Trial Outcomes & Findings for Photographic Library of Moderate to Severe Psoriasis Subjects Treated With Infliximab (Study P05047) (NCT NCT00749398)
NCT ID: NCT00749398
Last Updated: 2015-07-28
Results Overview
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.
COMPLETED
133 participants
Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
2015-07-28
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
124
|
|
Overall Study
COMPLETED
|
71
|
|
Overall Study
NOT COMPLETED
|
53
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
7
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Serious adverse event
|
11
|
|
Overall Study
Withdrawal by Subject
|
17
|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Reason not specified
|
2
|
|
Overall Study
Unknown reason
|
1
|
Baseline Characteristics
Photographic Library of Moderate to Severe Psoriasis Subjects Treated With Infliximab (Study P05047)
Baseline characteristics by cohort
| Measure |
Infliximab
n=124 Participants
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.
|
|---|---|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)Population: Per protocol analysis.
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.
Outcome measures
| Measure |
Infliximab
n=124 Participants
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.
|
|---|---|
|
Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists
Visit 1 (n=117)
|
3.15 Score on a scale
Standard Deviation 1.02
|
|
Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists
Visit 2 (n=102)
|
2.77 Score on a scale
Standard Deviation 0.98
|
|
Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists
Visit 3 (n=96)
|
2.08 Score on a scale
Standard Deviation 1.01
|
|
Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists
Visit 4 (n=86)
|
1.76 Score on a scale
Standard Deviation 0.95
|
|
Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists
Visit 5 (n=69)
|
1.49 Score on a scale
Standard Deviation 0.86
|
|
Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists
Visit 6 (n=67)
|
1.72 Score on a scale
Standard Deviation 1.04
|
PRIMARY outcome
Timeframe: Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)Population: Per protocol analysis.
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).
Outcome measures
| Measure |
Infliximab
n=124 Participants
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.
|
|---|---|
|
Dynamic Photographic PGA Score as Assessed by Two Dermatologists
Change between Visit 1 and Visit 4 (n=80)
|
7.05 Score on a scale
Standard Deviation 2.32
|
|
Dynamic Photographic PGA Score as Assessed by Two Dermatologists
Change between Visit 1 and Visit 6 (n=54)
|
7.7 Score on a scale
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)Population: Per protocol analysis.
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.
Outcome measures
| Measure |
Infliximab
n=124 Participants
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.
|
|---|---|
|
Static PGA Score as Assessed by the Investigator
Visit 4 (n=91)
|
1.92 Score on a scale
Standard Deviation 1.17
|
|
Static PGA Score as Assessed by the Investigator
Visit 5 (n=81)
|
1.72 Score on a scale
Standard Deviation 1.21
|
|
Static PGA Score as Assessed by the Investigator
Visit 1 (n=124)
|
3.84 Score on a scale
Standard Deviation 0.80
|
|
Static PGA Score as Assessed by the Investigator
Visit 2 (n=111)
|
3.21 Score on a scale
Standard Deviation 0.90
|
|
Static PGA Score as Assessed by the Investigator
Visit 3 (n=101)
|
2.27 Score on a scale
Standard Deviation 1.11
|
|
Static PGA Score as Assessed by the Investigator
Visit 6 (n=74)
|
2.03 Score on a scale
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)Population: Per protocol analysis.
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.
Outcome measures
| Measure |
Infliximab
n=124 Participants
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.
|
|---|---|
|
Dynamic PGA Score as Assessed by the Investigator
Change between Visit 1 and Visit 4 (n=88)
|
7.27 Score on a scale
Standard Deviation 2.63
|
|
Dynamic PGA Score as Assessed by the Investigator
Change between Visit 1 and Visit 6 (n=70)
|
7.28 Score on a scale
Standard Deviation 3.04
|
SECONDARY outcome
Timeframe: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5),Week 30 (Visit 6)Population: Per protocol analysis.
Outcome measures
| Measure |
Infliximab
n=124 Participants
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.
|
|---|---|
|
Percent Body Surface Area (BSA) Involved With Psoriasis
Visit 1 (n=123)
|
42.33 Percent BSA Involved with Psoriasis
Standard Deviation 27.12
|
|
Percent Body Surface Area (BSA) Involved With Psoriasis
Visit 2 (n=111)
|
34.86 Percent BSA Involved with Psoriasis
Standard Deviation 25.95
|
|
Percent Body Surface Area (BSA) Involved With Psoriasis
Visit 3 (n=99)
|
22.95 Percent BSA Involved with Psoriasis
Standard Deviation 23.84
|
|
Percent Body Surface Area (BSA) Involved With Psoriasis
Visit 4 (n=91)
|
16.86 Percent BSA Involved with Psoriasis
Standard Deviation 21.42
|
|
Percent Body Surface Area (BSA) Involved With Psoriasis
Visit 5 (n=80)
|
10.84 Percent BSA Involved with Psoriasis
Standard Deviation 14.17
|
|
Percent Body Surface Area (BSA) Involved With Psoriasis
Visit 6 (n=74)
|
14.12 Percent BSA Involved with Psoriasis
Standard Deviation 19.26
|
SECONDARY outcome
Timeframe: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)Population: Per protocol analysis.
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).
Outcome measures
| Measure |
Infliximab
n=124 Participants
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.
|
|---|---|
|
Psoriasis Area and Severity Index (PASI) Score
Visit 6 (n=74)
|
7.17 Score on a scale
Standard Deviation 8.92
|
|
Psoriasis Area and Severity Index (PASI) Score
Visit 1 (n=124)
|
21.92 Score on a scale
Standard Deviation 15.02
|
|
Psoriasis Area and Severity Index (PASI) Score
Visit 2 (n=109)
|
12.95 Score on a scale
Standard Deviation 10.23
|
|
Psoriasis Area and Severity Index (PASI) Score
Visit 3 (n=101)
|
8.00 Score on a scale
Standard Deviation 8.83
|
|
Psoriasis Area and Severity Index (PASI) Score
Visit 4 (n=90)
|
6.38 Score on a scale
Standard Deviation 7.60
|
|
Psoriasis Area and Severity Index (PASI) Score
Visit 5 (n=81)
|
5.33 Score on a scale
Standard Deviation 6.41
|
SECONDARY outcome
Timeframe: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)Population: Per protocol analysis.
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).
Outcome measures
| Measure |
Infliximab
n=124 Participants
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.
|
|---|---|
|
Nail Psoriasis Severity Index (NAPSI) Score
Visit 1 (n=86)
|
28.74 Score on a scale
Standard Deviation 23.19
|
|
Nail Psoriasis Severity Index (NAPSI) Score
Visit 2 (n=75)
|
27.08 Score on a scale
Standard Deviation 23.35
|
|
Nail Psoriasis Severity Index (NAPSI) Score
Visit 3 (n=70)
|
22.17 Score on a scale
Standard Deviation 21.95
|
|
Nail Psoriasis Severity Index (NAPSI) Score
Visit 4 (n=64)
|
18.64 Score on a scale
Standard Deviation 19.95
|
|
Nail Psoriasis Severity Index (NAPSI) Score
Visit 5 (n=53)
|
17.53 Score on a scale
Standard Deviation 20.83
|
|
Nail Psoriasis Severity Index (NAPSI) Score
Visit 6 (n=52)
|
15.67 Score on a scale
Standard Deviation 17.59
|
SECONDARY outcome
Timeframe: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)Population: Per protocol analysis.
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.
Outcome measures
| Measure |
Infliximab
n=124 Participants
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.
|
|---|---|
|
Static PGA Score as Assessed by the Participant
Visit 1 (n=121)
|
4.02 Score on a scale
Standard Deviation 0.9
|
|
Static PGA Score as Assessed by the Participant
Visit 2 (n=101)
|
3.35 Score on a scale
Standard Deviation 0.98
|
|
Static PGA Score as Assessed by the Participant
Visit 3 (n=96)
|
2.5 Score on a scale
Standard Deviation 1.25
|
|
Static PGA Score as Assessed by the Participant
Visit 4 (n=87)
|
2.24 Score on a scale
Standard Deviation 1.27
|
|
Static PGA Score as Assessed by the Participant
Visit 5 (n=77)
|
1.9 Score on a scale
Standard Deviation 1.27
|
|
Static PGA Score as Assessed by the Participant
Visit 6 (n=71)
|
2.2 Score on a scale
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)Population: Per protocol analysis.
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.
Outcome measures
| Measure |
Infliximab
n=124 Participants
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.
|
|---|---|
|
Dynamic PGA Score as Assessed by the Participant
Change between Visit 1 and Visit 4 (n=80)
|
6.91 Score on a scale
Standard Deviation 2.57
|
|
Dynamic PGA Score as Assessed by the Participant
Change between Visit 1 and Visit 6 (n=70)
|
6.56 Score on a scale
Standard Deviation 3.32
|
SECONDARY outcome
Timeframe: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)Population: Per protocol analysis.
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.
Outcome measures
| Measure |
Infliximab
n=124 Participants
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.
|
|---|---|
|
Dermatology Life Quality Index (DLQI) Score
Visit 1 (n=114)
|
13.55 Score on a scale
Standard Deviation 7.27
|
|
Dermatology Life Quality Index (DLQI) Score
Visit 2 (n=99)
|
8.75 Score on a scale
Standard Deviation 6.4
|
|
Dermatology Life Quality Index (DLQI) Score
Visit 3 (n=91)
|
5.46 Score on a scale
Standard Deviation 5.55
|
|
Dermatology Life Quality Index (DLQI) Score
Visit 4 (n=79)
|
4.89 Score on a scale
Standard Deviation 6.07
|
|
Dermatology Life Quality Index (DLQI) Score
Visit 5 (n=76)
|
4.18 Score on a scale
Standard Deviation 6.11
|
|
Dermatology Life Quality Index (DLQI) Score
Visit 6 (n=69)
|
5.39 Score on a scale
Standard Deviation 6.81
|
SECONDARY outcome
Timeframe: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)Population: Per protocol analysis.
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)"
Outcome measures
| Measure |
Infliximab
n=124 Participants
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.
|
|---|---|
|
Number of Participants With Satisfactory Health Status
Visit 1 (n=118)
|
9 Participants
|
|
Number of Participants With Satisfactory Health Status
Visit 2 (n=98)
|
42 Participants
|
|
Number of Participants With Satisfactory Health Status
Visit 3 (n=94)
|
61 Participants
|
|
Number of Participants With Satisfactory Health Status
Visit 4 (n=83)
|
61 Participants
|
|
Number of Participants With Satisfactory Health Status
Visit 5 (n=77)
|
63 Participants
|
|
Number of Participants With Satisfactory Health Status
Visit 6 (n=68)
|
46 Participants
|
Adverse Events
Infliximab
Serious adverse events
| Measure |
Infliximab
n=133 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Gastrointestinal disorders
Oral pruritus
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Gastrointestinal disorders
Palatal oedema
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
General disorders
General physical health deterioration
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
General disorders
Pyrexia
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Immune system disorders
Anaphylactic reaction
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Infections and infestations
Bronchitis
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Infections and infestations
Tuberculosis
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Investigations
Tuberculosis test positive
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Investigations
Weight decreased
|
0.75%
1/133 • Number of events 2
All 133 participants enrolled in the study were included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
2/133 • Number of events 2
All 133 participants enrolled in the study were included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Nervous system disorders
Paraesthesia
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Nervous system disorders
Syncope vasovagal
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Renal and urinary disorders
Polyuria
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.5%
2/133 • Number of events 2
All 133 participants enrolled in the study were included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.75%
1/133 • Number of events 1
All 133 participants enrolled in the study were included in the safety population.
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER