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Centocor Microarray Study of Patients

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ClinicalTrials.gov Identifier: NCT00462072
Recruitment Status : Completed
First Posted : April 18, 2007
Results First Posted : January 16, 2012
Last Update Posted : April 29, 2015
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Christopher Ritchlin, University of Rochester

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Rheumatoid Arthritis
Psoriatic Arthritis
Psoriasis
Crohn's Disease
Intervention Drug: Infliximab
Enrollment 31
Recruitment Details A total of 31 subjects were enrolled from our clinic between April 4th, 2007 and June 8th, 2009.
Pre-assignment Details Subjects were enrolled based on protocol inclusion / exclusion criteria. Subjects were required to be starting Infliximab as a requirement for entry into the study.
Arm/Group Title Psoriasis (Ps) Psoriatic Arthritis (PsA) Rheumatoid Arthritis (RA)
Hide Arm/Group Description Ps subjects taking Infliximab as part of their standard of care. PsA subjects taking Infliximab as part of their standard of care. RA subjects taking Infliximab as part of their standard of care.
Period Title: Baseline (Week 0)
Started 10 12 9
Completed 10 12 9
Not Completed 0 0 0
Period Title: Week 10
Started 10 12 9
Completed 10 12 9
Not Completed 0 0 0
Arm/Group Title Rheumatoid Arthritis (RA) Psoriatic Arthritis (PsA) Psoriasis (Ps) Total
Hide Arm/Group Description RA subject starting Infliximab PsA subjects starting Infliximab Ps subjects starting Infliximab Total of all reporting groups
Overall Number of Baseline Participants 9 12 10 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 12 participants 10 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  88.9%
9
  75.0%
10
 100.0%
27
  87.1%
>=65 years
1
  11.1%
3
  25.0%
0
   0.0%
4
  12.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 12 participants 10 participants 31 participants
52  (11) 53  (13) 41  (15) 48  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 12 participants 10 participants 31 participants
Female
8
  88.9%
6
  50.0%
6
  60.0%
20
  64.5%
Male
1
  11.1%
6
  50.0%
4
  40.0%
11
  35.5%
1.Primary Outcome
Title Baseline (Wk 0) Disease Activity Score (DAS28)
Hide Description The DAS28 for RA and PsA subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The baseline DAS28 is an average of the study populations baseline disease activity score prior to the administration of Infliximab (remicade). A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A subject is considered to be in remission if they have a DAS28 lower than 2.6.
Time Frame Baseline (Wk 0)
Hide Outcome Measure Data
Hide Analysis Population Description
Participant data analyzed per protocol using the following DAS28 formula [(=0.56*SQRT(Tender Joint Count)+0.28*SQRT(Swollen Joint Count)+0.36*LN(CRP(mg/L)+1)+0.014*(Visual Analogue Scale+0.96 ]
Arm/Group Title Psoriatic Arthritis (PsA) Rheumatoid Arthritis (RA)
Hide Arm/Group Description:
PsA subjects starting Infliximab as part of their standard of care.
RA subjects starting Infliximab as part of their standard of care.
Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: Score
4.54  (1.24) 6.03  (1.16)
2.Primary Outcome
Title Week 10 Disease Activity Score (DAS28)
Hide Description The DAS28 for RA and PsA subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The week 10 DAS28 is an average of the study population's week 10 disease activity score after taking infliximab (remicade) for 10 weeks. A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A subject is considered to be in remission if they have a DAS28 lower than 2.6.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participant data analyzed per protocol using the following DAS28 formula [(=0.56*SQRT(Tender Joint Count)+0.28*SQRT(Swollen Joint Count)+0.36*LN(CRP(mg/L)+1)+0.014*(Visual Analogue Scale+0.96 ]
Arm/Group Title Psoriariatic Arthritis (PsA) Rheumatoid Arthritis (RA)
Hide Arm/Group Description:
PsA subjects taking Infliximab as part of their standard of care.
RA subjects taking Infliximab as part of their standard of care.
Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: Score
3.34  (1.06) 4.13  (1.28)
3.Primary Outcome
Title Disease Activity Score (DAS28) Delta
Hide Description The DAS28 Delta for RA and PsA subjects is measure used to determine the change in the severity of an individual's disease with positive delta indicating an improvement in the severity of subject's disease and a negative delta indicating a worsening of a subject's disease. The delta score is used to monitor treatment. The week 10 DAS28 Delta is determined by calculating the average change between the wk 0 and wk 10 DAS28.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participant data analyzed per protocol using the following DAS28 formula [(=0.56*SQRT(Tender Joint Count)+0.28*SQRT(Swollen Joint Count)+0.36*LN(CRP(mg/L)+1)+0.014*(Visual Analogue Scale+0.96 ]
Arm/Group Title Psoriatic Arthritis (PsA) Rheumatoid Arthritis
Hide Arm/Group Description:
PsA subjects taking Infliximab as part of their standard of care.
RA subjects taking Infliximab as part of their standard of care.
Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: Score Delta
1.21  (0.60) 1.90  (1.48)
4.Primary Outcome
Title Baseline (Wk 0) Psoriasis Area and Severity Index (PASI)
Hide Description A PASI score for Ps subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The baseline PASI is an average of the study populations baseline disease activity score prior to the administration of infliximab (remicade). While higher PASI scores indicate more severe psoriasis, it is difficult for subjects or doctors to describe the clinical severity for any specific PASI number.
Time Frame Baseline (Wk 0)
Hide Outcome Measure Data
Hide Analysis Population Description
PASI formula PASI = 0.1 * (erythemahead + indurationhead + desquamationhead) * Area Scorehead + 0.2 * (erythemaarm + indurationarm + desquamationarm) * Area Scorearm + 0.3 * (erythematorso + indurationtorso + desquamationtorso) * Area Scoretorso + 0.4 * (erythemaleg + indurationleg + desquamationleg) * Area Scoreleg
Arm/Group Title Psoriasis (Ps)
Hide Arm/Group Description:
Ps subjects taking Infliximab as part of their standard of care.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Index
5.26  (1.82)
5.Primary Outcome
Title Baseline (Wk 10) Psoriasis Area and Severity Index (PASI)
Hide Description A PASI score for Ps subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The week 10 PASI is an average of the study population's week 10 disease activity score after taking infliximab (remicade) for 10 weeks.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
PASI formula PASI = 0.1 * (erythemahead + indurationhead + desquamationhead) * Area Scorehead + 0.2 * (erythemaarm + indurationarm + desquamationarm) * Area Scorearm + 0.3 * (erythematorso + indurationtorso + desquamationtorso) * Area Scoretorso + 0.4 * (erythemaleg + indurationleg + desquamationleg) * Area Scoreleg
Arm/Group Title Psoriasis (Ps)
Hide Arm/Group Description:
Ps subjects taking Infliximab as part of their standard of care.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Index
2.31  (5.85)
6.Primary Outcome
Title Psoriasis Area and Severity Index (PASI) Delta
Hide Description The PASI Delta for Ps subjects is a measure used to determine the change in the severity of an individual's disease with a positive delta indicating an improvement in the severity of subject's disease and a negative delta indicating a worsening of a subject's disease. The delta score is used to monitor treatment. The week 10 PASI Delta is determined by calculating the average change between the wk 0 and wk 10 PASI.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
PASI formula PASI = 0.1 * (erythemahead + indurationhead + desquamationhead) * Area Scorehead + 0.2 * (erythemaarm + indurationarm + desquamationarm) * Area Scorearm + 0.3 * (erythematorso + indurationtorso + desquamationtorso) * Area Scoretorso + 0.4 * (erythemaleg + indurationleg + desquamationleg) * Area Scoreleg
Arm/Group Title Psoriasis (Ps)
Hide Arm/Group Description:
Ps subjects taking Infliximab as part of their standard of care.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Index Delta
2.95  (5.42)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Psoriasis (Ps) Psoriatic Arthritis (PsA) Rheumatoid Arthritis (RA)
Hide Arm/Group Description Ps subjects taking Infliximab as part of their standard of care. PsA subjects taking Infliximab as part of their standard of care. RA subjects taking Infliximab as part of their standard of care.
All-Cause Mortality
Psoriasis (Ps) Psoriatic Arthritis (PsA) Rheumatoid Arthritis (RA)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Psoriasis (Ps) Psoriatic Arthritis (PsA) Rheumatoid Arthritis (RA)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/12 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Psoriasis (Ps) Psoriatic Arthritis (PsA) Rheumatoid Arthritis (RA)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/12 (0.00%)   0/9 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Rick Barrett
Organization: University of Rochester
Phone: 585-275-1647
EMail: rick_barrett@urmc.rochester.edu
Layout table for additonal information
Responsible Party: Christopher Ritchlin, University of Rochester
ClinicalTrials.gov Identifier: NCT00462072    
Other Study ID Numbers: MA-01
First Submitted: April 17, 2007
First Posted: April 18, 2007
Results First Submitted: August 2, 2011
Results First Posted: January 16, 2012
Last Update Posted: April 29, 2015