Recruitment

Recruitment Status
Completed

Inclusion Criterias

Participants with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria.
Use of effective contraception throughout the study as defined by protocol; female participants of childbearing potential cannot be pregnant.
Oral corticosteroids (≤10 mg/day prednisone or equivalent), nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic DMARDs are permitted if on a stable dose regimen for greater than or equal to (≥]) 4 weeks prior to Baseline.
Participants with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria.
Use of effective contraception throughout the study as defined by protocol; female participants of childbearing potential cannot be pregnant.
Oral corticosteroids (≤10 mg/day prednisone or equivalent), nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic DMARDs are permitted if on a stable dose regimen for greater than or equal to (≥]) 4 weeks prior to Baseline.

Exclusion Criterias

Exposure to tocilizumab (either intravenous or SC) at any time prior to Baseline.
Presence of clinically significant medical conditions.
Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline.
...
Exposure to tocilizumab (either intravenous or SC) at any time prior to Baseline.
Presence of clinically significant medical conditions.
Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline.
Rheumatic autoimmune disease other than RA, including systemic lupus erythematosis, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjögren's syndrome with RA is permitted.
Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline.
Neuropathies or other conditions that might interfere with pain evaluation.
Any infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening.
Active tuberculosis requiring treatment within the previous 3 years.
Clinically significant findings on laboratory tests.
Diagnosis of juvenile idiopathic arthritis or juvenile RA, and/or RA before the age of 16 years.
Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
History of alcohol, drug, or chemical abuse within 1 year prior to Screening.
History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower gastrointestinal disease that might predispose to perforation.
Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections.
Functional Class IV as defined by the ACR Classification of Functional Status in RA.
Major surgery (including joint surgery) within 8 weeks prior to Screening or planned major surgery within 6 months following Baseline.
Positive hepatitis B surface antigen or hepatitis C antibody.
Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of Screening.
Prior history of or current inflammatory joint disease other than RA.
Evidence of active malignant disease, malignancies diagnosed within the previous 10 years, or breast cancer diagnosed within the previous 20 years.

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

Participants with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria.
Use of effective contraception throughout the study as defined by protocol; female participants of childbearing potential cannot be pregnant.
Oral corticosteroids (≤10 mg/day prednisone or equivalent), nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic DMARDs are permitted if on a stable dose regimen for greater than or equal to (≥]) 4 weeks prior to Baseline.
Participants with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria.
Use of effective contraception throughout the study as defined by protocol; female participants of childbearing potential cannot be pregnant.
Oral corticosteroids (≤10 mg/day prednisone or equivalent), nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic DMARDs are permitted if on a stable dose regimen for greater than or equal to (≥]) 4 weeks prior to Baseline.

Exclusion Criterias

Exposure to tocilizumab (either intravenous or SC) at any time prior to Baseline.
Presence of clinically significant medical conditions.
Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline.
...
Exposure to tocilizumab (either intravenous or SC) at any time prior to Baseline.
Presence of clinically significant medical conditions.
Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline.
Rheumatic autoimmune disease other than RA, including systemic lupus erythematosis, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjögren's syndrome with RA is permitted.
Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline.
Neuropathies or other conditions that might interfere with pain evaluation.
Any infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening.
Active tuberculosis requiring treatment within the previous 3 years.
Clinically significant findings on laboratory tests.
Diagnosis of juvenile idiopathic arthritis or juvenile RA, and/or RA before the age of 16 years.
Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
History of alcohol, drug, or chemical abuse within 1 year prior to Screening.
History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower gastrointestinal disease that might predispose to perforation.
Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections.
Functional Class IV as defined by the ACR Classification of Functional Status in RA.
Major surgery (including joint surgery) within 8 weeks prior to Screening or planned major surgery within 6 months following Baseline.
Positive hepatitis B surface antigen or hepatitis C antibody.
Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of Screening.
Prior history of or current inflammatory joint disease other than RA.
Evidence of active malignant disease, malignancies diagnosed within the previous 10 years, or breast cancer diagnosed within the previous 20 years.

Locations

Rotterdam, 3015 CE
Almelo, 7609 PP
Schiedam, 3118 JH
Haarlem, 2035 RC
Maastricht, 6202 ZA
...
Rotterdam, 3015 CE
Almelo, 7609 PP
Schiedam, 3118 JH
Haarlem, 2035 RC
Maastricht, 6202 ZA
Groningen, 9728 MG
Leeuwarden, 8934 AD
Apeldoorn, 7334 DZ
Amsterdam, 1056 AB
The Hague, 2545 CH
Heerlen, 6419 PC
Rotterdam, 3079 DZ
Sneek, 8601 ZK
Hoofddorp, 2134 TM
Dordrecht, 3318AT
Utrecht, 3584 GA
Groningen, 9700RB
Leiden, 2333 ZA
Breda, 4819 EV
The Hague, 2597 AX

Tracking Information

NCT #
NCT01987479
Collaborators
Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche