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Completed

NCT Number: NCT01120366

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hokkaido Medical Center for Rheumatic Diseases Hospital, Sapporo, Hokkaido, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tocilizumab plus methotrexate

Drug

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

Tocilizumab

Drug

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

Other names: Actemra

Primary outcomes

  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 outcomes

  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 outcomes

  1. Adverse events

    Time frame: During the study period

Sponsors and collaborators

Lead sponsor

SURPRISE Study Group

Network

Registry information

Acronym: SURPRISE

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
May 10, 2010
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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