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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000004412 |
Receipt No. | R000005270 |
Scientific Title | Corticosteroid-sparing effect of Actemra in patients with Rheumatoid Arthritis refractory to anti-TNF agents, methotrexate and corticosteroid |
Date of disclosure of the study information | 2010/10/20 |
Last modified on | 2010/10/19 |
Basic information | ||
Public title | Corticosteroid-sparing effect of Actemra in patients with Rheumatoid Arthritis refractory to anti-TNF agents, methotrexate and corticosteroid
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Acronym | CARAT study | |
Scientific Title | Corticosteroid-sparing effect of Actemra in patients with Rheumatoid Arthritis refractory to anti-TNF agents, methotrexate and corticosteroid
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Scientific Title:Acronym | CARAT 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 | To test the possibility to reduce dosage of prednisolone (PSL) of less than 5mg/day with low disease activity in DAS28 by switching anti-TNF agents to tocilizumab in RA patients refractory to anti-TNF agents, MTX and PSL of more than 5mg/day with moderate or high diseae activity in DAS28. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Proportion of patients with less than 5mg/day in observation period. |
Key secondary outcomes | In observation period,
1. proportion of patients free from PSL 2. proportion of patients with recurrent RA after tapering PSL dosage 3. proporiton of patients with less than 2.6 of DAS28 4. proportion of patients with less than 5mg/day of PSL to be maintained 5. proportion of improvement of mHAQ 6. severe adverse events |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | tocilizumab | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Fulfill the RA classification criteria of American College of Rheumatology 1987.
2. More than 3.2 of DAS28-ESR. 3. Aged 16 to 80 years at registration. 4. PSL of 5 to 15mg/day in average is given and PSL of more 1mg/day in average has not been tapered for three months. 5. Both an anti-TNF agent and methotrexate of 4mg/week are given for more than 14weeks. 6. Written informed consent. |
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Key exclusion criteria | 1. Be against the guideline of tocilizumab use by Japanese College of Rheumatology.
2. Infliximab dosage is more than 6mg/kg or administration interval of infliximab is within 6weeks. 3. Be true of class 4 in Steinblocker functional class within four weeks before tocilizumab administration. 4. Has been treated with tocilizumab so far. 5. PSL is increased in its dosage or newly administered within 2weeks before administration of tocilizumab. 6. Patients to whom the following treatments are administered within 4weeks before tocilizumab administration: Newly use or increase in dose of DMARDs or immunosuppressive agents except for methotrexate. Plasma exchange including leukocytapheresis. Surgery such as total knee joint replacement which seems to have an influence on the evaluation of efficacy of tocilizumab. 7. Be pregnant or possible to be pregnant. 8. Have a past medical history of malignancy within 5years. 9. More than three times of ALT levels as high as standard in our institution. |
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Target sample size | 25 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tenri Hospital | ||||||
Division name | General Internal Medicine | ||||||
Zip code | |||||||
Address | 200, Mishima-cho, Tenri, Nara | ||||||
TEL | 0743-63-5611 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Tenri Hospital | ||||||
Division name | General Internal Medicine | ||||||
Zip code | |||||||
Address | 200, Mishima-cho, Tenri, Nara | ||||||
TEL | +81-743-63-5611 | ||||||
Homepage URL | |||||||
tazuma@tenriyorozu.jp |
Sponsor | |
Institute | General Internal Medicine, Tenri Hospital |
Institute | |
Department |
Funding Source | |
Organization | Tenri Hospital |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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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 | 天理よろづ相談所病院(奈良県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Management information | |||||||
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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=R000005270 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |