UMIN-CTR Clinical Trial

Basic information
Public title	Prospective cohort study of cervical and lumbar spinal lesion in patients with rheumatoid arthritis
Acronym	Analysis of Factors for RA Spinal Disorders study (AFFORD study)
Scientific Title	Prospective cohort study of cervical and lumbar spinal lesion in patients with rheumatoid arthritis
Scientific Title:Acronym	Analysis of Factors for RA Spinal Disorders study (AFFORD study)
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to prospectively investigate the occurence of spinal lesion in patients with rheumatoid arthritis and analyze the influence of the treatment for the spinal lesion.
Basic objectives2	Others
Basic objectives -Others	In addition to arthritis in extremity, spinal lesion often observed in patient with rheumatoid arthritis. The purpose of this study is to prospectively investigate the occurence of spinal lesion in patients with rheumatoid arthritis and analyze the influence of the treatment for the spinal lesion.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Spinal instability, the degenerative change in disc and vertebra, saggital or coronal alignment, neurological symptom, neck pain, back pain, shoulder stiffness
Key secondary outcomes	neural compression (MRI), degeneration of facet or endplate (MRI)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	the patient with Rheumatoid arthritis followed in our hospital who consent to this study.
Key exclusion criteria	Not applicable
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Tatsuya Middle name Last name Koike
Organization	Osaka city university graduated school of medicine
Division name	Dept. of orthopaedic surgery
Zip code	545-8585
Address	1-4-3 Asahimachi Abeno-ku Osaka city, Osaka, Japan
TEL	06-6645-3984
Email	tatsuya@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Tatsuya Middle name Last name Koike
Organization	Osaka city university graduated school of medicine
Division name	Dept. of orthopaedic surgery
Zip code	545-8585
Address	1-4-3 Asahimachi Abeno-ku Osaka city, Osaka, Japan
TEL	06-6645-3984
Homepage URL
Email	tatsuya@med.osaka-cu.ac.jp

Sponsor
Institute	Department of Orthopaedic surgery, Osaka city university graduated school of medicine
Institute
Department

Funding Source
Organization	Department of Orthopaedic surgery, Osaka city university graduated school of medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Department of Orthopaedic surgery, Osaka city university graduated school of medicine
Address	1-4-3 Asahimachi
Tel	0666453851
Email	a-suzuki@msic.med.osaka-cu.ac.jp

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	2009 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2008 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date	2008 Year 06 Month 01 Day
Last follow-up date	2018 Year 08 Month 01 Day
Date of closure to data entry	2019 Year 08 Month 01 Day
Date trial data considered complete	2020 Year 08 Month 01 Day
Date analysis concluded	2021 Year 12 Month 01 Day

Other
Other related information	morbidity of spinal lesion in patient with rheumatoid arthritis, and the correlation between the treatment and the morbidity

Management information
Registered date	2008 Year 01 Month 09 Day
Last modified on	2020 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001153