UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060596 |
|---|---|
| Receipt number | R000069304 |
| Scientific Title | Comparison of Romosozumab and Antiresorptive Therapy for Fragility Fractures in Patients with Rheumatoid Arthritis (CRAFT-RA Study) |
| Date of disclosure of the study information | 2026/02/19 |
| Last modified on | 2026/02/19 19:11:35 |
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Basic information
Public title
A Study to Evaluate the Effectiveness and Safety of Switching to Romosozumab in Patients with Rheumatoid Arthritis and Fragility Fractures
Acronym
RA Romosozumab Switch Study
Scientific Title
Comparison of Romosozumab and Antiresorptive Therapy for Fragility Fractures in Patients with Rheumatoid Arthritis (CRAFT-RA Study)
Scientific Title:Acronym
CRAFT-RA Study
Region
| Japan |
Condition
Condition
Rheumatoid arthritis with fragility fractures
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness and safety of switching from antiresorptive agents to romosozumab in patients with rheumatoid arthritis and a history of fragility fractures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of new fragility fractures at 104 weeks after switching to romosozumab
Key secondary outcomes
1. Timing of Fracture Occurrence
Incidence of new fragility fractures at 26, 52, and 78 weeks after switching to romosozumab
2. Bone Metabolism and Bone Mass Changes
Changes in bone turnover markers (TRAP-5b and total P1NP) at baseline, 52 weeks, and 104 weeks
Percentage changes in bone mineral density of the lumbar spine and proximal femur at the same time points
3. Safety Outcomes
Incidence of cardiovascular events (myocardial infarction, stroke, etc.)
Incidence of osteonecrosis of the jaw
Incidence of injection site reactions and hypersensitivity (allergic reactions)
Incidence of infections
Incidence of malignancies
4. Rheumatoid Arthritis Disease Activity
Changes in disease activity assessed by CDAI
Changes in antirheumatic medications
5. Comparative Evaluation with Non-RA Osteoporosis Patients
Non-RA osteoporosis patients will be used as the control group to evaluate fracture incidence, changes in bone turnover markers, bone mineral density, and safety outcomes after switching to romosozumab.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible patients must meet all of the following criteria:
1. Male or female patients aged 50 years or older
2. Patients diagnosed with rheumatoid arthritis according to the ACR/EULAR classification criteria, or patients with non-rheumatoid arthritis osteoporosis
3. Patients who meet the diagnostic criteria for osteoporosis and have a history of fragility fractures
4. Patients who have been receiving antiresorptive therapy (denosumab or bisphosphonates) for at least 6 months
5. Patients who have provided written informed consent after receiving sufficient explanation of the study
6. Patients who are able to attend regular outpatient visits and undergo scheduled evaluations during the study period
Key exclusion criteria
Patients meeting any of the following criteria will be excluded from this study:
1. Patients with a history of treatment with bone-forming agents (teriparatide, abaloparatide, etc.)
2. Patients with connective tissue diseases other than rheumatoid arthritis (in the non-rheumatoid arthritis group)
3. Patients currently receiving denosumab or bisphosphonates as bone-modifying agents for the prevention or treatment of skeletal-related events associated with malignancy
4. Patients with a history of severe cardiovascular events, such as myocardial infarction or stroke, within one year prior to enrollment
5. Patients with a history of osteonecrosis of the jaw or active jaw lesions
6. Patients judged by the principal investigator to be inappropriate for participation in this study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Shunichi |
| Middle name | |
| Last name | Fujita |
Organization
Kawasaki Medical School
Division name
Department of rheumatology
Zip code
7100016
Address
577 Matsushima, Kurashiki city, Okayama, Japan
TEL
086-462-1111
shunichi@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Shunichi |
| Middle name | |
| Last name | Fujita |
Organization
Kawasaki Medical School
Division name
Department of Rheumatology
Zip code
7010192
Address
577 Matsushima, Kurashiki city, Okayama, Japan
TEL
086-462-1111
Homepage URL
shunichi@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School
Address
577 Matsushima, Kurashiki city, Okayama, Japan
Tel
086-462-1111
shunichi@med.kawasaki-m.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
| 2026 | Year | 02 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study designed to generate real-world evidence regarding the effectiveness and safety of switching to romosozumab for the treatment of osteoporosis in patients with rheumatoid arthritis. Currently, limited data are available on the use of romosozumab in patients with rheumatoid arthritis, particularly concerning long-term outcomes after switching from antiresorptive agents. In this study, treatment selection is determined by patients and attending physicians under routine clinical practice, and no specific therapeutic intervention is assigned by the study protocol. This design enables evaluation of treatment outcomes in real-world clinical settings. In addition, non-rheumatoid arthritis osteoporotic patients are enrolled as a control group to assess the impact of rheumatoid arthritis-specific disease characteristics on treatment effectiveness and safety. As this is a non-randomized observational study, potential confounding factors related to patient background characteristics will be addressed using appropriate statistical adjustment methods, such as propensity score analyses. All collected data will be managed under the supervision of the principal investigator, with strict measures implemented to ensure data quality and the protection of personal information. The results of this study will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals, with the aim of contributing to the optimization of osteoporosis treatment strategies in patients with rheumatoid arthritis.
Management information
Registered date
| 2026 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069304
