A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612) (ESAQUALITY)
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: May 27, 2008
Last updated: October 19, 2015
Last verified: October 2015
Subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic therapy will be eligible to enroll in this study. Subjects will receive infliximab infusions (5 mg/kg of body weight) at Weeks 0, 2, 6, and 14 followed by a 12-week follow-up period. The efficacy of infliximab will be evaluated by the Psoriasis Area and Severity Index (PASI).
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Multi-center, Open Label Trial Evaluating the Efficacy , SAfety and the Impact on QUAlity of Life of Infliximab TherapY in Patients With Moderate-to-severe Psoriasis Not Responding to Standard or Biologic Therapy
Primary Outcome Measures:
- Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
PASI 75 response is defined as participants who achieved at least a
75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2009 (Final data collection date for primary outcome measure)
Experimental: Infliximab 5 mg/kg
Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6, and 14.
Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
Other Name: Remicade, SCH 215596
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- >=18 to 75 years of age, of either gender, and of any race.
- Psoriasis covering at least 10% of total body surface area (BSA) and PASI >=12 at Screening and Baseline.
- Diagnosis of moderate-to-severe psoriasis at least 6 months prior the screening.
- Eligible to infliximab who have failed at least 1 of the following: corticosteroids, methotrexate (MTX), systemic retinoids, cyclosporine, psoralen-ultraviolet A (PUVA), ultraviolet B (UVB) phototherapy, and/or biologics (etanercept or efalizumab).
- Eligible according to tuberculosis (TB) eligibility assessment, screening and early detection of reactivation rules.
- Chest x-ray within 3 months prior to Screening with no evidence of malignancy, infection, or fibrosis.
- Screening and Baseline tests (complete blood count [CBC], blood chemistry, and urinalysis) must be within protocol-specified parameters.
- Free of significant disease that could interfere with study evaluations.
- Willing to give written informed consent and able to adhere to protocol visits and procedures.
- Women of childbearing potential and all men must be using adequate birth control and must continue to do so for 6 months after receiving the last dose of study medication.
- Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.
- Standard concomitant psoriasis therapies.
- Active or latent TB.
- History of chronic infectious disease, opportunistic infection, or serious infection within 2 months of enrollment.
- History of lymphoproliferative disease.
- Malignancy in past 5 years (except treated basal cell carcinoma [BCC]).
- Treatment with tumor necrosis factor (TNF) antagonists within previous 6 weeks.
- Current drug-induced psoriasis.
- Females who are pregnant or nursing and females and males who are planning pregnancy within 6 months from the last infusion of infliximab.
- Previously treated with infliximab.
- Concomitant diagnosis of congestive heart failure (CHF) including medically-controlled asymptomatic subjects.
- History of chronic or recurrent infectious disease.
- Have or have had a serious infection or have been hospitalized or received intravenous antibiotics for an infection during the 2 months prior to Screening.
- Have or have had an opportunistic infection within 6 months prior to Screening.
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||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 27, 2008
|Results First Received:
||December 2, 2010
||October 19, 2015
||Italy: Ministry of Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 11, 2016
Skin Diseases, Papulosquamous
Anti-Inflammatory Agents, Non-Steroidal
Central Nervous System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents