Recruitment

Recruitment Status
Completed
Estimated Enrollment
150

Inclusion Criterias

Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
Receiving treatment on an outpatient basis, not including tocilizumab
Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline
...
Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
Receiving treatment on an outpatient basis, not including tocilizumab
Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline
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
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 Criterias

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

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 Criterias

Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
Receiving treatment on an outpatient basis, not including tocilizumab
Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline
...
Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
Receiving treatment on an outpatient basis, not including tocilizumab
Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline
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
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 Criterias

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

Locations

Jyväskylä, 40620
Lappeenranta, 53130
Odense, 5000
Holbæk, 4300
Glostrup, 2600
...
Jyväskylä, 40620
Lappeenranta, 53130
Odense, 5000
Holbæk, 4300
Glostrup, 2600
Oslo, 0370
Hyvinkää, 05800
Linkoeping, 58185
Oulu, 90220
Bergen, 5053
Ålesund, 6017
Hellerup, 2900
Helsinki, 00290
Svendborg, 5700
Jönköping, 551 85
Lund, 221 85
Køge, 4600
Trondheim, 7030
Drammen, 3004
Alborg, 9000
Simrishamn, 272 81
Uppsala, 75185
Oerebro, 70185
Västerås, 72189
Malmo, 205 02
Joensuu, 80210
Stockholm, 171 76

Tracking Information

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