Trial Outcomes & Findings for Centocor Microarray Study of Patients (NCT NCT00462072)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

31 participants

Primary outcome timeframe

Baseline (Wk 0)

Results posted on

2015-04-29

Participant Flow

A total of 31 subjects were enrolled from our clinic between April 4th, 2007 and June 8th, 2009.

Subjects were enrolled based on protocol inclusion / exclusion criteria. Subjects were required to be starting Infliximab as a requirement for entry into the study.

Participant milestones

Participant milestones
Measure	Psoriasis (Ps) Ps subjects taking Infliximab as part of their standard of care.	Psoriatic Arthritis (PsA) PsA subjects taking Infliximab as part of their standard of care.	Rheumatoid Arthritis (RA) RA subjects taking Infliximab as part of their standard of care.
Baseline (Week 0) STARTED	10	12	9
Baseline (Week 0) COMPLETED	10	12	9
Baseline (Week 0) NOT COMPLETED	0	0	0
Week 10 STARTED	10	12	9
Week 10 COMPLETED	10	12	9
Week 10 NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Centocor Microarray Study of Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rheumatoid Arthritis (RA) n=9 Participants RA subject starting Infliximab	Psoriatic Arthritis (PsA) n=12 Participants PsA subjects starting Infliximab	Psoriasis (Ps) n=10 Participants Ps subjects starting Infliximab	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	27 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Age, Continuous	52 years STANDARD_DEVIATION 11 • n=5 Participants	53 years STANDARD_DEVIATION 13 • n=7 Participants	41 years STANDARD_DEVIATION 15 • n=5 Participants	48 years STANDARD_DEVIATION 14 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Wk 0)

Population: Participant data analyzed per protocol using the following DAS28 formula \[(=0.56\*SQRT(Tender Joint Count)+0.28\*SQRT(Swollen Joint Count)+0.36\*LN(CRP(mg/L)+1)+0.014\*(Visual Analogue Scale+0.96 \]

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.

Outcome measures

Outcome measures
Measure	Psoriatic Arthritis (PsA) n=12 Participants PsA subjects starting Infliximab as part of their standard of care.	Rheumatoid Arthritis (RA) n=9 Participants RA subjects starting Infliximab as part of their standard of care.
Baseline (Wk 0) Disease Activity Score (DAS28)	4.54 Score Standard Deviation 1.24	6.03 Score Standard Deviation 1.16

PRIMARY outcome

Timeframe: Week 10

Population: Participant data analyzed per protocol using the following DAS28 formula \[(=0.56\*SQRT(Tender Joint Count)+0.28\*SQRT(Swollen Joint Count)+0.36\*LN(CRP(mg/L)+1)+0.014\*(Visual Analogue Scale+0.96 \]

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.

Outcome measures

Outcome measures
Measure	Psoriatic Arthritis (PsA) n=12 Participants PsA subjects starting Infliximab as part of their standard of care.	Rheumatoid Arthritis (RA) n=9 Participants RA subjects starting Infliximab as part of their standard of care.
Week 10 Disease Activity Score (DAS28)	3.34 Score Standard Deviation 1.06	4.13 Score Standard Deviation 1.28

PRIMARY outcome

Timeframe: Week 10

Population: Participant data analyzed per protocol using the following DAS28 formula \[(=0.56\*SQRT(Tender Joint Count)+0.28\*SQRT(Swollen Joint Count)+0.36\*LN(CRP(mg/L)+1)+0.014\*(Visual Analogue Scale+0.96 \]

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.

Outcome measures

Outcome measures
Measure	Psoriatic Arthritis (PsA) n=12 Participants PsA subjects starting Infliximab as part of their standard of care.	Rheumatoid Arthritis (RA) n=9 Participants RA subjects starting Infliximab as part of their standard of care.
Disease Activity Score (DAS28) Delta	1.21 Score Delta Standard Deviation 0.60	1.90 Score Delta Standard Deviation 1.48

PRIMARY outcome

Timeframe: Baseline (Wk 0)

Population: 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

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.

Outcome measures

Outcome measures
Measure	Psoriatic Arthritis (PsA) n=10 Participants PsA subjects starting Infliximab as part of their standard of care.	Rheumatoid Arthritis (RA) RA subjects starting Infliximab as part of their standard of care.
Baseline (Wk 0) Psoriasis Area and Severity Index (PASI)	5.26 Index Standard Deviation 1.82	—

PRIMARY outcome

Timeframe: Week 10

Population: 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

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.

Outcome measures

Outcome measures
Measure	Psoriatic Arthritis (PsA) n=10 Participants PsA subjects starting Infliximab as part of their standard of care.	Rheumatoid Arthritis (RA) RA subjects starting Infliximab as part of their standard of care.
Baseline (Wk 10) Psoriasis Area and Severity Index (PASI)	2.31 Index Standard Deviation 5.85	—

PRIMARY outcome

Timeframe: Week 10

Population: 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

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.

Outcome measures

Outcome measures
Measure	Psoriatic Arthritis (PsA) n=10 Participants PsA subjects starting Infliximab as part of their standard of care.	Rheumatoid Arthritis (RA) RA subjects starting Infliximab as part of their standard of care.
Psoriasis Area and Severity Index (PASI) Delta	2.95 Index Delta Standard Deviation 5.42	—

Adverse Events

Psoriasis (Ps)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Psoriatic Arthritis (PsA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rheumatoid Arthritis (RA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rick Barrett

University of Rochester

Phone: 585-275-1647

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place