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A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis

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ClinicalTrials.gov Identifier: NCT00353119
Recruitment Status : Completed
First Posted : July 17, 2006
Results First Posted : December 21, 2010
Last Update Posted : September 9, 2011
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Innovaderm Research Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Palmoplantaris Pustulosis
Interventions Drug: Placebo comparator
Drug: Etanercept
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Then Etanercept Etanercept
Hide Arm/Group Description Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1 then crossed over to etanercept 50mg twice weekly for weeks 12 to 24 Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
Period Title: First Intervention Day 0 to Week 12
Started 5 10
Completed 5 10
Not Completed 0 0
Period Title: Second Intervention Week 12 to Week 28
Started 5 10
Completed 5 10
Not Completed 0 0
Arm/Group Title Placebo Then Etanercept Etanercept Total
Hide Arm/Group Description Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1 then crossed over to etanercept 50mg twice weekly for weeks 12 to 24 Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 5 10 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 10 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
10
 100.0%
15
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 10 participants 15 participants
54.2  (4.76) 46.9  (13.3) 49.33  (11.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 10 participants 15 participants
Female
5
 100.0%
9
  90.0%
14
  93.3%
Male
0
   0.0%
1
  10.0%
1
   6.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 5 participants 10 participants 15 participants
5 10 15
PPPASI - Palmoplantar Pustulosis Area and Severity Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 5 participants 10 participants 15 participants
21.3  (10.3) 16.3  (5.0) 18.0  (7.3)
[1]
Measure Description:

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 m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible).

1.Primary Outcome
Title Percentage Change in Palmoplantar Pustulosis Severity Index (PPPASI) Before Crossover
Hide Description

Comparison of the percentage change in Palmoplantar pustulosis severity index PPPASI) at 12 weeks in patients treated with placebo or etanercept

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

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1
Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
Overall Number of Participants Analyzed 5 10
Mean (Standard Deviation)
Unit of Measure: Percentage change
30.1  (25.7) 7.1  (60.4)
2.Secondary Outcome
Title Number of Adverse Events
Hide Description Study the safety of etanercept in patients with PPP by collecting adverse events from the screening visit until week 28. For a given AE, a subject will be counted once even if he or she has experienced multiple episodes for that particular AE. An adverse event is any untoward medical occurrence including any clinically significant abnormal laboratory values or variation from the baseline condition to the last visit (week 28) in a patient receiving a pharmaceutical product, without regards to the possibility of a causal relationship with this treatment.
Time Frame 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that crossed over from placebo to etanercept are included in the Etanercept group. The placebo group only included adverse events from the first 12 weeks prior to the crossover. The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1
Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks AND Patients that crossed over to etanercept 50 mg subcutanously twice weekly after taking placebo for the first 12 weeks.
Overall Number of Participants Analyzed 5 15
Measure Type: Number
Unit of Measure: Adverse Events
13 57
3.Secondary Outcome
Title Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI)
Hide Description

Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months

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

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Percentage change
30.1  (36.1)
4.Secondary Outcome
Title Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) After Crossover
Hide Description

Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months

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

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.
Arm/Group Title Etanercept After Placebo
Hide Arm/Group Description:
Group 1 patients that crossed over to etanercept 50mg twice weekly for weeks 12 to 24 after having initiated the study with placebo for the first 12 weeks
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Percentage change
52.1  (15.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description Patients randomized to initiate the study with placebo for the first 12 weeks Patients randomized to etanercept who received etanercept 50 mg subcutaneously twice weekly for 24 weeks AND patients who crossed over to etanercept 50 mg subcutaneously twice a week for 12 weeks.
All-Cause Mortality
Placebo Etanercept
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Etanercept
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Etanercept
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      15/15 (100.00%)    
Blood and lymphatic system disorders     
Mild leucocytosis *  0/5 (0.00%)  0 1/15 (6.67%)  1
Ear and labyrinth disorders     
Positional vertigo *  0/5 (0.00%)  0 1/15 (6.67%)  1
Gastrointestinal disorders     
Abdominal Pain *  1/5 (20.00%)  1 0/15 (0.00%)  0
Diahhrea *  1/5 (20.00%)  1 1/15 (6.67%)  1
Nausea *  1/5 (20.00%)  1 2/15 (13.33%)  2
Wisdom tooth pain *  0/5 (0.00%)  0 1/15 (6.67%)  1
General disorders     
General Malaise *  0/5 (0.00%)  0 1/15 (6.67%)  1
Pain thoracic wall *  0/5 (0.00%)  0 1/15 (6.67%)  1
Infections and infestations     
Bronchitis *  1/5 (20.00%)  1 1/15 (6.67%)  1
Candida Vaginitis *  0/5 (0.00%)  0 1/15 (6.67%)  1
Cellulitis *  0/5 (0.00%)  0 1/15 (6.67%)  1
Common Cold *  2/5 (40.00%)  2 4/15 (26.67%)  6
Flu *  0/5 (0.00%)  0 1/15 (6.67%)  1
Herpes Labialis *  1/5 (20.00%)  1 1/15 (6.67%)  2
Pharyngitis *  0/5 (0.00%)  0 2/15 (13.33%)  2
Sinusitis *  0/5 (0.00%)  0 1/15 (6.67%)  1
Urinary Tract Infection *  1/5 (20.00%)  2 0/15 (0.00%)  0
Injury, poisoning and procedural complications     
Epicondylitis *  0/5 (0.00%)  0 1/15 (6.67%)  1
Investigations     
Occult hematuria *  0/5 (0.00%)  0 1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders     
Back Pain *  1/5 (20.00%)  1 1/15 (6.67%)  1
Increase in arthritis *  0/5 (0.00%)  0 1/15 (6.67%)  1
Increase in psoriatic arthritis *  0/5 (0.00%)  0 1/15 (6.67%)  1
Tendinitis *  1/5 (20.00%)  1 2/15 (13.33%)  2
Nervous system disorders     
Bilateral burning both feet *  0/5 (0.00%)  0 1/15 (6.67%)  1
Headache *  0/5 (0.00%)  0 4/15 (26.67%)  4
Psychiatric disorders     
Increase in depression *  0/5 (0.00%)  0 1/15 (6.67%)  1
Reproductive system and breast disorders     
Occasional spotting *  0/5 (0.00%)  0 1/15 (6.67%)  1
Skin and subcutaneous tissue disorders     
Erythema to thighs *  0/5 (0.00%)  0 1/15 (6.67%)  1
Injection site reaction *  1/5 (20.00%)  1 10/15 (66.67%)  14
Intermitant uticaria crisis *  0/5 (0.00%)  0 1/15 (6.67%)  1
Pruritus under both feet *  0/5 (0.00%)  0 1/15 (6.67%)  1
Worsening of feet plantar pustulosis *  0/5 (0.00%)  0 1/15 (6.67%)  1
Surgical and medical procedures     
Dental Extraction *  1/5 (20.00%)  1 0/15 (0.00%)  0
Vascular disorders     
Hematoma *  0/5 (0.00%)  0 1/15 (6.67%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Annie Levesque
Organization: Innovaderm Research Inc
Phone: 514-521-4285 ext 222
EMail: alevesque@innovaderm.ca
Layout table for additonal information
Responsible Party: Innovaderm Research Inc.
ClinicalTrials.gov Identifier: NCT00353119     History of Changes
Other Study ID Numbers: 2.3
First Submitted: July 14, 2006
First Posted: July 17, 2006
Results First Submitted: November 23, 2010
Results First Posted: December 21, 2010
Last Update Posted: September 9, 2011