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Photographic Library of Moderate to Severe Psoriasis Subjects Treated With Infliximab (Study P05047) (PHODYPSO)

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ClinicalTrials.gov Identifier: NCT00749398
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : October 4, 2011
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Psoriasis
Intervention Biological: Infliximab
Enrollment 133
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Infliximab
Hide Arm/Group Description Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
Period Title: Overall Study
Started 124 [1]
Completed 71
Not Completed 53
Reason Not Completed
Lack of Efficacy             7
Adverse Event             4
Serious adverse event             11
Withdrawal by Subject             17
Lost to Follow-up             11
Reason not specified             2
Unknown reason             1
[1]
Nine participants were excluded because they did not fulfill the inclusion criteria.
Arm/Group Title Infliximab
Hide Arm/Group Description Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
Overall Number of Baseline Participants 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 124 participants
46.9  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants
Female
45
  36.3%
Male
79
  63.7%
1.Primary Outcome
Title Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists
Hide Description Digital pictures of each participant's whole body were taken at each visit. Static PGA was assessed by two dermatologists on the basis of these pictures at a single point in time. The mean of the two readings from the dermatologists was used. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.
Time Frame Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis.
Arm/Group Title Infliximab
Hide Arm/Group Description:
Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Visit 1 (n=117) 3.15  (1.02)
Visit 2 (n=102) 2.77  (0.98)
Visit 3 (n=96) 2.08  (1.01)
Visit 4 (n=86) 1.76  (0.95)
Visit 5 (n=69) 1.49  (0.86)
Visit 6 (n=67) 1.72  (1.04)
2.Primary Outcome
Title Dynamic Photographic PGA Score as Assessed by Two Dermatologists
Hide Description The dynamic PGA score resulted from the comparison of two sets of pictures/visits. The dynamic PGA was scored twice, at the middle and at the end of the observation period (comparison between picture sets of Week 0 (Visit 1) and Week 14 (Visit 4) visits and comparison between picture sets of Week 0 (Visit 1) and Week 30 (Visit 6) visits. Dynamic PGA was assessed by two dermatologists and the mean of the two readings was used. Clinical improvement was measured with a 10 centimeter (cm)-visual analogue scale (VAS) ranging from 0 (no improvement) to 10 (disappearance of lesions).
Time Frame Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis.
Arm/Group Title Infliximab
Hide Arm/Group Description:
Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Change between Visit 1 and Visit 4 (n=80) 7.05  (2.32)
Change between Visit 1 and Visit 6 (n=54) 7.7  (2.09)
3.Secondary Outcome
Title Static PGA Score as Assessed by the Investigator
Hide Description Static PGA was assessed at each visit by the investigator. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.
Time Frame Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis.
Arm/Group Title Infliximab
Hide Arm/Group Description:
Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Visit 1 (n=124) 3.84  (0.80)
Visit 2 (n=111) 3.21  (0.90)
Visit 3 (n=101) 2.27  (1.11)
Visit 4 (n=91) 1.92  (1.17)
Visit 5 (n=81) 1.72  (1.21)
Visit 6 (n=74) 2.03  (1.33)
4.Secondary Outcome
Title Dynamic PGA Score as Assessed by the Investigator
Hide Description The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits.
Time Frame Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis.
Arm/Group Title Infliximab
Hide Arm/Group Description:
Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Change between Visit 1 and Visit 4 (n=88) 7.27  (2.63)
Change between Visit 1 and Visit 6 (n=70) 7.28  (3.04)
5.Secondary Outcome
Title Percent Body Surface Area (BSA) Involved With Psoriasis
Hide Description [Not Specified]
Time Frame Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5),Week 30 (Visit 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis.
Arm/Group Title Infliximab
Hide Arm/Group Description:
Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: Percent BSA Involved with Psoriasis
Visit 1 (n=123) 42.33  (27.12)
Visit 2 (n=111) 34.86  (25.95)
Visit 3 (n=99) 22.95  (23.84)
Visit 4 (n=91) 16.86  (21.42)
Visit 5 (n=80) 10.84  (14.17)
Visit 6 (n=74) 14.12  (19.26)
6.Secondary Outcome
Title Psoriasis Area and Severity Index (PASI) Score
Hide Description PASI ranged from 0 (no symptoms) to 72 (very marked symptoms) and assessed 3 clinical signs within each area (head, arms, trunk, and legs): erythema (redness), induration (thickness), and desquamation (scaling).
Time Frame Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis.
Arm/Group Title Infliximab
Hide Arm/Group Description:
Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Visit 1 (n=124) 21.92  (15.02)
Visit 2 (n=109) 12.95  (10.23)
Visit 3 (n=101) 8.00  (8.83)
Visit 4 (n=90) 6.38  (7.60)
Visit 5 (n=81) 5.33  (6.41)
Visit 6 (n=74) 7.17  (8.92)
7.Secondary Outcome
Title Nail Psoriasis Severity Index (NAPSI) Score
Hide Description The nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail was evaluated, and the sum of all the nails was the total NAPSI score. The sum of the scores from all nails ranged from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Time Frame Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis.
Arm/Group Title Infliximab
Hide Arm/Group Description:
Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Visit 1 (n=86) 28.74  (23.19)
Visit 2 (n=75) 27.08  (23.35)
Visit 3 (n=70) 22.17  (21.95)
Visit 4 (n=64) 18.64  (19.95)
Visit 5 (n=53) 17.53  (20.83)
Visit 6 (n=52) 15.67  (17.59)
8.Secondary Outcome
Title Static PGA Score as Assessed by the Participant
Hide Description Participants assessed their psoriasis at Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), and Week 30 (Visit 6) according to the Static PGA score, which ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.
Time Frame Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis.
Arm/Group Title Infliximab
Hide Arm/Group Description:
Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Visit 1 (n=121) 4.02  (0.9)
Visit 2 (n=101) 3.35  (0.98)
Visit 3 (n=96) 2.5  (1.25)
Visit 4 (n=87) 2.24  (1.27)
Visit 5 (n=77) 1.9  (1.27)
Visit 6 (n=71) 2.2  (1.48)
9.Secondary Outcome
Title Dynamic PGA Score as Assessed by the Participant
Hide Description The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits.
Time Frame Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis.
Arm/Group Title Infliximab
Hide Arm/Group Description:
Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Change between Visit 1 and Visit 4 (n=80) 6.91  (2.57)
Change between Visit 1 and Visit 6 (n=70) 6.56  (3.32)
10.Secondary Outcome
Title Dermatology Life Quality Index (DLQI) Score
Hide Description DLQI ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life) and was computed by summing the score (each ranging from 0 to 3) of each of a 10-item questionnaire.
Time Frame Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis.
Arm/Group Title Infliximab
Hide Arm/Group Description:
Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Visit 1 (n=114) 13.55  (7.27)
Visit 2 (n=99) 8.75  (6.4)
Visit 3 (n=91) 5.46  (5.55)
Visit 4 (n=79) 4.89  (6.07)
Visit 5 (n=76) 4.18  (6.11)
Visit 6 (n=69) 5.39  (6.81)
11.Secondary Outcome
Title Number of Participants With Satisfactory Health Status
Hide Description Participant's opinion on his/her health status, as assessed by the following question: "Think about all the ways your psoriasis is affecting you, do you consider that your current status is satisfactory? (Yes/No)"
Time Frame Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis.
Arm/Group Title Infliximab
Hide Arm/Group Description:
Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: Participants
Visit 1 (n=118) 9
Visit 2 (n=98) 42
Visit 3 (n=94) 61
Visit 4 (n=83) 61
Visit 5 (n=77) 63
Visit 6 (n=68) 46
Time Frame [Not Specified]
Adverse Event Reporting Description All 133 participants enrolled in the study were included in the safety population.
 
Arm/Group Title Infliximab
Hide Arm/Group Description Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
All-Cause Mortality
Infliximab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Infliximab
Affected / at Risk (%) # Events
Total   17/133 (12.78%)    
Cardiac disorders   
Coronary artery disease  1/133 (0.75%)  1
Gastrointestinal disorders   
Diarrhoea  1/133 (0.75%)  1
Oral pruritus  1/133 (0.75%)  1
Palatal oedema  1/133 (0.75%)  1
General disorders   
General physical health deterioration  1/133 (0.75%)  1
Pyrexia  1/133 (0.75%)  1
Immune system disorders   
Anaphylactic reaction  1/133 (0.75%)  1
Infections and infestations   
Bronchitis  1/133 (0.75%)  1
Tuberculosis  1/133 (0.75%)  1
Investigations   
Tuberculosis test positive  1/133 (0.75%)  1
Weight decreased  1/133 (0.75%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  2/133 (1.50%)  2
Arthritis  1/133 (0.75%)  1
Nervous system disorders   
Paraesthesia  1/133 (0.75%)  1
Syncope vasovagal  1/133 (0.75%)  1
Renal and urinary disorders   
Polyuria  1/133 (0.75%)  1
Reproductive system and breast disorders   
Prostatitis  1/133 (0.75%)  1
Respiratory, thoracic and mediastinal disorders   
Lung disorder  1/133 (0.75%)  1
Respiratory failure  1/133 (0.75%)  1
Skin and subcutaneous tissue disorders   
Psoriasis  2/133 (1.50%)  2
Pustular psoriasis  1/133 (0.75%)  1
Urticaria  1/133 (0.75%)  1
1
Term from vocabulary, MedDRA (9.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infliximab
Affected / at Risk (%) # Events
Total   0/133 (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.
Prior to publication or presentation (abstract, poster, oral communication and any other support existing or future), a copy of the final text should be forwarded by the Investigator(s) to the sponsor, for comment and authorization. Such comments and authorization shall aim to ensure the scientific content of the proposed publication and/or presentations and shall ensure that data and the material referring to the sponsor activities receive fair, accurate, and reasonable presentation.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00749398     History of Changes
Other Study ID Numbers: P05047
First Submitted: September 5, 2008
First Posted: September 9, 2008
Results First Submitted: August 31, 2011
Results First Posted: October 4, 2011
Last Update Posted: July 28, 2015