Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation (SURPRISE)
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| ClinicalTrials.gov Identifier: NCT01120366 |
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Recruitment Status :
Completed
First Posted : May 10, 2010
Last Update Posted : January 26, 2015
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Sponsor:
SURPRISE Study Group
Information provided by (Responsible Party):
SURPRISE Study Group
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis | Drug: Tocilizumab plus methotrexate Drug: Tocilizumab | Phase 4 |
In this study, we aim to prospectively and randomly evaluate efficacy for changes in clinical remission and joint destruction in RA patients in treatment with TCZ monotherapy(SWITCH) and in combination therapy with MTX(ADD-ON), and also to investigate the best therapeutic approach to achieve discontinuation.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 233 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation |
| Study Start Date : | October 2009 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | December 2014 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Rheumatoid arthritis
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: SWITCH
Tocilizumab monotherapy
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Drug: Tocilizumab
tocilizumab 8mg/kg/4weeks (i.v.) up to 52weeks.
Other Name: Actemra |
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Active Comparator: ADD-ON
Tocilizumab plus methotrexate combination
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Drug: 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.
Other Names:
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Primary Outcome Measures :
- DAS28-ESR remission at 24 weeks [ Time Frame: at 24 week ]Step 1: Investigation of the efficacy and safety of TCZ in combination therapy with MTX
- Changes over time in the number of patients maintaining discontinuation (maintenance rate) [ Time Frame: Week 52 to Week 104 ]Step 2: Investigation of discontinuation
Secondary Outcome Measures :
- Change in TSS score [ Time Frame: at 52 weeks (after treatment initiation) ]Step 1
- Change of DAS28-ESR remission rate [ Time Frame: Week 0 to Week 52 ]Step 1
- Change of ACR response rate [ Time Frame: Week 0 to Week 52 ]Step 1
- EQ5D scores over time [ Time Frame: Week 0 to Week 52 ]Step 1
- J-HAQ/HAQ scores over time [ Time Frame: Week 0 to Week 52 ]Step 1
- SDAI, CDAI, and Boolean remission rates [ Time Frame: Week 0 to Week 52 ]Step 1
- TNF-α over time [ Time Frame: Week 0 to Week 52 ]Step 1
- Between-group comparison of the discontinuation rate after an achievement of remission [ Time Frame: Week 0 to Week 104 ]Step 2
- Factor analysis of patients maintaining discontinuation [ Time Frame: Week 0 to Week 104 ]Step 2
- Time course of DAS28 after restarting TCZ (between-group comparison) [ Time Frame: Week 52 to Week 104 ]Step 2
- Change in TSS score [ Time Frame: Week 52 to Week 104 ]Step 2
- Time course of DAS28 after restarting MTX following suspension of discontinuation in the TCZ monotherapy group in Step 1 [ Time Frame: Week 52 to Week 104 ]Step 2
- SDAI, CDAI, and Boolean remission rates [ Time Frame: Week 52 to Week 104 ]
Other Outcome Measures:
- Adverse events [ Time Frame: During the study period ]
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| Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Major exclusion criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120366
Locations
| Japan | |
| 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 | |
| Bunkyo-ku, 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 | |
| Kitakyusyu, 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 | |
| Oita, 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 | |
Sponsors and Collaborators
SURPRISE Study Group
Investigators
| Principal Investigator: | Tsutomu Takeuchi | Keio University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | SURPRISE Study Group |
| ClinicalTrials.gov Identifier: | NCT01120366 History of Changes |
| Other Study ID Numbers: |
SURPRISE Study UMIN000002744 ( Other Identifier: UMIN ) |
| First Posted: | May 10, 2010 Key Record Dates |
| Last Update Posted: | January 26, 2015 |
| Last Verified: | January 2015 |
Additional relevant MeSH terms:
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |