Back to resultsA Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612) (ESAQUALITY)
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Infliximab
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- >=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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Infliximab 5 mg/kg
Arm Description
Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6, and 14.
Outcomes
Primary Outcome Measures
Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT00687401
First Posted
May 27, 2008
Last Updated
March 13, 2017
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Centocor, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00687401
Brief Title
A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612)
Acronym
ESAQUALITY
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Centocor, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
215 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Infliximab 5 mg/kg
Arm Type
Experimental
Arm Description
Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6, and 14.
Intervention Type
Biological
Intervention Name(s)
Infliximab
Other Intervention Name(s)
Remicade, SCH 215596
Intervention Description
Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
Primary Outcome Measure Information:
Title
Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score
Description
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).
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>=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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612)
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