Recruitment

Recruitment Status
Completed
Estimated Enrollment
150

Inclusion Criteria

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
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
Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate
Permitted non-biologic DMARDs allowed if at stable dose for >/=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

Exclusion Criteria

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

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

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
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
Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate
Permitted non-biologic DMARDs allowed if at stable dose for >/=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

Exclusion Criteria

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

Locations

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

Tracking Information

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