A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of active rheumatoid arthritis according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria
- Oral corticosteroids (less than or equal to [</=] 10 milligrams per day [mg/day] prednisolone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs; up to the maximum recommended dose) are permitted if on a stable dose regimen for greater than or equal to [>/=] 4 weeks prior to baseline
- Permitted non biologic DMARDs are allowed if a stable dose for at least 4 weeks prior to baseline
- Receiving treatment on an outpatient basis, not including tocilizumab
- Females of childbearing potential and males with female partners of childbearing potential must agree to use a reliable means of contraception during the study; females of childbearing potential must use a reliable means of contraception for at least 3 month following the last dose of tocilizumab
Exclusion Criteria:
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
- Rheumatic autoimmune disease other than rheumatoid arthritis; secondary Sjögren's syndrome with rheumatoid arthritis is permitted
- Functional Class 4 as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
- Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16
- Prior history of or current inflammatory joint disease other than rheumatoid arthritis
- Participants with lack of peripheral venous access
- Exposure to tocilizumab (either intravenous [IV] or SC) at any time prior to baseline
- Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of screening
- Previous treatment with any cell-depending therapies
- Treatment with IV gamma globulin, plasmapheresis within 6 months of baseline
- Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
- Immunization with a live/attenuated vaccine within 4 weeks prior to baseline
- Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal disease
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections
- Any major episode of infection requiring hospitalization of treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
- Active tuberculosis (TB) requiring treatment within the previous 3 years
- Positive for hepatitis B surface antigen or hepatitis C antibody
- Primary or secondary immunodeficiency (history of or currently active)
- Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (except for basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured), or breast cancer diagnosed within the previous 20 years
- Pregnant or breast feeding women
- History of alcohol, drug or chemical abuse within 1 year prior to screening
- Neuropathies or other conditions that interfere with pain evaluation
Sites / Locations
- District Gen. Hosp. of Athens Laiko; A Propedeutic Internal Medicine Clinic & Research Center
- Laiko General Hospital; Dept. of Pathophysiology-Uni of Athens
- Hippokratio Hospital; 2Nd Internal Medicine
- ATTIKO Hospital_4th University Internal Medicine Clinic
- Uni General Hospital of Heraklion; Medicine and Rheumatology Clinical Immunology and Allergy Dept
- Uni Hospital of Ioannina; Rheumatology
- University General Hospital of Larissa; Rheumatology Unit
- University Hospital of Patras; Rheumatology
- EUROMEDICA Geniki Kliniki Thessalonikis; Rheumatology Department
- General Hospital of Thessaloniki HIPPOKRATIO; Clinical Immunology Unit,2nd Dept of Internal Medicine
Arms of the Study
Arm 1
Experimental
Tocilizumab
Participants will receive tocilizumab 162 milligrams (mg) SC injection once a week (QW) either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment is according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant may either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52. After Week 52, participants who remain in study will enter a 8 week wash-out period and then (from Week 60) will proceed to the extension phase until tocilizumab is commercially available in Greece. Permitted DMARDs include methotrexate, azathioprine, chloroquine, hydroxychloroquine, leflunomide, and sulfasalazine.