measure: Percentage of patients with no problem
74.6 66.2 90.2 91.5 90.8 81.2 84.3 92.1 95.3 94.2 66.2 77.8 90.2 92.1 94.5 56.2 73.1 87.2 90.3 93.3 20.8 36.9 53.7 67.6 73.0
5.Secondary Outcome
Title Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores
Hide Description

EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome.

It has two components:

  1. the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and
  2. the EQ-5D VAS. EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either "problem" or "no problem" with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively.
Time Frame 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at each time point
Arm/Group Title EQ-5D VAS- Mean Change From Baseline-Month 1 EQ-5D VAS- Mean Change From Baseline-Month 4 EQ-5D VAS- Mean Change From Baseline-Month 8 EQ-5D VAS- Mean Change From Baseline-Month 12
Hide Arm/Group Description:
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
All eligible patients with psoriasis treated with Adalimumab
Overall Number of Participants Analyzed 491 470 445 433
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.5  (15.8) 25.9  (20.5) 31.8  (23.3) 35.9  (22.4)
6.Secondary Outcome
Title 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
Hide Description An adverse event (AE) was defined as any untoward medical occurrence in a participant, which did not necessarily have a causal relationship with their treatment. Any worsening of a pre-existing condition or illness was considered an adverse event.
Time Frame 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Psoriasis
Hide Arm/Group Description:
All eligible patients with psoriasis treated with Adalimumab were followed for the long term use and safety of Adalimumab. For more detailed information, please see the Adverse Events section.
Overall Number of Participants Analyzed 500
Measure Type: Number
Unit of Measure: Participants
500
Time Frame Data on adverse events were collected from study enrollment (Month 0) through Month 12.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients With Psoriasis
Hide Arm/Group Description All eligible patients with psoriasis treated with Adalimumab
All-Cause Mortality
Patients With Psoriasis
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Patients With Psoriasis
Affected / at Risk (%)
Total   11/500 (2.20%) 
Blood and lymphatic system disorders   
Eosinophilia * 1  2/500 (0.40%) 
Anaemia * 1  1/500 (0.20%) 
Leukocytosis * 1  1/500 (0.20%) 
Lymphadenopathy * 1  1/500 (0.20%) 
Thrombocytosis * 1  1/500 (0.20%) 
Endocrine disorders   
Thyroiditis acute * 1  1/500 (0.20%) 
General disorders   
Asthenia * 1  2/500 (0.40%) 
Pyrexia * 1  2/500 (0.40%) 
Chills * 1  1/500 (0.20%) 
Fatigue * 1  1/500 (0.20%) 
Oedema, peripheral * 1  1/500 (0.20%) 
Hepatobiliary disorders   
Hepatosplenomegaly * 1  1/500 (0.20%) 
Infections and infestations   
Lower respiratory tract infection * 1  1/500 (0.20%) 
Injury, poisoning and procedural complications   
Road traffic accident * 1  1/500 (0.20%) 
Investigations   
Electromyogram abnormal * 1  1/500 (0.20%) 
Musculoskeletal and connective tissue disorders   
Muscle contractions involuntary * 1  1/500 (0.20%) 
Pain in extremity * 1  1/500 (0.20%) 
Rhabdomyolysis * 1  1/500 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Mycosis fungoides * 1  1/500 (0.20%) 
Nervous system disorders   
Dysarthria * 1  1/500 (0.20%) 
Extradural haematoma * 1  1/500 (0.20%) 
Hypoaesthesia * 1  1/500 (0.20%) 
Paraplegia * 1  1/500 (0.20%) 
Paresis * 1  1/500 (0.20%) 
Spinal cord ischaemia * 1  1/500 (0.20%) 
Spinal haematoma * 1  1/500 (0.20%) 
Pregnancy, puerperium and perinatal conditions   
Ectopic pregnancy * 1  1/500 (0.20%) 
Reproductive system and breast disorders   
Vaginal haemorrhage * 1  1/500 (0.20%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion * 1  1/500 (0.20%) 
Skin and subcutaneous tissue disorders   
Pruritus * 1  1/500 (0.20%) 
Pustular psoriasis * 1  1/500 (0.20%) 
Skin exfoliation * 1  1/500 (0.20%) 
Surgical and medical procedures   
Abortion induced * 1  1/500 (0.20%) 
Vascular disorders   
Ischaemic stroke * 1  2/500 (0.40%) 
Transient ischaemic attack * 1  1/500 (0.20%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Patients With Psoriasis
Affected / at Risk (%)
Total   0/500 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01077128    
Other Study ID Numbers: P11-984
First Submitted: February 25, 2010
First Posted: February 26, 2010
Results First Submitted: September 13, 2013
Results First Posted: February 21, 2014
Last Update Posted: February 21, 2014