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Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Dermatologists

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ClinicalTrials.gov Identifier: NCT00293709
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : February 26, 2014
Last Update Posted : February 26, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Arthritis, Psoriatic
Psoriasis
Skin Diseases, Papulosquamous
Intervention Drug: etanercept
Enrollment 129
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Period Title: Overall Study
Started 149
Completed 102
Not Completed 47
Reason Not Completed
Other             47
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Baseline Participants 149
Hide Baseline Analysis Population Description
Safety analysis set included all participants who were enrolled in this study. Out of a total of 149 participants, data for baseline measure (age) was available only for 146 participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 149 participants
50.0  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants
Female
70
  47.0%
Male
79
  53.0%
1.Primary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in this study.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 149
Measure Type: Number
Unit of Measure: percentage of participants
AEs 24.2
SAEs 1.3
2.Secondary Outcome
Title Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52
Hide Description [Not Specified]
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were greater than (>) 18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 146
Mean (Standard Deviation)
Unit of Measure: percentage of BSA
Baseline (n=146) 24.5  (22.6)
Change at Week 52 (n=99) -17.8  (19.6)
3.Secondary Outcome
Title Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 52
Hide Description PASI: combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections (head, arms, trunk, and legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI=sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4; total score ranged from 0 (no disease) to 72 (maximal disease).
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 143
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=143) 15.1  (12.7)
Change at Week 52 (n=93) -11.8  (11.6)
4.Secondary Outcome
Title Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52
Hide Description DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate disease activity and >5.1 = high disease activity.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=68) 5.1  (1.4)
Change at Week 52 (n=43) -2.2  (1.7)
5.Secondary Outcome
Title Change From Baseline in Ritchie Index at Week 52
Hide Description Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant's reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 146
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=146) 15.8  (12.8)
Change at Week 52 (n=95) -3.6  (20.4)
6.Secondary Outcome
Title Change From Baseline in Physician Global Assessment of Disease Activity at Week 52
Hide Description Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 148
Mean (Standard Deviation)
Unit of Measure: millimeter
Baseline (n=148) 60.4  (22.3)
Change at Week 52 (n=102) -35.8  (31.4)
7.Secondary Outcome
Title Number of Participants With Nail Involvement
Hide Description Number of participants with psoriatic arthritis affecting the nails are reported.
Time Frame Baseline, Week 12, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 147
Measure Type: Number
Unit of Measure: participants
Baseline (n=147) 103
Week 12 (n=131) 81
Week 52 (n=100) 50
8.Secondary Outcome
Title Change From Baseline in C-reactive Protein (CRP) at Week 52
Hide Description The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: milligram per deciliter (mg/dL)
Baseline (n=115) 1.6  (3.0)
Change at Week 52 (n=69) -0.6  (3.5)
9.Secondary Outcome
Title Change From Baseline in Patient Assessment of Itching at Week 52
Hide Description Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 147
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=147) 44.0  (29.2)
Change at Week 52 (n=98) -26.1  (34.2)
10.Secondary Outcome
Title Change From Baseline in Patient Assessment of Pain at Week 52
Hide Description Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 147
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=147) 60.0  (27.1)
Change at Week 52 (n=98) -37.5  (33.8)
11.Secondary Outcome
Title Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52
Hide Description SF-12 questionnaire was used to determine participants' quality of life (QoL). It comprised 12 items which covered 8 concepts : physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: Physical component (n=142) 33.5  (9.2)
Baseline: Mental component (n=142) 40.5  (11.5)
Change at Week 52: Physical component (n=89) 11.7  (10.3)
Change at Week 52: Mental component (n=89) 9.4  (11.9)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
All-Cause Mortality
Participants With Psoriatic Arthritis
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Participants With Psoriatic Arthritis
Affected / at Risk (%)
Total   2/149 (1.34%) 
Gastrointestinal disorders   
Pancreatitis * 1  1/149 (0.67%) 
Hepatobiliary disorders   
Gallbladder pain * 1  1/149 (0.67%) 
Infections and infestations   
Pleural infection * 1  1/149 (0.67%) 
Pneumonia * 1  1/149 (0.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Malignant ascites * 1  1/149 (0.67%) 
Malignant pleural effusion * 1  1/149 (0.67%) 
Ovarian cancer * 1  1/149 (0.67%) 
Respiratory, thoracic and mediastinal disorders   
Pleurisy * 1  1/149 (0.67%) 
Pneumothorax * 1  1/149 (0.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants With Psoriatic Arthritis
Affected / at Risk (%)
Total   34/149 (22.82%) 
Cardiac disorders   
Coronary artery disease * 1  1/149 (0.67%) 
Eye disorders   
Eye pain * 1  2/149 (1.34%) 
Gastrointestinal disorders   
Abdominal distension * 1  1/149 (0.67%) 
Diarrhoea * 1  2/149 (1.34%) 
Nausea * 1  3/149 (2.01%) 
Stomach discomfort * 1  1/149 (0.67%) 
Vomiting * 1  2/149 (1.34%) 
General disorders   
Chest pain * 1  2/149 (1.34%) 
Condition aggravated * 1  1/149 (0.67%) 
Fatigue * 1  1/149 (0.67%) 
Influenza like illness * 1  1/149 (0.67%) 
Injection site erythema * 1  2/149 (1.34%) 
Injection site inflammation * 1  1/149 (0.67%) 
Injection site pruritus * 1  2/149 (1.34%) 
Injection site reaction * 1  1/149 (0.67%) 
Malaise * 1  1/149 (0.67%) 
Oedema peripheral * 1  2/149 (1.34%) 
Infections and infestations   
Bacteraemia * 1  1/149 (0.67%) 
Bronchitis * 1  1/149 (0.67%) 
Cystitis * 1  2/149 (1.34%) 
Genital herpes * 1  1/149 (0.67%) 
Herpes virus infection * 1  1/149 (0.67%) 
Infection * 1  2/149 (1.34%) 
Nasopharyngitis * 1  8/149 (5.37%) 
Oral herpes * 1  2/149 (1.34%) 
Rhinitis * 1  1/149 (0.67%) 
Sinobronchitis * 1  1/149 (0.67%) 
Sinusitis * 1  1/149 (0.67%) 
Tinea versicolour * 1  1/149 (0.67%) 
Tonsillitis * 1  1/149 (0.67%) 
Tooth abscess * 1  1/149 (0.67%) 
Upper respiratory tract infection * 1  3/149 (2.01%) 
Injury, poisoning and procedural complications   
Contusion * 1  1/149 (0.67%) 
Limb crushing injury * 1  1/149 (0.67%) 
Investigations   
Alanine aminotransferase * 1  1/149 (0.67%) 
Arthroscopy * 1  1/149 (0.67%) 
Platelet count decreased * 1  1/149 (0.67%) 
Serum ferritin decreased * 1  1/149 (0.67%) 
Transaminases increased * 1  1/149 (0.67%) 
Weight increased * 1  1/149 (0.67%) 
Metabolism and nutrition disorders   
Haemochromatosis * 1  1/149 (0.67%) 
Increased appetite * 1  1/149 (0.67%) 
Musculoskeletal and connective tissue disorders   
Limb discomfort * 1  1/149 (0.67%) 
Muscular weakness * 1  1/149 (0.67%) 
Musculoskeletal discomfort * 1  1/149 (0.67%) 
Myalgia * 1  1/149 (0.67%) 
Pain in extremity * 1  2/149 (1.34%) 
Psoriatic arthropathy * 1  1/149 (0.67%) 
Nervous system disorders   
Burning sensation * 1  1/149 (0.67%) 
Dizziness * 1  1/149 (0.67%) 
Headache * 1  2/149 (1.34%) 
Migraine * 1  1/149 (0.67%) 
Paraesthesia * 1  2/149 (1.34%) 
Psychiatric disorders   
Alcoholism * 1  1/149 (0.67%) 
Anxiety * 1  1/149 (0.67%) 
Depression * 1  1/149 (0.67%) 
Reproductive system and breast disorders   
Erectile dysfunction * 1  1/149 (0.67%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/149 (2.01%) 
Dyspnoea * 1  1/149 (0.67%) 
Dyspnoea exertional * 1  1/149 (0.67%) 
Hypoventilation * 1  1/149 (0.67%) 
Pharyngolaryngeal pain * 1  1/149 (0.67%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  2/149 (1.34%) 
Erythema * 1  3/149 (2.01%) 
Pruritus * 1  1/149 (0.67%) 
Rash * 1  1/149 (0.67%) 
Skin tightness * 1  1/149 (0.67%) 
Swelling face * 1  1/149 (0.67%) 
Urticaria * 1  1/149 (0.67%) 
Surgical and medical procedures   
Ligament operation * 1  1/149 (0.67%) 
Tonsillectomy * 1  1/149 (0.67%) 
Transurethral prostatectomy * 1  1/149 (0.67%) 
Vascular disorders   
Blood pressure fluctuation * 1  1/149 (0.67%) 
Hot flush * 1  1/149 (0.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v10.0
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00293709    
Other Study ID Numbers: 0881A6-102036
B1801126
First Submitted: February 15, 2006
First Posted: February 17, 2006
Results First Submitted: January 10, 2014
Results First Posted: February 26, 2014
Last Update Posted: February 26, 2014