Study to Evaluate the Efficacy of Infliximab Induction Therapy for Patients With Palmoplantar Psoriasis (PPP)(Study P04555)(COMPLETED)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Infliximab
Intervention description: Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Subjects with psoriasis will receive intravenous infliximab 5 mg/kg given over a 2-hour
      period at Weeks 0, 2, and 6 (induction therapy) to evaluate the efficacy of infliximab at
      Week 18. Subjects who achieved >=75% improvement in Psoriasis Pustulosa Palmoplantaris Area
      and Severity Index (PPPASI) score at Week 8 AND had deterioration of PPPASI score of 50% from
      Week 8 until Week 12 were to receive an additional infusion at Week 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-70 years of age at time of enrollment; male or female.

          -  Women of childbearing potential and all men must be using adequate birth control
             measures and should continue using such measures until 6 months after receiving the
             last infusion of study agent.

          -  Plaque-type psoriasis with evidence of mild to moderate psoriasis elsewhere or
             Psoriasis Pustulosa Palmo Plantaris (PPPP) of 6 months duration at least.

          -  Adhere to study visit schedule and other protocol requirements.

          -  Capable of giving informed consent prior to any study related procedures.

          -  Avoid prolonged sun exposure, including tanning booths or other ultraviolet (UV) light
             sources during the study.

          -  Eligible according to country-specific tuberculosis (TB) screening, eligibility
             assessment, and prevention rules.

          -  Chest x-ray within 3 months prior to first infusion with no evidence of malignancy,
             infection, or fibrosis.

          -  Screening laboratory test results within parameters specified in protocol.

        Exclusion Criteria:

          -  Have any other form of psoriasis besides palmoplantaris and the pustular form.

          -  Pregnant, nursing, or planning pregnancy within 6 months after last infusion.

          -  Previous treatment with infliximab or any therapeutic agent targeted at reducing
             tumor-necrosis factor (TNF), including but not limited to etanercept, thalidomide,
             CDP870, or D2E7.

          -  Other inflammatory disease that might confound the evaluations of benefit from the
             infliximab therapy, including but not limited to, rheumatoid arthritis (RA),
             ankylosing spondylitis, systemic lupus erythematosus, Lyme disease.

          -  Used any investigational drug within the previous 1 month or 5 times the half life of
             the investigational agent, whichever is longer, or 3 months for any biologic of
             unknown half life.

          -  Received any systemic medications/treatments that could affect psoriasis or PASI
             evaluation within 1 month prior to study.

          -  Used topical medications/treatments that could affect psoriasis or PASI evaluation
             within 2 or 4 weeks of baseline visit.

          -  Treated with any anti-CD4 antibody in the last 6 month.

          -  Received any systemic immunosuppressive within 4 weeks prior to first infusion.

          -  Received within 3 months prior to first infusion or are expected to receive any live
             virus or bacterial vaccinations during the trial or up to 3 months after the last
             infusion.

          -  History of chronic or recurrent infectious disease, including but not limited to
             chronic renal infection, chronic chest infection, recurrent urinary tract infection,
             or open, draining or infected skin wounds or ulcers.

          -  Serious infection or been hospitalized or received IV antibiotics for an infection
             during the previous 2 months.

          -  Have or had opportunistic infection.

          -  Herpes zoster infection within 2 months of baseline.

          -  Infected with human immunodeficiency virus (HIV), hepatitis B or C.

          -  History of any clinically significant adverse events (AEs) to murine or chimeric
             proteins or human/murine recombinant products.

          -  Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic,
             hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral,
             or psychiatric disease.

          -  History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic
             neuritis.

          -  Systemic lupus erythematosus.

          -  Transplanted organ.

          -  History of lymphoproliferative disease, including lymphoma, or signs and symptoms
             suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual
             size or location.

          -  Malignancy within previous 5 years.

          -  Concomitant diagnosis of congestive heart failure (CHF).

          -  Unable or unwilling to undergo multiple venipunctures because of poor tolerability or
             lack of easy access to veins.

          -  Substance abuse problem within previous 3 years.

          -  Hypersensitivity reaction/adverse reaction to paracetamol/acetaminophen,
             antihistamines, topical corticosteroids.

          -  Participation in another trial using an investigational agent or procedure during this
             trial.