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NCT00948610 · ClinicalTrials.gov registry record · NA
Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy
A NA study of Rheumatoid Arthritis, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00948610: Completed NA study of Rheumatoid Arthritis, sponsored by University of California, Los Angeles.
NCT00948610 is a NA study of Rheumatoid Arthritis that has completed, run by University of California, Los Angeles. The registered enrollment target is 20 participants, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00948610, a NA study of Rheumatoid Arthritis, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
More than half of rheumatoid arthritis (RA) patients complain of sleep disturbance and this cardinal complaint is associated with fatigue, pain, and depressed mood in patient with chronic inflammatory disorder. Despite the frequency of this complaint, there is limited efforts to evaluate sleep or the abnormal increases in the expression of pro-inflammatory cytokines play a key role in the progression of RA, we hypothesize that the cytokine network is one physiological system that is associated with sleep disturbances in RA patients. Pro-inflammatory cytokines signal the central nervous system and are associated with increased symptoms of pain, fatigue, and depressed mood in rheumatic patients. The specific aims of the study are to examine the contribution of cytokines on sleep by administering a TNF antagonist vs. placebo to probe the action of pro-inflammatory cytokines on sleep in RA Patients. Examination of sleep and its consequences for pro-inflammatory cytokine activity within the framework of an observational and experimental research design will have implications for understanding the psycho-biological mechanisms that link sleep and the clinical manifestations of RA. Results from this study will guide the developments of interventions that target disordered sleep with potential effects on disability in RA.
Primary Outcome
Slow wave sleep in minutes at post-infusion day 2 in placebo vs. remicade
Conditions Studied
Interventions
- DRUG Remicade
Study Locations (1)
California
- University of California, Los Angeles, General Clinical Research Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-11 |
| Est. Completion | 2011-04 |
| Phase | NA |
What the finished NCT00948610 record still lists
NCT00948610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which Remicade is the first listed.
NCT00948610 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00948610 about?
NCT00948610 is a clinical study titled "Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy". More than half of rheumatoid arthritis (RA) patients complain of sleep disturbance and this cardinal complaint is associated with fatigue, pain, and depressed mood in patient with chronic inflammatory disorder. Despite the frequency of this complaint, there is limited efforts to evaluate sleep or th...
What is the current status of trial NCT00948610?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2008-11. Estimated completion is 2011-04.
What conditions does trial NCT00948610 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT00948610?
The interventions under investigation include: Remicade (DRUG).
Who is sponsoring clinical trial NCT00948610?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00948610 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00948610's enrollment target sits among peer trials
20 177th of 197 higher than 18 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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