Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation (SURPRISE)
This study has been completed.
Sponsor:
SURPRISE Study Group
Information provided by (Responsible Party):
SURPRISE Study Group
ClinicalTrials.gov Identifier:
NCT01120366
First received: May 6, 2010
Last updated: January 23, 2015
Last verified: January 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Tocilizumab plus methotrexate Drug: Tocilizumab |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation |
Resource links provided by NLM:
Further study details as provided by SURPRISE Study Group:
Primary Outcome Measures:
- DAS28-ESR remission at 24 weeks [ Time Frame: at 24 week ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Step 2: Investigation of discontinuation
Secondary Outcome Measures:
- Change in TSS score [ Time Frame: at 52 weeks (after treatment initiation) ] [ Designated as safety issue: No ]Step 1
- Change of DAS28-ESR remission rate [ Time Frame: Week 0 to Week 52 ] [ Designated as safety issue: No ]Step 1
- Change of ACR response rate [ Time Frame: Week 0 to Week 52 ] [ Designated as safety issue: No ]Step 1
- EQ5D scores over time [ Time Frame: Week 0 to Week 52 ] [ Designated as safety issue: No ]Step 1
- J-HAQ/HAQ scores over time [ Time Frame: Week 0 to Week 52 ] [ Designated as safety issue: No ]Step 1
- SDAI, CDAI, and Boolean remission rates [ Time Frame: Week 0 to Week 52 ] [ Designated as safety issue: No ]Step 1
- TNF-α over time [ Time Frame: Week 0 to Week 52 ] [ Designated as safety issue: No ]Step 1
- Between-group comparison of the discontinuation rate after an achievement of remission [ Time Frame: Week 0 to Week 104 ] [ Designated as safety issue: No ]Step 2
- Factor analysis of patients maintaining discontinuation [ Time Frame: Week 0 to Week 104 ] [ Designated as safety issue: No ]Step 2
- Time course of DAS28 after restarting TCZ (between-group comparison) [ Time Frame: Week 52 to Week 104 ] [ Designated as safety issue: No ]Step 2
- Change in TSS score [ Time Frame: Week 52 to Week 104 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Step 2
- SDAI, CDAI, and Boolean remission rates [ Time Frame: Week 52 to Week 104 ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Adverse events [ Time Frame: During the study period ] [ Designated as safety issue: Yes ]
| Enrollment: | 233 |
| Study Start Date: | October 2009 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: SWITCH
Tocilizumab monotherapy
|
Drug: Tocilizumab
tocilizumab 8mg/kg/4weeks (i.v.) up to 52weeks.
Other Name: Actemra
|
|
Active Comparator: ADD-ON
Tocilizumab plus methotrexate combination
|
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:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120366
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| Responsible Party: | SURPRISE Study Group |
| ClinicalTrials.gov Identifier: | NCT01120366 History of Changes |
| Other Study ID Numbers: | SURPRISE Study, UMIN000002744 |
| Study First Received: | May 6, 2010 |
| Last Updated: | January 23, 2015 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Methotrexate Abortifacient Agents Abortifacient Agents, Nonsteroidal Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antirheumatic Agents Dermatologic Agents Enzyme Inhibitors |
Folic Acid Antagonists Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015