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Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation (SURPRISE)

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ClinicalTrials.gov Identifier: NCT01120366
Recruitment Status : Completed
First Posted : May 10, 2010
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
SURPRISE Study Group

Study Description
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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

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.

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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:
  • Actemra
  • Methotrexate


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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 :
  1. Change in TSS score [ Time Frame: at 52 weeks (after treatment initiation) ]
    Step 1

  2. Change of DAS28-ESR remission rate [ Time Frame: Week 0 to Week 52 ]
    Step 1

  3. Change of ACR response rate [ Time Frame: Week 0 to Week 52 ]
    Step 1

  4. EQ5D scores over time [ Time Frame: Week 0 to Week 52 ]
    Step 1

  5. J-HAQ/HAQ scores over time [ Time Frame: Week 0 to Week 52 ]
    Step 1

  6. SDAI, CDAI, and Boolean remission rates [ Time Frame: Week 0 to Week 52 ]
    Step 1

  7. TNF-α over time [ Time Frame: Week 0 to Week 52 ]
    Step 1

  8. Between-group comparison of the discontinuation rate after an achievement of remission [ Time Frame: Week 0 to Week 104 ]
    Step 2

  9. Factor analysis of patients maintaining discontinuation [ Time Frame: Week 0 to Week 104 ]
    Step 2

  10. Time course of DAS28 after restarting TCZ (between-group comparison) [ Time Frame: Week 52 to Week 104 ]
    Step 2

  11. Change in TSS score [ Time Frame: Week 52 to Week 104 ]
    Step 2

  12. 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

  13. SDAI, CDAI, and Boolean remission rates [ Time Frame: Week 52 to Week 104 ]

Other Outcome Measures:
  1. Adverse events [ Time Frame: During the study period ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
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.
Contacts and Locations
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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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:
Arthritis, Rheumatoid
Arthritis
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