Trial Outcomes & Findings for A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis (NCT NCT00353119)

Last Updated: 2011-09-09

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

15 participants

Primary outcome timeframe

12 weeks

Results posted on

2011-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Then Etanercept 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	Etanercept Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
First Intervention Day 0 to Week 12 STARTED	5	10
First Intervention Day 0 to Week 12 COMPLETED	5	10
First Intervention Day 0 to Week 12 NOT COMPLETED	0	0
Second Intervention Week 12 to Week 28 STARTED	5	10
Second Intervention Week 12 to Week 28 COMPLETED	5	10
Second Intervention Week 12 to Week 28 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Then Etanercept n=5 Participants 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	Etanercept n=10 Participants Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	54.2 years STANDARD_DEVIATION 4.76 • n=5 Participants	46.9 years STANDARD_DEVIATION 13.3 • n=7 Participants	49.33 years STANDARD_DEVIATION 11.56 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Canada	5 participants n=5 Participants	10 participants n=7 Participants	15 participants n=5 Participants
PPPASI - Palmoplantar Pustulosis Area and Severity Index	21.3 Units on a scale STANDARD_DEVIATION 10.3 • n=5 Participants	16.3 Units on a scale STANDARD_DEVIATION 5.0 • n=7 Participants	18.0 Units on a scale STANDARD_DEVIATION 7.3 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1	Etanercept n=10 Participants Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
Percentage Change in Palmoplantar Pustulosis Severity Index (PPPASI) Before Crossover	30.1 Percentage change Standard Deviation 25.7	7.1 Percentage change Standard Deviation 60.4

SECONDARY outcome

Timeframe: 28 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1	Etanercept n=15 Participants Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
Number of Adverse Events	13 Adverse Events	57 Adverse Events

SECONDARY outcome

Timeframe: 24 weeks

Population: The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.

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).

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1	Etanercept Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI)	30.1 Percentage change Standard Deviation 36.1	—

SECONDARY outcome

Timeframe: 12 weeks

Population: The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1	Etanercept Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) After Crossover	52.1 Percentage change Standard Deviation 15.4	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Etanercept

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=5 participants at risk Patients randomized to initiate the study with placebo for the first 12 weeks	Etanercept n=15 participants at risk；n=10 participants at risk 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.
Gastrointestinal disorders Abdominal Pain	20.0% 1/5 • Number of events 1	0.00% 0/15
Musculoskeletal and connective tissue disorders Back Pain	20.0% 1/5 • Number of events 1	6.7% 1/15 • Number of events 1
Nervous system disorders Bilateral burning both feet	0.00% 0/5	6.7% 1/15 • Number of events 1
Infections and infestations Bronchitis	20.0% 1/5 • Number of events 1	6.7% 1/15 • Number of events 1
Infections and infestations Candida Vaginitis	0.00% 0/5	6.7% 1/15 • Number of events 1
Infections and infestations Cellulitis	0.00% 0/5	6.7% 1/15 • Number of events 1
Infections and infestations Common Cold	40.0% 2/5 • Number of events 2	26.7% 4/15 • Number of events 6
Surgical and medical procedures Dental Extraction	20.0% 1/5 • Number of events 1	0.00% 0/15
Gastrointestinal disorders Diahhrea	20.0% 1/5 • Number of events 1	6.7% 1/15 • Number of events 1
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/5	6.7% 1/15 • Number of events 1
Skin and subcutaneous tissue disorders Erythema to thighs	0.00% 0/5	6.7% 1/15 • Number of events 1
Infections and infestations Flu	0.00% 0/5	6.7% 1/15 • Number of events 1
General disorders General Malaise	0.00% 0/5	6.7% 1/15 • Number of events 1
Nervous system disorders Headache	0.00% 0/5	26.7% 4/15 • Number of events 4
Vascular disorders Hematoma	0.00% 0/5	6.7% 1/15 • Number of events 2
Infections and infestations Herpes Labialis	20.0% 1/5 • Number of events 1	6.7% 1/15 • Number of events 2
Musculoskeletal and connective tissue disorders Increase in arthritis	0.00% 0/5	6.7% 1/15 • Number of events 1
Psychiatric disorders Increase in depression	0.00% 0/5	6.7% 1/15 • Number of events 1
Musculoskeletal and connective tissue disorders Increase in psoriatic arthritis	0.00% 0/5	6.7% 1/15 • Number of events 1
Skin and subcutaneous tissue disorders Injection site reaction	20.0% 1/5 • Number of events 1	66.7% 10/15 • Number of events 14
Skin and subcutaneous tissue disorders Intermitant uticaria crisis	0.00% 0/5	6.7% 1/15 • Number of events 1
Blood and lymphatic system disorders Mild leucocytosis	0.00% 0/5	6.7% 1/15 • Number of events 1
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1	13.3% 2/15 • Number of events 2
Reproductive system and breast disorders Occasional spotting	0.00% 0/5	6.7% 1/15 • Number of events 1
Investigations Occult hematuria	0.00% 0/5	6.7% 1/15 • Number of events 1
General disorders Pain thoracic wall	0.00% 0/5	6.7% 1/15 • Number of events 1
Infections and infestations Pharyngitis	0.00% 0/5	13.3% 2/15 • Number of events 2
Ear and labyrinth disorders Positional vertigo	0.00% 0/5	6.7% 1/15 • Number of events 1
Skin and subcutaneous tissue disorders Pruritus under both feet	0.00% 0/5	6.7% 1/15 • Number of events 1
Infections and infestations Sinusitis	0.00% 0/5	6.7% 1/15 • Number of events 1
Musculoskeletal and connective tissue disorders Tendinitis	20.0% 1/5 • Number of events 1	13.3% 2/15 • Number of events 2
Infections and infestations Urinary Tract Infection	20.0% 1/5 • Number of events 2	0.00% 0/15
Gastrointestinal disorders Wisdom tooth pain	0.00% 0/5	6.7% 1/15 • Number of events 1
Skin and subcutaneous tissue disorders Worsening of feet plantar pustulosis	0.00% 0/5	6.7% 1/15 • Number of events 1

Additional Information

Annie Levesque

Innovaderm Research Inc

Phone: 514-521-4285

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60