Recruitment

Recruitment Status
Completed
Estimated Enrollment
150

Inclusion Criteria

Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
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
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
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
Moderate to severe RA with a DAS28-ESR score >3.2 points
Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate
Receiving treatment on an outpatient basis, not including tocilizumab
Agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential
Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline

Exclusion Criteria

Known active current or history of recurrent infection
Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
...
Known active current or history of recurrent infection
Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
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
Active tuberculosis requiring treatment within the previous 3 years
History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
Exposure to tocilizumab or any other biologic DMARDs at any time prior to baseline
Inadequate hematologic, renal, or liver function
Positive for hepatitis B or hepatitis C
Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
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
Prior history of or current inflammatory joint disease other than RA
History of or current active primary or secondary immunodeficiency
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
Rheumatic autoimmune disease other than RA
Neuropathies or other conditions that might interfere with pain evaluation

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

Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
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
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
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
Moderate to severe RA with a DAS28-ESR score >3.2 points
Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate
Receiving treatment on an outpatient basis, not including tocilizumab
Agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential
Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline

Exclusion Criteria

Known active current or history of recurrent infection
Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
...
Known active current or history of recurrent infection
Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
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
Active tuberculosis requiring treatment within the previous 3 years
History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
Exposure to tocilizumab or any other biologic DMARDs at any time prior to baseline
Inadequate hematologic, renal, or liver function
Positive for hepatitis B or hepatitis C
Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
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
Prior history of or current inflammatory joint disease other than RA
History of or current active primary or secondary immunodeficiency
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
Rheumatic autoimmune disease other than RA
Neuropathies or other conditions that might interfere with pain evaluation

Tracking Information

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