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Palmoplantar PsoriasisPhase 3NCT00629772

Safety and Efficacy of Infliximab in Palmoplantar Psoriasis

A Phase 3 study testing Infliximab in people with Palmoplantar Psoriasis, run by Innovaderm Research Inc. at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Palmoplantar psoriasis is a variant of psoriasis affecting palms and soles. It is one of the most debilitating variants of psoriasis which very often interferes with daily activities and with the ability to work. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Palmoplantar Psoriasis
What is being tested?
Infliximab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
5 sitesCanada
Study dates
Mar 2007to Jul 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is 18 years of age or older.
  • Patient has a history of palmoplantar psoriasis for at least 6 months.
  • Patient has a m-PPPASI of at least 8 with at least 10% of the total surface of palms and soles affected with psoriasis at baseline
  • Patients who failed either 4 weeks (or more) of treatment with a potent or superpotent topical corticosteroid, methotrexate, acitretin, cyclosporine, efalizumab, etanercept or alefacept for the treatment of palmoplantar psoriasis. Patients with a positive PPD who accept TB prophylaxis, will need to have failed 4 weeks (or more) of treatment with methotrexate, acitretin, cyclosporine, efalizumab, etanercept, alefacept or any other systemic therapies for the treatment of palmoplantar psoriasis.
  • Patient with a history and/or the presence of typical plaque psoriasis outside palms and soles
  • Female patient is either not of childbearing potential or is of childbearing potential and practicing an acceptable contraception
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  • Female patients of childbearing potential must have a negative serum pregnancy test at the Screening visit.
  • Patient is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, and physical examination performed at Screening
  • The investigator evaluates that the benefit / risk ratio is acceptable for the patient.
  • Patients must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
  • Negative PPD
  • Patients with a positive PPD may be eligible if they initiate TB prophylaxis before the first injection of infliximab

Who cannot join

  • Patient has a history of pustules on palms and/or soles or currently has evidence of pustules on palms and/or soles.
  • Patient with Chest X Ray findings positive or suspicious for active tuberculosis.
  • Patient has had opportunistic infections.
  • Patient has had active TB or recent close contact with an individual with active TB.
  • Patient has had a serious infection, has been hospitalized for an infection, or has been treated with intravenous (IV) antibiotics for an infection within 2 months prior to Day 0.
  • Patient has had a chronic or recurrent infectious disease including hepatitis B or hepatitis C.
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  • Patient has a known malignancy or history of malignancy within 5-year period prior to screening (with the exception of squamous or basal cell carcinoma of the skin that has been completely excised without evidence of recurrence).
  • Patient has a history of lymphoproliferative disease, has multiple sclerosis, or other central demyelinating disorder, or congestive heart failure.
  • Patient has elevated aspartate aminotransferase or alanine aminotransferase levels more than twice the upper limit of normal at screening.
  • Patient has received live vaccination within 3 months of randomization or plans to receive live vaccination during the study or within 3 months after the last infusion.
  • Patient is pregnant, breastfeeding, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.
  • Patient has a history of an allergic reaction to infliximab or any constituent of study drug.
  • Patient who has used any topical treatment for psoriasis (except non-medicated emollients) in the last 2 weeks before Day 0 with the exception of hydrocortisone and desonide for the face, groin (including genitals) and inframammary areas as well as shampoos containing tar, salicylic acid or zinc pyrithione
  • Patient who has used UVB phototherapy or excessive sun exposure less than 14 days before Day 0.
  • Patient has used any non-biological systemic therapy for the treatment of psoriasis (including PUVA therapy), systemic steroids or systemic immunosuppressants less than 28 days before Day 0. Investigational non-biologics agents must be discontinued at least 28 days or 5 half-lives prior to Day 0 (whichever is longer).
  • Patient is currently participating in a clinical trial with an experimental drug or device.
  • Patient who has used any biological therapy for the treatment of psoriasis less than 90 days before day 0.
  • Patient is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed. Patients who have used oral or injectable corticosteroids less than 28 days before Day 0 are excluded.
  • Patient has a poorly controlled medical condition which, in the opinion of the investigator, would put the patient at risk if the patient participated in the study.
  • Patient currently uses or plans to use anti-retroviral therapy at any time during the study.
  • Patient is known to have immune deficiency or is immunocompromised.
  • Patient is known to be infected with the human immunodeficiency virus, hepatitis B or hepatitis C virus.
  • Patient has current signs or symptoms or has a history of systemic lupus erythematosus.
  • Patient has a history of clinically significant drug or alcohol abuse in the last year.
  • Patient has erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis.
  • Patients with a positive PPD who accept TB prophylaxis must not have any pre-existing liver disease.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Innovaderm Research Laval

    Laval, Quebec, H7S 2C6

  • The Guenther Dermatology Research Center

    London, Ontario, N6A 3H7

  • Lynderm Research Inc.

    Markham, Ontario, L3P 1A8

  • Innovaderm Research

    Montreal, Quebec, H2K 4L5

  • Centre de recherche dermatologique du Québec Métropolitain

    Québec, Quebec, G1V 4X7

Other trials in Canada

About this study

Official title: A Double-Blind Study on the Safety and Efficacy of Infliximab in Palmoplantar Psoriasis

Palmoplantar psoriasis is a variant of psoriasis affecting palms and soles. It is one of the most debilitating variants of psoriasis which very often interferes with daily activities and with the ability to work. This type of psoriasis is very difficult to treat as topicals have difficulty penetrating the thick epidermis of palms and soles and are therefore not very effective. The response to standard agents (methotrexate, cyclosporine and acitretin) is also usually limited. A number of these patients have very severe hand and feet disease with mild to no involvement elsewhere on the body.

Given the efficacy of infliximab in psoriasis, the purpose of this study is to evaluate if infliximab is safe and if it will improve severity and quality of life in patients with palmoplantar psoriasis, a debilitating variant of psoriasis.

Read the detailed description

A total of 24 patients with non-pustular palmoplantar psoriasis affecting at least 10% of the combined palms and soles area and with a modified palmoplantar pustulosis area severity index (m-PPPASI) of at least 8 will be recruited. Patients will be randomized (1:1) to receive either infliximab 5 mg/kg or placebo (normal saline) on weeks 0, 2 and 6. Patients assigned to placebo during the first 3 infusions will receive infliximab 5 mg/kg at weeks 14, 16 and 20 and placebo again at week 22 while patients who were assigned to receive infliximab during the first 3 infusions will receive infliximab at week 14 and placebo at week 16 and week 20 as well as infliximab for the last infusion at week 22. The primary endpoint will be at week 14. Patients will come back to the clinic at week 26 for a final efficacy and safety assessment.

Efficacy will be evaluated by assessing psoriasis plaque severity on palms and soles (physician's global assessment PGA), percentage of palms and soles area affected by psoriasis (palmoplantar surface area - PPSA) as well as m-PPPASI (modified palmoplantar pustulosis area and severity index). Quality of life will be evaluated at every visit by performing the dermatology life quality index DLQI. Safety will be evaluated by repeating chemistry and haematology laboratories at regular visits as well as by physical examinations and assessment of adverse events.

Being tested
Placebo, Infliximab
Keywords
Palmoplantar psoriasis, Infliximab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Also called Saline

    Patients receive placebo on weeks 0, 2 and 6. They receive infliximab 5mg/kg at weeks 14, 16 and 20.

  • InfliximabDrug

    Also called Remicade

    Patients in infliximab group receive infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22. Patients in placebo then infliximab group receive placebo at weeks 0, 2, 6, then receive infliximab at weeks 14, 16 and 20.

Study groups in NCT00629772
Study groupRoleWhat they receive
Placebo then infliximabPlacebo comparatorPlacebo at weeks 0, 2, 6 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
Receives: Drug: Placebo; Drug: Infliximab
InfliximabActive comparatorInfliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
Receives: Drug: Infliximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 75% Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) From Day 0

    Efficacy by comparing the number of patients reaching a 75% improvement in m-PPPASI (m-PPPASI 75) 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 m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible).

    Measured: 14 weeks

Secondary outcomes (8)

  1. Number of Adverse Events at Week 14

    Safety of infliximab administered for 14 weeks in patients who received by comparing adverse events

    Measured: 14 weeks

  2. Mean Dermatology Life Quality Index (DLQI) at Week 14

    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

    Measured: 14 weeks

  3. Mean Percent Palmoplantar Psoriasis Surface Area (PPSA) at Week 14

    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).

    Measured: 14 weeks

  4. Mean Physician's Global Assessment (PGA) at Week 14

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

    • 0 = clear.
    • 1 = almost clear.
    • 2 = Mild.
    • 3 = Moderate.
    • 4 = Severe.
    • 5 = Very severe.

    Measured: 14 weeks

  5. Mean Percent Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) at Week 26

    Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in modified m-PPPASI from Day 0 to Week 26.

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

    Measured: Baseline, 26 weeks

  6. Mean Percent Improvement in Dermatology Life Quality Index (DLQI) at Week 26

    Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in dermatology life quality index (DLQI) from Day 0 to Week 26.

    Impact on quality of life with the 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

    Measured: Baseline, 26 weeks

  7. Mean Percent Improvement in Physician's Global Assessment (PGA) at Week 26

    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

    Measured: Baseline, 26 weeks

  8. Mean Percent Improvement in Palmoplantar Psoriasis Surface Area (PPSA) at Week 26

    Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in percent PPSA from Day 0 to Week 26. 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.

    Measured: Baseline, 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2008 (estimated)
  2. Study startMar 2007
  3. Primary completionFeb 2009
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00629772
Sponsor's protocol ID
Inno-6003
Other IDs
P-05121
Status last verified
Sep 2011
First submitted
27 Feb 2008
Last updated
9 Sep 2011
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Infliximab in people with Palmoplantar Psoriasis, run by Innovaderm Research Inc. at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

75% Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) From Day 0 (time frame: 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00629772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2011.

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