A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 150
Inclusion Criteria
- Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline
- Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate
- Moderate to severe RA with a DAS28-ESR score >3.2 points
- ...
- Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline
- Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate
- Moderate to severe RA with a DAS28-ESR score >3.2 points
- Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
- Receiving treatment on an outpatient basis, not including tocilizumab
- Oral corticosteroids (less than or equal to [</=] 10 mg per day prednisolone or equivalent) and nonsteroidal anti-inflammatory drugs (NSAIDs) permitted if on stable dose regimen for greater than or equal to [>/=] 4 weeks prior to baseline
- Agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential
Exclusion Criteria
- Inadequate hematologic, renal, or liver function
- Active tuberculosis requiring treatment within the previous 3 years
- Known active current or history of recurrent infection
- ...
- Inadequate hematologic, renal, or liver function
- Active tuberculosis requiring treatment within the previous 3 years
- Known active current or history of recurrent infection
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Prior history of or current inflammatory joint disease other than RA
- Rheumatic autoimmune disease other than RA
- Neuropathies or other conditions that might interfere with pain evaluation
- Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
- Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
- Pregnant or lactating women
- Positive for hepatitis B or hepatitis C
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
- Evidence of serious concomitant disease or disorder
- Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
- History of or current active primary or secondary immunodeficiency
- Exposure to tocilizumab or any other biologic DMARDs at any time prior to baseline
- Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
Summary
- Conditions
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Inclusion Criteria
- Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline
- Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate
- Moderate to severe RA with a DAS28-ESR score >3.2 points
- ...
- Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline
- Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate
- Moderate to severe RA with a DAS28-ESR score >3.2 points
- Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
- Receiving treatment on an outpatient basis, not including tocilizumab
- Oral corticosteroids (less than or equal to [</=] 10 mg per day prednisolone or equivalent) and nonsteroidal anti-inflammatory drugs (NSAIDs) permitted if on stable dose regimen for greater than or equal to [>/=] 4 weeks prior to baseline
- Agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential
Exclusion Criteria
- Inadequate hematologic, renal, or liver function
- Active tuberculosis requiring treatment within the previous 3 years
- Known active current or history of recurrent infection
- ...
- Inadequate hematologic, renal, or liver function
- Active tuberculosis requiring treatment within the previous 3 years
- Known active current or history of recurrent infection
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Prior history of or current inflammatory joint disease other than RA
- Rheumatic autoimmune disease other than RA
- Neuropathies or other conditions that might interfere with pain evaluation
- Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
- Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
- Pregnant or lactating women
- Positive for hepatitis B or hepatitis C
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
- Evidence of serious concomitant disease or disorder
- Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
- History of or current active primary or secondary immunodeficiency
- Exposure to tocilizumab or any other biologic DMARDs at any time prior to baseline
- Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
Tracking Information
- NCT #
- NCT02046616
- Collaborators
- Not Provided
- Investigators
- Study Director: Clinical Trials Hoffmann-La Roche
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