Status:
COMPLETED
Safety and Efficacy of Infliximab in Palmoplantar Psoriasis
Lead Sponsor:
Innovaderm Research Inc.
Collaborating Sponsors:
Schering-Plough
Conditions:
Palmoplantar Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 abil...
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) o...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00629772
Start Date
March 1 2007
End Date
July 1 2009
Last Update
September 9 2011
Active Locations (5)
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1
The Guenther Dermatology Research Center
London, Ontario, Canada, N6A 3H7
2
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1A8
3
Innovaderm Research Laval
Laval, Quebec, Canada, H7S 2C6
4
Innovaderm Research
Montreal, Quebec, Canada, H2K 4L5