Safety and Efficacy of Infliximab in Palmoplantar Psoriasis

NCT00629772 | Completed Phase 3 Results

• 2 other identifiers: Inno-6003P-05121
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Palmoplantar Psoriasis

Keywords

Palmoplantar psoriasis; Infliximab

Outcome Measures

Primary Outcomes (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).

  14 weeks

Secondary Outcomes (8)

• Number of Adverse Events at Week 14

  14 weeks

• Mean Dermatology Life Quality Index (DLQI) at Week 14

  14 weeks

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

  14 weeks

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

  14 weeks

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

  Baseline, 26 weeks

Study Arms (2)

Placebo then infliximab

PLACEBO COMPARATOR

Placebo at weeks 0, 2, 6 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.

Drug: Placebo; Drug: Infliximab

Infliximab

ACTIVE COMPARATOR

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

Drug: Infliximab

Interventions

Placebo DRUG

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

Also known as: Saline

Placebo then infliximab

Infliximab DRUG

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.

Also known as: Remicade

Infliximab; Placebo then infliximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Innovaderm Research Inc.: lead
• Schering-Plough: collaborator

Study Sites (5)

The Guenther Dermatology Research Center

London, Ontario, N6A 3H7, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1A8, Canada

Location

Innovaderm Research Laval

Laval, Quebec, H7S 2C6, Canada

Location

Innovaderm Research

Montreal, Quebec, H2K 4L5, Canada

Location

Centre de recherche dermatologique du Québec Métropolitain

Québec, Quebec, G1V 4X7, Canada

Location

MeSH Terms

Interventions

Sodium Chloride; Infliximab

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

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

• Title: Annie Levesque
• Organization: Innovaderm Research

alevesque@innovaderm.ca

514 521 4285

Study Officials

• Robert Bissonnette, MD

  Innovaderm Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 6, 2008
• Study Start: March 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 9, 2011
• Results First Posted: September 2, 2010

Record last verified: 2011-09

Locations

CA (5)