An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy
NCT ID: NCT03155347
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
340 participants
INTERVENTIONAL
2017-08-02
2022-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tocilizumab + MTX
Participants will receive tocilizumab SC injections Q2W along with MTX orally every week (QW) for 24-week double-blind treatment phase. Participants who complete the 24-week double-blind treatment phase may continue treatment until Week 48 in the extension phase, irrespective if they achieve or do not achieve DAS28 low activity (DAS28-ESR \<= 3.2).
Tocilizumab
Participants will receive tocilizumab 162 mg given as 0.9 milliliter (mL) of a 180 mg/mL solution in a prefilled syringe, administered by SC injection Q2W.
MTX
Participants will receive MTX stable doses at 10 to 25 mg orally.
Tocilizumab + Placebo Matched to MTX
Participants will receive tocilizumab SC Q2W along with placebo matched to MTX for 24-week double-blind treatment phase. Participants who complete the 24-week double-blind treatment phase may continue treatment until Week 48 in the extension phase. In the extension phase up to Week 48, participants who achieve DAS28 low activity (DAS28-ESR \<= 3.2) will remain on the same treatment they received in double-blind phase. Participants who do not achieve DAS28-ESR \<= 3.2 will receive treatment with tocilizumab 162 mg SC Q2W + MTX from Week 26 to Week 48.
Tocilizumab
Participants will receive tocilizumab 162 mg given as 0.9 milliliter (mL) of a 180 mg/mL solution in a prefilled syringe, administered by SC injection Q2W.
MTX
Participants will receive MTX stable doses at 10 to 25 mg orally.
Placebo Matched to MTX
Placebo matched to MTX.
Placebo Matched to Tocilizumab + MTX
Participants will receive placebo matched to tocilizumab along with MTX orally QW for 24-week double-blind treatment phase. Participants who complete the 24-week double-blind treatment phase may continue treatment until Week 48 in the extension phase. In the extension phase up to Week 48, participants who achieve DAS28 low activity (DAS28-ESR \<= 3.2) will remain on the same treatment they received in double-blind phase. Participants who do not achieve DAS28-ESR \<= 3.2 will receive treatment with tocilizumab 162 mg SC Q2W + MTX from Week 26 to Week 48.
Tocilizumab
Participants will receive tocilizumab 162 mg given as 0.9 milliliter (mL) of a 180 mg/mL solution in a prefilled syringe, administered by SC injection Q2W.
MTX
Participants will receive MTX stable doses at 10 to 25 mg orally.
Placebo Matched to Tocilizumab
Placebo matched to tocilizumab.
Interventions
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Tocilizumab
Participants will receive tocilizumab 162 mg given as 0.9 milliliter (mL) of a 180 mg/mL solution in a prefilled syringe, administered by SC injection Q2W.
MTX
Participants will receive MTX stable doses at 10 to 25 mg orally.
Placebo Matched to MTX
Placebo matched to MTX.
Placebo Matched to Tocilizumab
Placebo matched to tocilizumab.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have discontinued etanercept (or YiSaiPu) for \>= 2 weeks, infliximab, certolizumab, golimumab, abatacept or adalimumab for \>= 8 weeks, anakinra for \>= 1 week prior to randomization
* Have received oral MTX at a stable dose for at least 12 weeks prior to baseline (MTX dose 10 to 25 mg) and experience of failing at least one non-biologic DMARD including MTX
* All treatment with non-biological DMARDs except MTX should be withdrawn at least 2 weeks prior to baseline (leflunomide for \>= 12 weeks or \>= 14 days after standard cholestyramine or activated charcoal washout, azathioprine for \>= 4 weeks)
* SJC \>= 6 (on the basis of 66 joint counts) and TJC \>= 8 (on the basis of 68 joint counts) at screening and baseline with at least 3 months of treatment with permitted DMARDs
* Participants must have either high sensitive CRP \>= 10 milligrams per liter (mg/L) or ESR \>=28 millimeters per hour (mm/hr) at screening
* Oral corticosteroids (\<=10 mg/day prednisone or equivalent) and nonsteroidal anti-inflammatory drug (NSAIDs; up to the maximum recommended dose per local standard of care) are permitted if the dose has been stable for at least 4 weeks prior to baseline
* All treatment with Chinese traditional medicine and/or herb medicine for RA treatment should be withdrawn at least 2 weeks prior to baseline
* Females of childbearing potential and males with female partners of childbearing potential may participate only if using a reliable means of contraception as defined by the protocol
Exclusion Criteria
* Participants with unsuccessful treatment with an anti-tumor necrosis factor (anti-TNF) agent; previous treatment with any cell-depleting therapies including investigational agents and janus kinase (JAK) inhibitors or any other new agents which have DMARD/DMARD-like effect; treatment with intravenous (IV) gamma-globulin, plasmapheresis, or Prosorba column; treatment with alkylating agents
* Intra-articular or parenteral corticosteroids and/or immunization with a live/attenuated vaccine within 4 weeks prior to baseline
* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
* Primary or secondary immunodeficiency (history of or currently active)
* Evidence of serious uncontrolled concomitant diseases and disease states; evidence of active malignant disease
* Participants with abnormal haematological parameters, abnormal renal and hepatic parameters
* Positive for either hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and/or hepatitis C virus (HCV) antibody
18 Years
70 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Baotou Medical College
Baotou, , China
China-Japan Friendship Hospital
Beijing, , China
Peking University First Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
Beijing Union Hospital
Beijing, , China
Affiliated Hospital of Bengbu Medical College
Bengbu, , China
the First Hospital of Jilin University
Changchun, , China
West China Hospital, Sichuan University
Chengdu, , China
Guangdong General Hospital
Guangzhou, , China
The 1st Affiliated Hospital of Harbin Medical University
Harbin, , China
The First Affiliated Hospital of Anhui Medical University
Hefei, , China
Affiliated Hospital of Inner Mongolia Medical College
Hohhot, , China
The First Hospital of Jiaxing
Jiaxing, , China
Qilu Hospital of Shandong University
Jinan, , China
The First Affilliated Hospital of Kunming Medical College
Kunming, , China
Jiangsu Province Hospital
Nanjing, , China
Pingxiang People Hospital
Pingxiang, , China
Shengjing Hospital of China Medical University
Shenyang, , China
The Second Hospital of Shanxi Medical University
Taiyuan, , China
Tianjin Medical University General Hospital
Tianjin, , China
Countries
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References
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Liu T, Wang L, Zhang X, Chen L, Liu Y, Jiang Z, Shuai Z, Zhang M, Wei W, Liu H, Xu J, Zhang Z, Wang G, Wang X, Hu J, Li H, Zhang Z, Wang H, Lu F, Du Y, Xue Z, Zhao Y, Li Z. Tocilizumab Monotherapy or Combined With Methotrexate for Rheumatoid Arthritis: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2511095. doi: 10.1001/jamanetworkopen.2025.11095.
Other Identifiers
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YA29359
Identifier Type: -
Identifier Source: org_study_id