Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation
NCT ID: NCT01120366
Last Updated: 2015-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
233 participants
INTERVENTIONAL
2009-10-31
2014-12-31
Brief Summary
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Furthermore, in patients who have been able to achieve control of disease activity via the above therapy, we investigate the possibility of stopping TCZ and verify safety when TCZ is restarted after disease recurrence.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SWITCH
Tocilizumab monotherapy
Tocilizumab
tocilizumab 8mg/kg/4weeks (i.v.) up to 52weeks.
ADD-ON
Tocilizumab plus methotrexate combination
Tocilizumab plus methotrexate
Tocilizumab 8mg/kg 4weeks (i.v.) plus methotrexate up to 52weeks.The dosage of MTX will be fixed at least 24 weeks from the start of the study.
Interventions
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Tocilizumab plus methotrexate
Tocilizumab 8mg/kg 4weeks (i.v.) plus methotrexate up to 52weeks.The dosage of MTX will be fixed at least 24 weeks from the start of the study.
Tocilizumab
tocilizumab 8mg/kg/4weeks (i.v.) up to 52weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 20 to 75 years inclusive at enrolment (within 2 weeks before starting treatment with the investigational drug)
* Treated with MTX at ≥6 mg/week for at least 8 weeks immediately before enrolment
* Rheumatoid arthritis of duration ≤10 years
* DAS28-ESR ≥3.2 (within 2 weeks before starting treatment with the investigational drug)
* Having received and thoroughly understood an adequate explanation about participation in the study, patients who have personally and voluntarily provided written informed consent
Exclusion Criteria
* Patients who received leflunomide within 12 weeks, DMARDs other than MTX within 8 weeks , or tacrolimus within 4 weeks before the 1st TCZ infusion.
* Patients who previously received biologic DMARDs including TCZ.
20 Years
75 Years
ALL
No
Sponsors
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SURPRISE Study Group
NETWORK
Responsible Party
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Principal Investigators
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Tsutomu Takeuchi
Role: PRINCIPAL_INVESTIGATOR
Keio University
Locations
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Hokkaido Medical Center for Rheumatic Diseases Hospital
Sapporo, Hokkaido, Japan
Utazu Hama Clinic
Ayautagun, , Japan
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Bunkyō City, , Japan
Fukushima Red-Cross Hospital
Fukushima, , Japan
Higashihiroshima Memorial Hospital
Higashihiroshima, , Japan
Tokyo Dental College Ichikawa General Hospital
Ichikawa, , Japan
Itabashi Medical Center
Itabashi-ku, , Japan
Shimane University Faculty of Medicine
Izumo, , Japan
Saitama Medical Center, Saitama Medical University
Kawagoe, , Japan
Kagawa University
Kida-gun, , Japan
University of Occupational and Environmental Health Hospital
Kitakyushu, , Japan
Kurashiki Sweet Hospital
Kurashiki, , Japan
Kyoto University Graduate School of Medicine
Kyoto, , Japan
Marunouchi Hospital
Matsumoto, , Japan
Dogo Spa Hospital
Matsuyama, , Japan
Zenjinkai Shimin-no-mori Hospital
Miyazaki, , Japan
Nagasaki University Graduate School of Biomedical Sciences
Nagasaki, , Japan
National Hospital Organization Nagoya Medical Center
Nagoya, , Japan
Niigata University Graduate School of Medical and Dental Sciences
Niigata, , Japan
Department of Internal Medicine, Hyogo College of Medicine
Nishinomiya, , Japan
Oribe Rheumatism and Internal Medicine Clinic
Ōita, , Japan
Hokkaido University Graduate School of Medicine
Sapporo, , Japan
Sasebo Chuo Hospital
Sasebo, , Japan
Niigata Rheumatic Center
Shibata, , Japan
Osaka University Hospital
Suita, , Japan
Institute of Rheumatology, Tokyo Women's Medical University
Tokyo, , Japan
Keio University Hospital
Tokyo, , Japan
The University of Tokyo Graduate School of Medicine
Tokyo, , Japan
Tomishiro Chuo Hospital
Tomishiro, , Japan
Yokohama Minami Kyousai Hospital
Yokohama, , Japan
Countries
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References
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Kato M, Kaneko Y, Tanaka Y, Inoo M, Kobayashi-Haraoka H, Amano K, Miyata M, Murakawa Y, Yasuoka H, Hirata S, Nagasawa H, Tanaka E, Miyasaka N, Yamanaka H, Yamamoto K, Yokota I, Atsumi T, Takeuchi T. Predictive value of serum amyloid a levels for requirement of concomitant methotrexate in tocilizumab initiation: A post hoc analysis of the SURPRISE study. Mod Rheumatol. 2020 May;30(3):442-449. doi: 10.1080/14397595.2019.1621026. Epub 2019 Jun 7.
Kaneko Y, Kato M, Tanaka Y, Inoo M, Kobayashi-Haraoka H, Amano K, Miyata M, Murakawa Y, Yasuoka H, Hirata S, Tanaka E, Miyasaka N, Yamanaka H, Yamamoto K, Takeuchi T; SURPRISE study group. Tocilizumab discontinuation after attaining remission in patients with rheumatoid arthritis who were treated with tocilizumab alone or in combination with methotrexate: results from a prospective randomised controlled study (the second year of the SURPRISE study). Ann Rheum Dis. 2018 Sep;77(9):1268-1275. doi: 10.1136/annrheumdis-2018-213416. Epub 2018 May 31.
Kaneko Y, Atsumi T, Tanaka Y, Inoo M, Kobayashi-Haraoka H, Amano K, Miyata M, Murakawa Y, Yasuoka H, Hirata S, Nagasawa H, Tanaka E, Miyasaka N, Yamanaka H, Yamamoto K, Takeuchi T. Comparison of adding tocilizumab to methotrexate with switching to tocilizumab in patients with rheumatoid arthritis with inadequate response to methotrexate: 52-week results from a prospective, randomised, controlled study (SURPRISE study). Ann Rheum Dis. 2016 Nov;75(11):1917-1923. doi: 10.1136/annrheumdis-2015-208426. Epub 2016 Jan 5.
Other Identifiers
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UMIN000002744
Identifier Type: OTHER
Identifier Source: secondary_id
SURPRISE Study
Identifier Type: -
Identifier Source: org_study_id
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