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Study to Evaluate the Efficacy of Infliximab Induction Therapy for Patients With Palmoplantar Psoriasis (PPP)(Study P04555) (TIPS)
This study is currently recruiting participants.
Verified by Schering-Plough, January 2009
Sponsors and Collaborators: Schering-Plough
Centocor, Inc.
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00686686
  Purpose

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 whose deterioration of Psoriasis Severity Index (PASI) score is >50% from week 8 until week 12 compared to baseline score will be eligible for an additional infusion at Week 12 and will be followed up at Week 18.


Condition Intervention Phase
Psoriasis
Biological: Infliximab
Phase IV

MedlinePlus related topics: Psoriasis
Drug Information available for: Infliximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: A Multi Center, Open Label, Single-Arm Study to Evaluate the Efficacy of Infliximab Induction Therapy for Patients With Palmoplantar Psoriasis (PPP), Including the Pustular Form (PsPPP)

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Percentage of subjects who achieve more than 75% of improvement in Palmoplantar Psoriasis Activity Severity Index (PPPASI) after 3 infusions. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects who achieve a moderate response. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Percentage of subjects who maintain the initial clearance at Weeks 12 and 18. [ Time Frame: Weeks 12 and 18 ] [ Designated as safety issue: No ]
  • Percentage of subjects who respond to the fourth infusion. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Dermatology Life Quality Index [ Time Frame: Weeks 18 ] [ Designated as safety issue: No ]
  • Unexpected SAEs [ Time Frame: Weeks 18 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: December 2007
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Infliximab 5 mg/kg: Experimental
Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and optional at week 12.
Biological: Infliximab
Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and optional at week 12.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • Psoriasis of P&S with evidence of mild to moderate psoriasis elsewhere or 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 UV light sources during the study.
  • Eligible according to country-specific 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 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, 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 HIV, hepatitis B or C.
  • History of any clinically significant 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686686

Contacts
Contact: SP Clinical Trial Registry Call Center 1-888-772-8734

Locations
Israel
Investigational Site 15 Recruiting
Petach Tikva, Israel
Investigational Site 2 Recruiting
Ramat Gan, Israel
Investigational Site 3 Recruiting
Jerusalem, Israel
Investigational Site 4 Recruiting
Afula, Israel
Investigational Site 1 Recruiting
Petach Tikva, Israel
Sponsors and Collaborators
Schering-Plough
Centocor, Inc.
  More Information

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P04555
Study First Received: May 27, 2008
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00686686  
Health Authority: Israel: Ministry of Health;   Israel: Ethics Commission

Study placed in the following topic categories:
Skin Diseases
Infliximab
Psoriasis
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Therapeutic Uses
Gastrointestinal Agents
Antirheumatic Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009