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PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept

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ClinicalTrials.gov Identifier: NCT00527072
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : June 24, 2010
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Centocor Ortho Biotech Services, L.L.C.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Biological: infliximab
Enrollment 217
Recruitment Details A total of 217 subjects enrolled into the study but 2 subjects did not receive any study medication so they were excluded from analysis.
Pre-assignment Details  
Arm/Group Title Infliximab
Hide Arm/Group Description Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
Period Title: Overall Study
Started 215
Completed 179
Not Completed 36
Reason Not Completed
Adverse Event             13
Lack of Efficacy             11
Lost to Follow-up             3
Protocol Violation             2
Withdrawal by Subject             7
Arm/Group Title Infliximab
Hide Arm/Group Description Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
Overall Number of Baseline Participants 215
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 215 participants
<=18 years
1
   0.5%
Between 18 and 65 years
198
  92.1%
>=65 years
16
   7.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 215 participants
44.4  (13.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 215 participants
Female
78
  36.3%
Male
137
  63.7%
1.Primary Outcome
Title Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0)
Hide Description Patients who did not have a PGA score at Week 10 will be treated as not having achieved a PGA score of minimal (1) or clear (0) at Week 10. Specifically, treatment failures prior to Week 10 will be classified as not having a minimal (1) or clear (0).
Time Frame Week 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis is based on the evaluable population that includes the all enrolled patients who received at least one infliximab infusion, and had a baseline PGA score greater than 1.
Arm/Group Title Infliximab
Hide Arm/Group Description:
Open-label study, patients received IV infusions of 5 mg/kg infliximab at Weeks 0, 2, 6, 14, and 22
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: participants
138
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infliximab
Comments null hypothesis H0: proportion = 0.30
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method exact binomial distribution
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion
Estimated Value 0.654
Confidence Interval (2-Sided) 95%
0.586 to 0.718
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 10
Hide Description A PASI 50 responder is defined as a patient who has achieved at least a 50% improvement in the overall PASI score from baseline. PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A score less than 10 signifies a mixture of mild and moderate disease; a score greater than 10 but less than or equal to 30 signifies moderate disease; and a score greater than 30 signifies severe disease.
Time Frame Week 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on observed mITT (modified Intent to Treat) patients. Treatment failures are classified as not achieving a PASI 50, 75, 90, or 100 response at all visits after the date of treatment failure. For non-treatment failure patients who did not have a PASI score at the visit due to other reasons, will not have data imputed at that visit.
Arm/Group Title Infliximab
Hide Arm/Group Description:
Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: participants
167
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infliximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method exact binomial distribution
Comments [Not Specified]
Method of Estimation Estimation Parameter proportion
Estimated Value 0.791
Confidence Interval (2-Sided) 95%
0.730 to 0.844
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 26
Hide Description [Not Specified]
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis is based on all observed mITT patients. The treatment failures will be classified as not achieving a PASI 50, 75, 90, or 100 response at all visits after the date of treatment failure. For non-treatment failure patients who did not have a PASI score at the visit due to other reasons, their data at that visit will not be imputed.
Arm/Group Title Infliximab
Hide Arm/Group Description:
Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
Overall Number of Participants Analyzed 209
Measure Type: Number
Unit of Measure: participants
135
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infliximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method exact binomial distribution
Comments [Not Specified]
Method of Estimation Estimation Parameter proportion
Estimated Value 0.646
Confidence Interval (2-Sided) 95%
0.577 to 0.711
Estimation Comments [Not Specified]
Time Frame Adverse Events were collected from the time of patient informed consent until the Week 30 follow-up assement, for each patient.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infliximab
Hide Arm/Group Description Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
All-Cause Mortality
Infliximab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Infliximab
Affected / at Risk (%)
Total   8/215 (3.72%) 
Cardiac disorders   
Myocardial ischaemia * 1  1/215 (0.47%) 
Gastrointestinal disorders   
Gastritis * 1  1/215 (0.47%) 
Infections and infestations   
Bursitis infective * 1  1/215 (0.47%) 
Cellulitis * 1  1/215 (0.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Squamous cell carcinoma * 1  1/215 (0.47%) 
Squamous cell carcinoma of the cervix * 1  1/215 (0.47%) 
Nervous system disorders   
Convulsion * 1  1/215 (0.47%) 
Paraesthesia * 1  1/215 (0.47%) 
Skin and subcutaneous tissue disorders   
Pustular psoriasis * 1  1/215 (0.47%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infliximab
Affected / at Risk (%)
Total   63/215 (29.30%) 
Infections and infestations   
Upper respiratory tract infection * 1  21/215 (9.77%) 
Nasopharyngitis * 1  12/215 (5.58%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  19/215 (8.84%) 
Nervous system disorders   
Headache * 1  14/215 (6.51%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  11/215 (5.12%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Sr. Director, Clinical Research - Medical Affairs
Organization: Janssen Biotech, Inc.
Phone: 215-325-5711
Responsible Party: Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier: NCT00527072     History of Changes
Other Study ID Numbers: CR014500
C0168Z04 ( Other Identifier: Centocor Ortho Biotech Services, L.L.C. )
First Submitted: September 6, 2007
First Posted: September 10, 2007
Results First Submitted: May 28, 2010
Results First Posted: June 24, 2010
Last Update Posted: September 3, 2012