Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT01120366
- Lead Sponsor
- SURPRISE Study Group
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 233
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SWITCH Tocilizumab Tocilizumab monotherapy ADD-ON Tocilizumab plus methotrexate Tocilizumab plus methotrexate combination
- Primary Outcome Measures
Name Time Method DAS28-ESR remission at 24 weeks at 24 week 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) Week 52 to Week 104 Step 2: Investigation of discontinuation
- Secondary Outcome Measures
Name Time Method Change in TSS score Week 52 to Week 104 Step 2
Change of ACR response rate Week 0 to Week 52 Step 1
EQ5D scores over time Week 0 to Week 52 Step 1
SDAI, CDAI, and Boolean remission rates Week 52 to Week 104 Between-group comparison of the discontinuation rate after an achievement of remission Week 0 to Week 104 Step 2
Time course of DAS28 after restarting TCZ (between-group comparison) Week 52 to Week 104 Step 2
Change of DAS28-ESR remission rate Week 0 to Week 52 Step 1
J-HAQ/HAQ scores over time Week 0 to Week 52 Step 1
TNF-α over time Week 0 to Week 52 Step 1
Factor analysis of patients maintaining discontinuation Week 0 to Week 104 Step 2
Time course of DAS28 after restarting MTX following suspension of discontinuation in the TCZ monotherapy group in Step 1 Week 52 to Week 104 Step 2
Trial Locations
- Locations (30)
Utazu Hama Clinic
🇯🇵Ayautagun, Japan
Hokkaido Medical Center for Rheumatic Diseases Hospital
🇯🇵Sapporo, Hokkaido, 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
Kagawa University
🇯🇵Kida-gun, Japan
Saitama Medical Center, Saitama Medical University
🇯🇵Kawagoe, 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
Nagasaki University Graduate School of Biomedical Sciences
🇯🇵Nagasaki, Japan
Zenjinkai Shimin-no-mori Hospital
🇯🇵Miyazaki, 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
Osaka University Hospital
🇯🇵Suita, Japan
Niigata Rheumatic Center
🇯🇵Shibata, Japan
Institute of Rheumatology, Tokyo Women's Medical University
🇯🇵Tokyo, Japan
Keio University Hospital
🇯🇵Tokyo, Japan
Tomishiro Chuo Hospital
🇯🇵Tomishiro, Japan
The University of Tokyo Graduate School of Medicine
🇯🇵Tokyo, Japan
Yokohama Minami Kyousai Hospital
🇯🇵Yokohama, Japan