Recruitment

Recruitment Status
Completed
Estimated Enrollment
150

Inclusion Criteria

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
Agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential
...
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
Agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential
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
Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline
Receiving treatment on an outpatient basis, not including tocilizumab

Exclusion Criteria

Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
Inadequate hematologic, renal, or liver function
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
...
Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
Inadequate hematologic, renal, or liver function
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
Neuropathies or other conditions that might interfere with pain evaluation
Pregnant or lactating women
Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
Prior history of or current inflammatory joint disease other than RA
Active tuberculosis requiring treatment within the previous 3 years
Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
Known active current or history of recurrent infection
Rheumatic autoimmune disease other than RA
Evidence of serious concomitant disease or disorder
History of or current active primary or secondary immunodeficiency
History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
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
Positive for hepatitis B or hepatitis C
Exposure to tocilizumab or any other biologic DMARDs at any time prior to baseline
Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) 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

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
Agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential
...
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
Agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential
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
Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline
Receiving treatment on an outpatient basis, not including tocilizumab

Exclusion Criteria

Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
Inadequate hematologic, renal, or liver function
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
...
Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
Inadequate hematologic, renal, or liver function
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
Neuropathies or other conditions that might interfere with pain evaluation
Pregnant or lactating women
Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
Prior history of or current inflammatory joint disease other than RA
Active tuberculosis requiring treatment within the previous 3 years
Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
Known active current or history of recurrent infection
Rheumatic autoimmune disease other than RA
Evidence of serious concomitant disease or disorder
History of or current active primary or secondary immunodeficiency
History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
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
Positive for hepatitis B or hepatitis C
Exposure to tocilizumab or any other biologic DMARDs at any time prior to baseline
Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening

Tracking Information

NCT #
NCT02046616
Collaborators
Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche