Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation
SURPRISE
2 other identifiers
interventional
233
1 country
30
Brief Summary
The objective of this study is to investigate the efficacy and safety of the humanized anti-human IL-6 receptor monoclonal antibody tocilizumab (TCZ) either in monotherapy or in combination therapy with methotrexate (MTX) in patients with an inadequate response to treatment with MTX. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 rheumatoid-arthritis
Started Oct 2009
Longer than P75 for phase_4 rheumatoid-arthritis
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 6, 2010
CompletedFirst Posted
Study publicly available on registry
May 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 26, 2015
January 1, 2015
5.2 years
May 6, 2010
January 23, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
DAS28-ESR remission at 24 weeks
Step 1: Investigation of the efficacy and safety of TCZ in combination therapy with MTX
at 24 week
Changes over time in the number of patients maintaining discontinuation (maintenance rate)
Step 2: Investigation of discontinuation
Week 52 to Week 104
Secondary Outcomes (13)
Change in TSS score
at 52 weeks (after treatment initiation)
Change of DAS28-ESR remission rate
Week 0 to Week 52
Change of ACR response rate
Week 0 to Week 52
EQ5D scores over time
Week 0 to Week 52
J-HAQ/HAQ scores over time
Week 0 to Week 52
- +8 more secondary outcomes
Other Outcomes (1)
Adverse events
During the study period
Study Arms (2)
SWITCH
ACTIVE COMPARATORTocilizumab monotherapy
ADD-ON
ACTIVE COMPARATORTocilizumab plus methotrexate combination
Interventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosed with RA in accordance with the 1987 classification criteria of ACR
- 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
You may not qualify if:
- Patients who were Steinbrocker Class IV.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
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
Related Publications (3)
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.
PMID: 31106666DERIVEDKaneko 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.
PMID: 29853455DERIVEDKaneko 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.
PMID: 26733110DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tsutomu Takeuchi
Keio University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2010
First Posted
May 10, 2010
Study Start
October 1, 2009
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 26, 2015
Record last verified: 2015-01