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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000000980
Receipt No. R000001153
Scientific Title Prospective cohort study of cervical and lumbar spinal lesion in patients with rheumatoid arthritis
Date of disclosure of the study information 2009/06/01
Last modified on 2017/08/19

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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
Middle name
Last name Tatsuya Koike
Organization Osaka city university graduated school of medicine
Division name Dept. of orthopaedic surgery
Zip code
Address 1-4-3 Asahimachi Abeno-ku Osaka city, Osaka, Japan
TEL 06-6645-3984
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Koike
Organization Osaka city university graduated school of medicine
Division name Dept. of orthopaedic surgery
Zip code
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
Address
Tel
Email

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
2017 Year 08 Month 19 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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