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CompletedNCT01120366SURPRISEUpdated Jan 26, 2015

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

A Phase 4 interventional study of Tocilizumab plus methotrexate and Tocilizumab in Rheumatoid Arthritis, sponsored by SURPRISE Study Group. Completed at 30 sites in Japan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-01-26.

Sponsored by SURPRISE Study Group · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
233
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 233 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

This is the only study on the registry with SURPRISE Study Group as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
233 participants (actual)

Study arms

  • Active comparator
    SWITCH

    Tocilizumab monotherapy

    Drug: Tocilizumab

  • Active comparator
    ADD-ON

    Tocilizumab plus methotrexate combination

    Drug: Tocilizumab plus methotrexate

Interventions

  • DrugTocilizumab 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.

    Also known as: Actemra, Methotrexate

  • DrugTocilizumab

    tocilizumab 8mg/kg/4weeks (i.v.) up to 52weeks.

    Also known as: Actemra

06

What researchers measure

Primary outcomes

  1. DAS28-ESR remission at 24 weeks

    Step 1: Investigation of the efficacy and safety of TCZ in combination therapy with MTX

    Time frame: at 24 week

  2. Changes over time in the number of patients maintaining discontinuation (maintenance rate)

    Step 2: Investigation of discontinuation

    Time frame: Week 52 to Week 104

Secondary outcomes

  1. Change in TSS score

    Step 1

    Time frame: at 52 weeks (after treatment initiation)

  2. Change of DAS28-ESR remission rate

    Step 1

    Time frame: Week 0 to Week 52

  3. Change of ACR response rate

    Step 1

    Time frame: Week 0 to Week 52

  4. EQ5D scores over time

    Step 1

    Time frame: Week 0 to Week 52

  5. J-HAQ/HAQ scores over time

    Step 1

    Time frame: Week 0 to Week 52

  6. SDAI, CDAI, and Boolean remission rates

    Step 1

    Time frame: Week 0 to Week 52

  7. TNF-α over time

    Step 1

    Time frame: Week 0 to Week 52

  8. Between-group comparison of the discontinuation rate after an achievement of remission

    Step 2

    Time frame: Week 0 to Week 104

  9. Factor analysis of patients maintaining discontinuation

    Step 2

    Time frame: Week 0 to Week 104

  10. Time course of DAS28 after restarting TCZ (between-group comparison)

    Step 2

    Time frame: Week 52 to Week 104

  11. Change in TSS score

    Step 2

    Time frame: Week 52 to Week 104

  12. Time course of DAS28 after restarting MTX following suspension of discontinuation in the TCZ monotherapy group in Step 1

    Step 2

    Time frame: Week 52 to Week 104

  13. SDAI, CDAI, and Boolean remission rates

    Time frame: Week 52 to Week 104

Other outcomes

  1. Adverse events

    Time frame: During the study period

07

Study locations

30 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 31106666 ↗
  • 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. PubMed 29853455 ↗
  • 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. PubMed 26733110 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01120366
Lead sponsor
SURPRISE Study Group
Responsible party
Sponsor
First posted
May 10, 2010
Start date
Oct 2009
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jan 26, 2015

Study contacts

Tsutomu Takeuchi
principal investigator · Keio University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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