Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 29 of 810 for:    Psoriasis 4

A Study to Evaluate the Switch From Etanercept to Infliximab in Subjects With Moderate-to-Severe Psoriasis (Study P05133) (TANGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00686595
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : February 24, 2011
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Biological: Infliximab
Enrollment 48
Recruitment Details  
Pre-assignment Details 48 participants were enrolled in this study. Of these, 38 participants received at least one dose of the study medication and represent the intent-to-treat (ITT) population.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Period Title: Overall Study
Started 38
Completed 31
Not Completed 7
Reason Not Completed
Adverse Event             3
Protocol Violation             1
Lost to Follow-up             1
Lack of Efficacy             1
Poor Compliance             1
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants
46.54  (9.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
10
  26.3%
Male
28
  73.7%
1.Primary Outcome
Title Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 10 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 10.
Time Frame Baseline and 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the intent-to-treat (ITT) population for whom the PASI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Percentage of participants
71
2.Secondary Outcome
Title PASI 75 Response Rate at Week 18
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 18 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 18.
Time Frame Baseline and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the PASI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: Percent of participants
94
3.Secondary Outcome
Title PASI 75 Response Rate at Week 24
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 24 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 24.
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the PASI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Percentage of participants
74
4.Secondary Outcome
Title PASI 50 Response Rate at Week 10
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 10 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 10.
Time Frame Baseline and 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the PASI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Percentage of participants
91
5.Secondary Outcome
Title PASI 50 Response Rate at Week 18
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 18 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 18.
Time Frame Baseline and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the PASI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: Percentage of participants
97
6.Secondary Outcome
Title PASI 50 Response Rate at Week 24
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 24 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 24.
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the PASI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Percentage of participants
89
7.Secondary Outcome
Title PASI 90 Response Rate at Week 10
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 10 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 10.
Time Frame Baseline and 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the PASI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Percentage of participants
37
8.Secondary Outcome
Title PASI 90 Response Rate at Week 18
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 18 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 18.
Time Frame Baseline and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the PASI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: Percentage of participants
56
9.Secondary Outcome
Title PASI 90 Response Rate at Week 24
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 24 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 24.in PASI at Week 24
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the PASI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Percentage of participants
54
10.Secondary Outcome
Title PASI 100 Response Rate at Week 10
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 10 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 10.
Time Frame Baseline and 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the PASI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Percentage of participants
17
11.Secondary Outcome
Title PASI 100 Response Rate at Week 18
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 18 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 18.
Time Frame Baseline and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the PASI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: Percentage of participants
31
12.Secondary Outcome
Title PASI 100 Response Rate at Week 24
Hide Description PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 24 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 24.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the PASI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Percentage of participants
40
13.Secondary Outcome
Title Percent Reduction in Self-Administered Psoriasis Area Severity Index (SAPASI) at Week 18
Time Frame Baseline and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the SAPASI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: Percent reduction
89  (15)
14.Secondary Outcome
Title Percent Reduction in SAPASI at Week 24
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the SAPASI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: Percent reduction
82  (29)
15.Secondary Outcome
Title Percent Reduction in Affected Body Surface Area (BSA) at Week 18
Hide Description The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the participant’s body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district. The percent reduction in affected BSA at Week 18 compared to baseline is reported.
Time Frame Baseline and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the BSA assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: Percent reduction
82  (28)
16.Secondary Outcome
Title Percent Reduction in Affected BSA at Week 24
Hide Description The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the participant’s body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district. The percent reduction in affected BSA at Week 24 compared to baseline is reported.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the BSA assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: Percent reduction
72  (39)
17.Secondary Outcome
Title Percent Reduction in Visual Analogue Scale (VAS) Referred Itch at Week 18
Hide Description VAS was used to measure itch. Participants reported itch using VAS - a line ranging from 0 cm to 10 cm, measured by the investigator. 0 cm referred to absence of itch and 10 cm referred to severe itching. The percent reduction in VAS at Week 18 compared to baseline is reported.
Time Frame Baseline and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the VAS assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: Percent reduction
81  (27)
18.Secondary Outcome
Title Percent Reduction in VAS Referred Itch at Week 24
Hide Description VAS was used to measure itch. Participants reported itch using VAS - a line ranging from 0 cm to 10 cm, measured by the investigator. 0 cm referred to absence of itch and 10 cm referred to severe itching. The percent reduction in VAS at Week 24 compared to baseline is reported.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the VAS assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: Percent reduction
72  (38)
19.Secondary Outcome
Title Percent Reduction in Dermatology Life Quality Index (DLQI) Total Score at Week 18
Hide Description DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The percent reduction in DLQI score at Week 18 compared to baseline is reported.
Time Frame Baseline and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the DLQI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: Percent reduction
77  (35)
20.Secondary Outcome
Title Percent Reduction in DLQI Total Score at Week 24
Hide Description DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The percent reduction in DLQI score at Week 24 compared to baseline is reported.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the DLQI assessment was available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: Percent reduction
68  (50)
21.Secondary Outcome
Title Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18
Hide Description The SKINDEX-29 measures the quality of life in dermatological participants, who complete a questionnaire assessing 3 scales - burden of symptoms, social functioning and emotional state. Participants answered 29 questions referring to the previous 4-week period, on a 5-point scale from “never” (=0) to “all the time” (=4). The score for each scale ranges from 0 to 100 and higher scores reflect a worse quality of life. The percent reduction in SKINDEX-29 scores at Week 18 compared to baseline is reported.
Time Frame Baseline and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the SKINDEX-29 assessments were available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: Percent reduction
Symptoms score 42  (26)
Emotional state score 39  (25)
Social functioning score 39  (27)
22.Secondary Outcome
Title Percent Reduction in SKINDEX-29 Scores at Week 24
Hide Description The SKINDEX-29 measures the quality of life in dermatological participants, who complete a questionnaire assessing 3 scales - burden of symptoms, social functioning and emotional state. Participants answered 29 questions referring to the previous 4-week period, on a 5-point scale from “never” (=0) to “all the time” (=4). The score for each scale ranges from 0 to 100 and higher scores reflect a worse quality of life. The percent reduction in SKINDEX-29 scores at Week 24 compared to baseline is reported.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population for whom the SKINDEX-29 assessments were available.
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description:
Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: Percent reduction
Symptoms score 40  (29)
Emotional state score 32  (34)
Social functioning score 31  (36)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infliximab 5 mg/kg
Hide Arm/Group Description Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
All-Cause Mortality
Infliximab 5 mg/kg
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Infliximab 5 mg/kg
Affected / at Risk (%) # Events
Total   7/38 (18.42%)    
Cardiac disorders   
Mitral Valve Prolapse  1/38 (2.63%)  1
General disorders   
Cyst  1/38 (2.63%)  1
Electrocution  1/38 (2.63%)  1
Injury, poisoning and procedural complications   
Overdose  3/38 (7.89%)  4
Psychiatric disorders   
Completed Suicide  1/38 (2.63%)  1
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infliximab 5 mg/kg
Affected / at Risk (%) # Events
Total   12/38 (31.58%)    
Gastrointestinal disorders   
Gastritis  2/38 (5.26%)  2
Infections and infestations   
Bronchitis  2/38 (5.26%)  2
Rhinitis  3/38 (7.89%)  3
Investigations   
Blood Triglycerides Increased  2/38 (5.26%)  2
Transaminases Increased  2/38 (5.26%)  2
Nervous system disorders   
Dizziness  2/38 (5.26%)  2
Skin and subcutaneous tissue disorders   
Pruritus  4/38 (10.53%)  11
1
Term from vocabulary, MedDRA 12.1
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.

Investigator agrees not to publish or publicly present any of the

study results without prior written authorization from sponsor, except than for the dispositions provided in the Minister’s Decree and Ministerial Circular. Investigator agrees to provide 45 days written notice to sponsor prior to submission for publication or presentation to permit sponsor to review copies of abstracts/manuscripts for publication (including text for oral presentations) which report any study results.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharpe & Dohme Corp
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00686595     History of Changes
Other Study ID Numbers: P05133
First Submitted: May 27, 2008
First Posted: May 30, 2008
Results First Submitted: January 27, 2011
Results First Posted: February 24, 2011
Last Update Posted: April 12, 2017