Trial Outcomes & Findings for Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy (NCT NCT00948610)

NCT ID: NCT00948610

Last Updated: 2017-12-02

Results Overview

Slow wave sleep in minutes at post-infusion day 2 in placebo vs. remicade

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Post-infusion day 2
• Results posted on: 2017-12-02

Participant Flow

Participant milestones

Measure	Placebo Placebo-participant will receive placebo saline solution via IV route. Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route.	Remicade Remicade-Participant will be given 10 mg/kg of drug via IV route. Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route.
Overall Study STARTED	10	10
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy

Baseline characteristics by cohort

Measure	Placebo n=10 Participants Placebo-participant will receive placebo saline solution via IV route. Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route.	Remicade n=10 Participants Remicade-Participant will be given 10 mg/kg of drug via IV route. Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route.	Total n=20 Participants Total of all reporting groups
Age, Continuous	48.8 Years STANDARD_DEVIATION 14.0 • n=5 Participants	54.1 Years STANDARD_DEVIATION 13.3 • n=7 Participants	51.5 Years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Post-infusion day 2

Slow wave sleep in minutes at post-infusion day 2 in placebo vs. remicade

Outcome measures

Measure	Placebo n=10 Participants Placebo-participant will receive placebo saline solution via IV route. Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route.	Remicade n=10 Participants Remicade-Participant will be given 10 mg/kg of drug via IV route. Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route.
Slow Wave Sleep	82.6 Minutes Standard Deviation 39.5	67.3 Minutes Standard Deviation 38.7

SECONDARY outcome

Timeframe: Post-infusion day 2

Percentage of monocytes producing interleukin-6 at post-infusion day 2 in placebo vs. remicade

Outcome measures

Measure	Placebo n=10 Participants Placebo-participant will receive placebo saline solution via IV route. Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route.	Remicade n=10 Participants Remicade-Participant will be given 10 mg/kg of drug via IV route. Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route.
Cellular Inflammation	3.6 percentage of monocytes Standard Deviation 0.6	4.0 percentage of monocytes Standard Deviation 0.6

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Michael R. Irwin

UCLA

Phone: 3108258281

Email: mirwin1@ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place