UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000009535 |
| Receipt No. | R000011195 |
| Scientific Title | Suppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexate |
| Date of disclosure of the study information | 2012/12/12 |
| Last modified on | 2020/03/16 (Ver. 7) |
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| Basic information | ||
| Public title | Suppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexate | |
| Acronym | SCRUM study | |
| Scientific Title | Suppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexate | |
| Scientific Title:Acronym | SCRUM study | |
| Region |
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| Condition | ||
| Condition | rheumatoid arthritis | |
| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | In this study, we predict the progression of joint destruction by using the (US) ultrasound joint and analyze whether the joint destruction is suppressed by increasing methotrexate (MTX) in clinical remission with rheumatoid arthritis (RA) patients. |
| Basic objectives2 | Safety,Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | the change of X-ray from baseline in the van der Heijde-Sharp score at week 52 |
| Key secondary outcomes | the change of X-ray from baseline in the van der Heijde-Sharp score at week 24
the change of power doppler signal from baseline in the van der Heijde-Sharp score at week 24and 52 |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Parallel |
| Randomization | Randomized |
| Randomization unit | Individual |
| Blinding | Open -no one is blinded |
| Control | No treatment |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | ||
| No. of arms | 3 | |
| Purpose of intervention | Treatment | |
| Type of intervention |
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| Interventions/Control_1 | We randomly assigned patients who have the positive joint of power Doppler signal by ultrasonography even in clinical remission to increase or stable the dose of MTX and observation .
MTX increase group was increased to 16mg, it will continue to increase as much as possible. |
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| Interventions/Control_2 | We randomly assigned patients who have the positive joint of power Doppler signal by ultrasonography even in clinical remission to increase or stable the dose of MTX and observation .
MTX increase group was increased to 16mg, it will continue to increase as much as possible. |
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| Interventions/Control_3 | We observe the patients if there is no positive joint power Doppler signal. | |
| 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 |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | RA patients fulfiling the American Rheumatology Association criteria 1987 and ACR/EULAR classification cliteria 2010.
The patients who have stable remission and 28-joint disease activity score CRP (DAS28-CRP) <2.6 for at least 3 months. |
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| Key exclusion criteria | Patients who can not use oral MTX due to side effects.
Patients with other diseases that can affect the infllamation state. Patients who was deemed inappropriate by test doctor to participate in this study. |
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| Target sample size | 120 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Osaka City University Medical School | ||||||
| Division name | Orthopedic Surgery | ||||||
| Zip code | 545-8585 | ||||||
| Address | Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan | ||||||
| TEL | 0666453851 | ||||||
| ma1sa3ru@med.osaka-cu.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Osaka City University Medical School | ||||||
| Division name | Orthopedic Surgery | ||||||
| Zip code | 545-8585 | ||||||
| Address | Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan | ||||||
| TEL | 0666453851 | ||||||
| Homepage URL | |||||||
| ma1sa3ru@med.osaka-cu.ac.jp | |||||||
| Sponsor | |
| Institute | Osaka City University Medical School |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Self funding |
| 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 | Osaka City University Medical School |
| Address | Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan |
| Tel | 06-6645-3851 |
| ma1sa3ru@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 |
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| Related information | |
| URL releasing protocol | http://www.med.osaka-cu.ac.jp/orthoped/research/ |
| Publication of results | Unpublished |
| Result | |||||||
| URL related to results and publications | http://www.med.osaka-cu.ac.jp/orthoped/research/ | ||||||
| Number of participants that the trial has enrolled | 134 | ||||||
| Results | Clinical remission according to composite indexes allowed the presence of subclinical active synovitis that might induce structural joint damages. Subclinical active synovitis should be controlled by additional treatment and this results in the prevention of the joint damage progression. Evaluation of subclinical active synovitis by using high resolution US should be important even in patients achieving clinical remission and it should be treated more intensively if active synovitis is positive. |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Patients with RA in clinical remission defined as DAS (Disease activity score) 28-CRP<2.6. |
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| Participant flow | Provide informed consent directly to the selected patients and have them give their consent in a written consent form. |
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| Adverse events | Adverse events such as liver injury occurred in 15 patients, and the study was discontinued in this 15 patients |
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| Outcome measures | DAS28/US/mTSS |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Other | |
| Other related information | |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011195 |
