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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00749398

Acronym

PHODYPSO

Enrollment

133

Registered

2008-09-09

Start date

2007-09-30

Completion date

2010-09-30

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Brief 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.

Detailed description

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

Interventions

BIOLOGICALInfliximab

According to local country regulations.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists	Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)	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.
Dynamic Photographic PGA Score as Assessed by Two Dermatologists	Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)	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).

Secondary

Measure	Time frame	Description
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)	—
Psoriasis Area and Severity Index (PASI) Score	Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)	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).
Nail Psoriasis Severity Index (NAPSI) Score	Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)	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).
Static PGA Score as Assessed by the Investigator	Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)	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.
Dynamic PGA Score as Assessed by the Participant	Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)	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.
Dermatology Life Quality Index (DLQI) Score	Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)	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.
Number of Participants With Satisfactory Health Status	Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)	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)
Static PGA Score as Assessed by the Participant	Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)	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.
Dynamic PGA Score as Assessed by the Investigator	Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)	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.

Participant flow

Participants by arm

Arm	Count
Infliximab 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.	124
Total	124

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	4
Overall Study	Lack of Efficacy	7
Overall Study	Lost to Follow-up	11
Overall Study	Reason not specified	2
Overall Study	Serious adverse event	11
Overall Study	Unknown reason	1
Overall Study	Withdrawal by Subject	17

Baseline characteristics

Characteristic	Infliximab
Age, Continuous	46.9 years STANDARD_DEVIATION 13.7
Sex: Female, Male Female	45 Participants
Sex: Female, Male Male	79 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 133
serious Total, serious adverse events	17 / 133

Outcome results

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).

Time frame: Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)