UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016928 |
|---|---|
| Receipt number | R000019626 |
| Scientific Title | Targeted Ultrasound in Rheumatoid Arthritis |
| Date of disclosure of the study information | 2015/03/26 |
| Last modified on | 2020/09/28 09:56:58 |
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Basic information
Public title
Targeted Ultrasound in Rheumatoid Arthritis
Acronym
TURA
Scientific Title
Targeted Ultrasound in Rheumatoid Arthritis
Scientific Title:Acronym
TURA
Region
| Japan | Europe |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether therapy modifications can change synovial Doppler signals in patients with stable RA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients in whom there is a decrease in synovial Doppler signal at week 48 after randomization
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
If DAS28 increased by >0.6 from baseline, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week.
Interventions/Control_2
If DAS28 increased by >0.6 from baseline or total PD score is 4 or greater, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age 18 years old
2. Confirmed Participation by Informed Consent
3. Patients fulfilling the ACR/EULAR classification criteria 2010 for RA Patients must be:
4. Within the two years of starting on methotrexate AND
5. Within 5 years of diagnosis AND
6. In a stable clinical disease activity state (clinical remission/LDAS /other physician deemed state) on methotrexate (as monotherapy or combination +/- prednisolone 5mg oral daily) for at least 8 successive weeks before screening visit (with no change in DMARD +/- steroid therapy . see exclusion criteria).
7. Patients should be on an acceptable (maximal tolerated) MTX dose, which in the clinician's opinion, would justify escalation to adalimumab if a flare in disease activity occurs as detailed in the protocol.
8. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral /implantable hormonal contraceptives, intrauterine device or barrier and spermicide). Subjects must agree to use adequate contraception during the study and for at least 5 months after study completion (or longer if on relevant therapy and in line with local regulations). Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for at least 5 months after the end of the study period.
Key exclusion criteria
General
1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 12 months following randomisation.
2. Any persons that are committed to a psychiatric institution or in prison will be excluded from participation in this study.
Study Specific
3. Patients with a secondary, non-inflammatory musculoskeletal condition (e.g., osteoarthritis or fibromyalgia) that in the Investigator's opinion is symptomatic
4. enough to interfere with evaluation of the effect of study drug or the patient's primary diagnosis of RA.
5. Patients with a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis) or connective tissue diseases, e.g. primary Sjogren's syndrome, systemic sclerosis, systemic lupus erythematosus, polymyositis.
6. Patients not on a stable dose of methotrexate within 8 weeks of screening, intolerance or contraindications (as per clinician judgment)
7. Intramuscular, intra-articular or change in oral corticosteroid within 8 weeks of screening visit.
8. Oral Prednisolone dose > 5 mg within 8 weeks of screening
9. Unable to attend 12-weekly clinical assessments
10. Female patients who are breastfeeding, pregnant, or plan to become pregnant during the trial or within twelve weeks following completion of the study.
11. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
Excluded Previous or Concomitant Therapy:
12. Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening.
13. Patients who have previously received any biological therapy for RA.
14. Immunisation with a live/attenuated vaccine within 4 weeks prior to baseline.
15. Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Paul Emery |
Organization
Leeds University
Division name
Institute of Rheumatic & Musculoskeletal Medicine
Zip code
Address
2nd Floor, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, United Kingdom
TEL
+44-113-392-4884
p.emery@leeds.ac.uk
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Ito |
Organization
EPS Associate
Division name
Pharmaceutical Development Project Division
Zip code
Address
Kogin Bldg. 2F, 4-1-1 Koraibashi, Chuo-ku, Osaka, 541-0043, Japan
TEL
06-6202-5372
Homepage URL
m.ito.iy@eps-associates.com
Sponsor or person
Institute
Leeds University
Institute
Department
Personal name
Funding Source
Organization
Leeds University
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 03 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 26 | Day |
Last modified on
| 2020 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019626
