UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the relationship between arthritis and sleep disturbance
Title of the study (Brief title)	Sleep study in arthritis
Region	Japan

Condition
Condition	Rheumatoid Arthritis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of arthritis on the sleep states of the patients with rheumatoid arthritis.To evaluate the effect of sleep states on the extent of arthritis in the patients with rheumatoid arthritis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Extent of the improvements in sleep states.
Key secondary outcomes	Extent of the improvements in arthritis scores.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Treatment with melatonin-mimetics, ramelteon. Treatment with biological disease-modifying anti-rheumatic drugs.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Treatment with melatonin-mimetic, ramelteon: 1. Rheumatoid patients over 20 yrs old, fulfilling the ACR2010 classification criteria. 2.Rheumatoid patients confirmable to have sleep difficulties. 3.Rheumatoid patiets with full consents. Treatment with biological DMARDs:1. Rheumatoid patients over 20 yrs old, fulfilling the ACR2010 classification criteria. 2.Rheumatoid patients with active diease requiring biologics. 3.Rheumatoid patiets with full consents.
Key exclusion criteria	1. Patients who experienced signifant or notable adverse events. 2. Patients who claimed to withdraw from the study.
Target sample size	200

Research contact person
Name of lead principal investigator	Shunichi Shiozawa
Organization	Kyushu University Beppu Hospital
Division name	Demartment of Medicine, Rheumatic Diseases Unit
Address	4546 Tsurumihara, Beppu
TEL	0977-27-1656
Email	shiozawa@beppu.kyushu-u.ac.jp

Public contact
Name of contact person	Shunichi Shiozawa
Organization	Kyushu University Beppu Hospital
Division name	Department of Medicine, Rheumatic Disease Unit
Address	4546 Tsurumihara, Beppu
TEL	0977-27-1656
Homepage URL
Email	shiozawa@beppu.kyushu-u.ac.jp

Sponsor
Institute	Shunichi Shiozawa
Institute
Department

Funding Source
Organization	Grant-in-aid for scientific study C
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Rheumatic Diseases Center, Kohnan Kakogawa Hospital
Name of secondary funｄer(s)	none

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 04 Day
Anticipated trial start date	2013 Year 12 Month 05 Day
Last follow-up date	2017 Year 03 Month 30 Day
Date of closure to data entry	2018 Year 02 Month 27 Day
Date trial data considered complete	2018 Year 02 Month 27 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 26 Day
Last modified on	2018 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021765