Trial Outcomes & Findings for Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment (Study P04465)(COMPLETED) (NCT NCT00778869)

Results Overview

Differentially expressed genes were described as those which were at least 1.5 times up- or down-regulated and statistically different at a significance level of 0.05 using a paired t-test comparing 10 ankylosing spondylitis (AS) participants during tumor necrosis factor (TNF) alpha treatment (Remicade) with 10 matched controls. Control samples were previously obtained and not specifically collected for this study.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

14 weeks

Results posted on

2015-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	Remicade Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment (Study P04465)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remicade n=10 Participants Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 weeks

Differentially expressed genes were described as those which were at least 1.5 times up- or down-regulated and statistically different at a significance level of 0.05 using a paired t-test comparing 10 ankylosing spondylitis (AS) participants during tumor necrosis factor (TNF) alpha treatment (Remicade) with 10 matched controls. Control samples were previously obtained and not specifically collected for this study.

Outcome measures

Outcome measures
Measure	Remicade n=10 Participants Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54 in participants with AS.
Number of Genes Which Were Differentially Expressed Number of Genes	54675 Number of genes
Number of Genes Which Were Differentially Expressed Number of Genes Up/Down Regulated	890 Number of genes
Number of Genes Which Were Differentially Expressed Number of Genes Highly Expressed	701 Number of genes

Adverse Events

Remicade

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

Senior Vice President, Global Clinical Development

Merck, Sharp & Dohme Corp

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Principal investigator (PI) agrees not to publish or publicly present any interim results of study without prior written consent of sponsor. PI further agrees to provide 30 days written notice to sponsor prior to submission for publication or presentation to permit sponsor to review copies of abstracts or manuscripts for publication including without limitation slides and texts of oral or other public presentations and text of any transmission through any electronic media which report results.
Publication restrictions are in place

Restriction type: OTHER