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

Psoriasis Clinical Trial

— PHODYPSO  

Official title:

Atlas of the Evolution of Psoriasis Lesions Under Remicade® : A Dynamic Standardized Photographic Library of Moderate to Severe Psoriasis Subjects Treated With Infliximab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749398
• Other study ID #: P05047
• Status: Completed
• Phase: N/A
• First received: September 5, 2008
• Last updated: July 15, 2015
• Start date: September 2007
• Est. completion date: September 2010

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Not Applicable
• Study type: Observational

Clinical Trial Summary

This is a national, multi-center, observational, prospective photographic atlas study in subjects who are treated with infliximab for moderate-to-severe psoriasis in daily clinic according to local country regulations and reimbursement.

Description:

Subjects will enter this study using a non-probability sampling method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female, age >=18 with moderate-to-severe psoriasis.

• Patient for whom the physician has decided to initiate psoriasis treatment with infliximab in accordance with the terms of the European labeling.

• Patient must demonstrate his/her willingness to participate in the observational study by signing a written consent.

Exclusion Criteria:

• Patient unable to understand and answer a self administered questionnaire.

• No specific non-inclusion criteria will be applied to eligible patients.

• Contradiction and/or Precaution listed in the Summary of Product Characteristics.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• Infliximab
According to local country regulations.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists	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.	Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)	No
Primary	Dynamic Photographic PGA Score as Assessed by Two Dermatologists	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).	Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)	No
Secondary	Static PGA Score as Assessed by the Investigator	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.	Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)	No
Secondary	Dynamic PGA Score as Assessed by the Investigator	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.	Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)	No
Secondary	Percent Body Surface Area (BSA) Involved With Psoriasis		Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5),Week 30 (Visit 6)	No
Secondary	Psoriasis Area and Severity Index (PASI) Score	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).	Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)	No
Secondary	Nail Psoriasis Severity Index (NAPSI) Score	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).	Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)	No
Secondary	Static PGA Score as Assessed by the Participant	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.	Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)	No
Secondary	Dynamic PGA Score as Assessed by the Participant	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.	Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)	No
Secondary	Dermatology Life Quality Index (DLQI) Score	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.	Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)	No
Secondary	Number of Participants With Satisfactory Health Status	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)"	Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)	No