A Study to Evaluate Remicade (Infliximab) in Moderate-to-Severe Chronic Plaque Psoriasis in the Middle Eastern Population (Study P04528)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00687362
First received: May 27, 2008
Last updated: February 17, 2010
Last verified: February 2010
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Purpose
Middle Eastern subjects with moderate-to-severe chronic plaque psoriasis will be administered infusions of infliximab (Remicade) at 5 mg/kg of body weight at Weeks 0, 2, 6, 14, and 22. The safety and efficacy of infliximab monotherapy will be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Biological: Infliximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Multinational, Open Label Study on the Efficacy and Safety of Infliximab Monotherapy in Moderate-to-severe Chronic Plaque Psoriasis in Middle Eastern Population |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 22 |
| Study Start Date: | May 2006 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Infliximab 5 mg/kg
Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
|
Biological: Infliximab
Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Other Name: Remicade, SCH 215596
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years or older, either gender, and any race.
- Psoriasis affecting >=5% of body surface, PASI score >=10 (maximum score 72).
- History of plaque psoriasis for >6 months.
- Informed written consent.
- Refractory to other anti-psoriasis agents (topical corticosteroids, phototherapy UVa [PUVA], or systemic therapy).
- Negative chest x-ray and purified protein derivative (PPD) within 1 month.
- Understand and be able to adhere to dosing and visit schedules.
- Screening laboratory tests must meet protocol-specified criteria.
- Women and men of childbearing potential must be using adequate birth control measures and should continue such precautions for 6 months after last infusion of infliximab.
Exclusion Criteria:
- Pregnant, nursing, or planned pregnancy within 6 months after last scheduled treatment.
- Used topical corticosteroids in previous 14 days or systemic therapy (phototherapy UVb [UVB], PUVA, cyclosporine, methotrexate) in previous 28 days, or received treatment with anti-tumor necrosis factor (TNF)-alpha monoclonal antibodies, human or murine immunoglobulins, TNF-alpha receptor fusion proteins, or other bioengineered fusion proteins.
- Received previous immunobiologics.
- Have HIV, hepatitis B or C.
- Recently transplanted (exception - corneal transplant >3 months prior to first infusion) or known malignancy or history of malignancy within previous 5 years (exception - basal or squamous cell carcinoma of skin that has been treated with no evidence of recurrence).
- Concurrent medications that are not permitted.
- congestive heart failure (CHF)
- Use of cyclosporine or tacrolimus within 4 weeks prior to Screening.
- Use of intramuscular (IM), intravenous (IV), or oral corticosteroids within 4 weeks prior to Screening.
- Treatment with any investigational drug within 3 months prior to Screening.
- Allergy to murine proteins.
- Serious infections (hepatitis, pneumonia, pyelonephritis) in previous 3 months.
- History of active tuberculosis (TB) requiring treatment within previous 3 years, or history of opportunistic infections (herpes zoster) within 2 months of Screening.
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological or cerebral disease.
- Current signs or symptoms of other severe uncontrolled disease which in investigator's opinion would put the subject at an unacceptable risk.
- History of current alcohol or drug abuse.
- Not observed designated washout periods for any of the prohibited medications in protocol.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00687362 History of Changes |
| Other Study ID Numbers: | P04528 |
| Study First Received: | May 27, 2008 |
| Results First Received: | February 17, 2010 |
| Last Updated: | February 17, 2010 |
| Health Authority: | United Arab Emirates: General Authority for Health Services for Abu Dhabi |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Infliximab Dermatologic Agents |
Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 16, 2013