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Safety and Efficacy of Infliximab in Palmoplantar Psoriasis

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Innovaderm Research Inc.
ClinicalTrials.gov Identifier:
NCT00629772
First received: February 27, 2008
Last updated: September 1, 2011
Last verified: September 2011
History of Changes
Results First Received: April 14, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Palmoplantar Psoriasis
Interventions: Drug: Placebo
Drug: Infliximab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Then Infliximab Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
Infliximab Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.

Participant Flow for 2 periods

 Period 1:   First Intervention - Day 0 - Week 14
    Placebo Then Infliximab     Infliximab  
STARTED     12     12  
COMPLETED     12     12  
NOT COMPLETED     0     0  

Period 2:   Second Intervention Week 14 - Week 26
    Placebo Then Infliximab     Infliximab  
STARTED     12 [1]   12  
COMPLETED     11     10  
NOT COMPLETED     1     2  
Adverse Event                 1                 1  
Lack of Efficacy                 0                 1  
[1] Patient withdrew at Week 14 and therefore never received infliximab.



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Then Infliximab Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
Infliximab Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
Total Total of all reporting groups

Baseline Measures
    Placebo Then Infliximab     Infliximab     Total  
Number of Participants  
[units: participants]
 		  12     12     24  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     11     9     20  
>=65 years     1     3     4  
Age  
[units: years]
Mean ± Standard Deviation 		  49.92  ± 14.74     57.83  ± 12.42     53.87  ± 13.92  
Gender  
[units: participants]
 		     
Female     8     7     15  
Male     4     5     9  
Region of Enrollment  
[units: participants]
 		     
Canada     12     12     24  
Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) [1]
[units: Units on a scale]
Mean ± Standard Deviation 		  26.7  ± 12.4     24.1  ± 11.4     25.4  ± 11.7  
Dermatology Life Quality Index (DLQI) [2]
[units: Units on a scale]
Mean ± Standard Deviation 		  11.9  ± 6.9     9.8  ± 4.4     10.8  ± 5.8  
Physician's Global Assessment (PGA) [3]
[units: Units on as scale]
Mean ± Standard Deviation 		  3.8  ± 0.6     3.5  ± 0.7     3.7  ± 0.6  
Palmoplantar Psoriasis Surface Area PPSA [4]
[units: Percentage of affected area]
Mean ± Standard Deviation 		  40.4  ± 21.6     37.1  ± 21.0     38.8  ± 20.9  
[1]

m-PPPASI = (E + I + D) Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).

Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible).
[2]

Impact on quality of life with the Dermatology Life Quality Index (DLQI) The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.

  • 0-1 = no effect at all on patient's life
  • 2-5 = small effect on patient's life
  • 6-10 = moderate effect on patient's life
  • 11-20 = very large effect on patient's life
  • 21-30 = extremely large effect on patient's life
[3]

Efficacy by comparing the mean Physician's Global Assessment(PGA).

  • 0 = clear
  • 1 = almost clear
  • 2 = Mild
  • 3 = Moderate
  • 4 = Severe
  • 5 = Very severe
[4] Efficacy by comparing the mean percent PPSA. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles. A sole completely covered with psoriasis would have a PPSA of 30% (if the other sole and the palms are unaffected) while a palm completely covered with psoriasis would have a PPSA of 20% (if the other palm and the soles are unaffected).



  Outcome Measures
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1.  Primary:   75% Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) From Day 0   [ Time Frame: 14 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Number of Adverse Events at Week 14   [ Time Frame: 14 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Mean Dermatology Life Quality Index (DLQI) at Week 14   [ Time Frame: 14 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Mean Percent Palmoplantar Psoriasis Surface Area (PPSA) at Week 14   [ Time Frame: 14 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Mean Physician's Global Assessment (PGA) at Week 14   [ Time Frame: 14 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Mean Percent Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) at Week 26   [ Time Frame: Baseline, 26 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Mean Percent Improvement in Dermatology Life Quality Index (DLQI) at Week 26   [ Time Frame: Baseline, 26 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Mean Percent Improvement in Physician's Global Assessment (PGA) at Week 26   [ Time Frame: Baseline, 26 weeks ]
  Hide Outcome Measure 8

Measure Type Secondary
Measure Title Mean Percent Improvement in Physician's Global Assessment (PGA) at Week 26
Measure Description

Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in Physician's Global Assessment (PGA) from Day 0 to Week 26.

  • 0 = clear
  • 1 = almost clear
  • 2 = Mild
  • 3 = Moderate
  • 4 = Severe
  • 5 = Very severe
Time Frame Baseline, 26 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).

Reporting Groups
  Description
Infliximab Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.

Measured Values
    Infliximab  
Number of Participants Analyzed  
[units: participants]
 		  12  
Mean Percent Improvement in Physician's Global Assessment (PGA) at Week 26  
[units: Percent improvement]
Mean ± Standard Deviation 		  47.92  ± 41.76  

No statistical analysis provided for Mean Percent Improvement in Physician's Global Assessment (PGA) at Week 26



9.  Secondary:   Mean Percent Improvement in Palmoplantar Psoriasis Surface Area (PPSA) at Week 26   [ Time Frame: Baseline, 26 weeks ]
  Show Outcome Measure 9


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The lack of validated scales to specifically assess severity of palmoplantar psoriasis. The study was powered to detect a difference of 55 percentage points.  


Results Point of Contact:  
Name/Title: Annie Levesque
Organization: Innovaderm Research
phone: 514 521 4285 ext 222
e-mail: alevesque@innovaderm.ca


No publications provided


Responsible Party: Innovaderm Research Inc.
ClinicalTrials.gov Identifier: NCT00629772     History of Changes
Other Study ID Numbers: Inno-6003, P-05121
Study First Received: February 27, 2008
Results First Received: April 14, 2010
Last Updated: September 1, 2011
Health Authority: Canada: Health Canada