MULTI-CENTER, OPEN LABEL, SINGLE ARM PHASE IIIB STUDY ON SAFETY AND EFFICACY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO NON-BIOLOGIC DMARDS
- Conditions
- RArheumatoid arthritis1000381610023213
- Registration Number
- NL-OMON38533
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Patients must meet the following criteria for study entry:;1. Able and willing to give written informed consent and comply with the requirements of the study protocol.;2. Patients at least 18 years of age.;3. Patients with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria.;4. Oral corticosteroids (<=10 mg/day prednisone or equivalent) and NSAIDs (up to the maximum recommended dose) are permitted if on a stable dose regimen for >=4 weeks prior to Baseline.;5. Permitted non-biologic DMARDs are allowed if at a stable dose for at least 4 weeks prior to Baseline.;6. Receiving treatment on an outpatient basis, not including TCZ.;7. Females of childbearing potential and males with female partners of childbearing potential may participate in this study only if using a reliable means of contraception (e.g., physical barrier [patient or partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device) during the study and for at least 3 months following the last dose of TCZ.;8. If female of childbearing potential, the patient must have a negative pregnancy test at the Screening and Baseline visits.;9. Patients that are conventional DMARD inadequate responders (IR), or are biological DMARD-IR with a maximum of an inadequate response to not more than one biological DMARD.;10. Have moderate to severe RA (DAS28 >= 3.2, >= 1 swollen joint).
A patient will be excluded if the answer to any of the following statements is *yes*:;General:;1. Major surgery (including joint surgery) within 8 weeks prior to Screening or planned major surgery within 6 months following baseline.;2. 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.;3. Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis.;4. Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16.;5. Prior history of or current inflammatory joint disease other than RA (e.g., gout, Lyme disease, seronegative spondyloarthropathy including reactive arthritis, psoriatic arthritis, and arthropathy of inflammatory bowel disease).;6. Patients with lack of peripheral venous access.;Excluded Previous or Concomitant Therapy:;7. Exposure to TCZ (either intravenous [IV] or SC) at any time prior to Baseline.;8. Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of Screening.;9. Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples are CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti CD19, and anti-CD20.;10. Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline.;11. Treatment with more than one biologic DMARD;12. Intraarticular or parenteral corticosteroids within 4 weeks prior to Baseline.;13. Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline.;14. Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation.;Exclusions for General Safety:;15. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.;16. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal (GI) disease.;17. History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower GI disease such as Crohn*s disease, ulcerative colitis, or other symptomatic lower GI conditions that might predispose to perforation.;18. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis [TB] and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds).;19. Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening.;20. Active TB requiring treatment within the previous 3 years. Patients should be screened for latent TB and, if positive, treated following local practice guidelines prior to initiating TCZ. Patients treated for TB with no recurrence in 3 years are permitted.;21. Current liver disease as determined by the Investigator.;22. Positive hepatitis B surface antigen or hepatitis C antibody.;23. Primary or secondary immunodeficiency (history of or currently active).;24. Evidence of active malignant disease, malignancies diagnosed within
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method