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Rheumatoid ArthritisPhase 4SURPRISENCT01120366

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

A Phase 4 study testing Tocilizumab plus methotrexate and Tocilizumab in people with Rheumatoid Arthritis, run by SURPRISE Study Group at 30 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Tocilizumab plus methotrexate and Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
233 participants
Where
30 sitesJapan
Study dates
Oct 2009to Dec 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Japan30 sites

  • Utazu Hama Clinic

    Ayautagun

  • Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

    Bunkyō City

  • Fukushima Red-Cross Hospital

    Fukushima

  • Higashihiroshima Memorial Hospital

    Higashihiroshima

  • Tokyo Dental College Ichikawa General Hospital

    Ichikawa

  • Shimane University Faculty of Medicine

    Izumo

  • Saitama Medical Center, Saitama Medical University

    Kawagoe

  • Kagawa University

    Kida-gun

  • University of Occupational and Environmental Health Hospital

    Kitakyushu

  • Kurashiki Sweet Hospital

    Kurashiki

  • Kyoto University Graduate School of Medicine

    Kyoto

  • Marunouchi Hospital

    Matsumoto

  • Dogo Spa Hospital

    Matsuyama

  • Zenjinkai Shimin-no-mori Hospital

    Miyazaki

  • Nagasaki University Graduate School of Biomedical Sciences

    Nagasaki

  • National Hospital Organization Nagoya Medical Center

    Nagoya

  • Niigata University Graduate School of Medical and Dental Sciences

    Niigata

  • Department of Internal Medicine, Hyogo College of Medicine

    Nishinomiya

  • Oribe Rheumatism and Internal Medicine Clinic

    Ōita

  • Hokkaido Medical Center for Rheumatic Diseases Hospital

    Sapporo, Hokkaido

  • Hokkaido University Graduate School of Medicine

    Sapporo

  • Sasebo Chuo Hospital

    Sasebo

  • Niigata Rheumatic Center

    Shibata

  • Osaka University Hospital

    Suita

  • Itabashi Medical Center

    tabashi City

  • Institute of Rheumatology, Tokyo Women's Medical University

    Tokyo

  • Keio University Hospital

    Tokyo

  • The University of Tokyo Graduate School of Medicine

    Tokyo

  • Tomishiro Chuo Hospital

    Tomishiro

  • Yokohama Minami Kyousai Hospital

    Yokohama

Other trials in Japan

About this study

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.

Being tested
Tocilizumab plus methotrexate, Tocilizumab
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tocilizumab plus methotrexateDrug

    Also called Actemra, 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.

  • TocilizumabDrug

    Also called Actemra

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

Study groups in NCT01120366
Study groupRoleWhat they receive
SWITCHActive comparatorTocilizumab monotherapy
Receives: Drug: Tocilizumab
ADD-ONActive comparatorTocilizumab plus methotrexate combination
Receives: Drug: Tocilizumab plus methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DAS28-ESR remission at 24 weeks

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

    Measured: at 24 week

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

    Step 2: Investigation of discontinuation

    Measured: Week 52 to Week 104

Secondary outcomes (13)

  1. Change in TSS score

    Step 1

    Measured: at 52 weeks (after treatment initiation)

  2. Change of DAS28-ESR remission rate

    Step 1

    Measured: Week 0 to Week 52

  3. Change of ACR response rate

    Step 1

    Measured: Week 0 to Week 52

  4. EQ5D scores over time

    Step 1

    Measured: Week 0 to Week 52

  5. J-HAQ/HAQ scores over time

    Step 1

    Measured: Week 0 to Week 52

  6. SDAI, CDAI, and Boolean remission rates

    Step 1

    Measured: Week 0 to Week 52

  7. TNF-α over time

    Step 1

    Measured: Week 0 to Week 52

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

    Step 2

    Measured: Week 0 to Week 104

  9. Factor analysis of patients maintaining discontinuation

    Step 2

    Measured: Week 0 to Week 104

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

    Step 2

    Measured: Week 52 to Week 104

  11. Change in TSS score

    Step 2

    Measured: 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

    Measured: Week 52 to Week 104

  13. SDAI, CDAI, and Boolean remission rates

    Measured: Week 52 to Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2010 (estimated)
  2. Study startOct 2009
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01120366
Sponsor's protocol ID
SURPRISE Study
Other IDs
UMIN000002744
Acronym
SURPRISE
Status last verified
Jan 2015
First submitted
6 May 2010
Last updated
26 Jan 2015
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tocilizumab plus methotrexate and Tocilizumab in people with Rheumatoid Arthritis, run by SURPRISE Study Group at 30 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DAS28-ESR remission at 24 weeks (time frame: at 24 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01120366, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015.

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