UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000980 |
|---|---|
| Receipt number | 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 | 2020/07/19 18:17:17 |
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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 | 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
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
tatsuya@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Orthopaedic surgery, Osaka city university graduated school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001153
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
