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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016928
Receipt No. R000019626
Scientific Title Targeted Ultrasound in Rheumatoid Arthritis
Date of disclosure of the study information 2015/03/26
Last modified on 2015/03/29

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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
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
Email 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
Email m.ito.iy@eps-associates.com

Sponsor
Institute Leeds University
Institute
Department

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
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
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
2015 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019626

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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