Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 226

Inclusion Criteria

- Age >= 18 years
- RA of >= 6 months duration diagnosed according to American College of Rheumatology (ACR)/European League against Rheumatology (EULAR) criteria
Track TCZ-experienced patients:
- Have received tocilizumab (TCZ) either subcutaneous (SC, 162 milligrams [mg] once a week [QW]) or intravenous (IV, 8 mg/kilogram [kg] every 4 weeks [Q4W]) for the treatment of RA for at least 24 weeks prior to randomization
- Have received 5- 15 mg/day of glucocorticoids (GCs) [prednisone or equivalent] for the treatment of RA for at least 20 weeks prior to screening
- Currently receiving 5 mg/day of prednisone
- Have attained and maintained LDA (DAS28 ESR score <=3.2) or remission (DAS28 ESR score <=2.6) for at least 4 weeks prior to randomization
Track TCZ-naïve patients:
- Have active RA (defined as DAS28 ESR score >3.2)
- Are considered by the investigator as inadequate responders to conventional synthetic disease-modifying antirheumatic drug (csDMARDs) or biologic disease-modifying antirheumatic drug (bDMARDs)
- Are receiving 5-15 mg/day prednisone (or equivalent) for the treatment of RA

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

- Major surgery (including joint surgery) within 8 weeks prior to screening, or planned major surgery during the study and up to 6 months after randomization
- Pregnant women or nursing (breastfeeding) mothers
- Body weight of >=150 kg
- RA of functional class IV, as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
- Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty syndrome). Secondary Sjögren syndrome with RA may be allowed per the discretion of the investigator
- Diagnosed with juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16 years
- Prior or current inflammatory joint disease other than RA (e.g., gout, Lyme disease, sero-negative spondyloarthropathy, including reactive arthritis, psoriatic arthritis, arthropathy of inflammatory bowel disease), or prior or current joint infections
- Previous history of primary or secondary adrenal insufficiency
- Intraarticular (IA) or parenteral GCs for the treatment of RA within 4 weeks prior to screening
- Previous treatment with GCs for conditions other than RA, at any dose and in any formulation used continuously for > 1 week, during the last 1 year prior to screening. Topical GC creams or ointments for the treatment of skin conditions (e.g. eczema) are allowed
- Immunization with a live/attenuated vaccine within 30 days prior to screening
- Any previous treatment with alkylating agents such as chlorambucil or with total lymphoid irradiation
- Inadequate hematological, renal and liver functions
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Evidence of current serious uncontrolled cardiovascular (including uncontrolled hyperlipidemia), nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or gastrointestinal (GI) disease
- Current liver disease as determined by the investigator
- History of diverticulitis, peptic ulcer disease, 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 perforations
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other opportunistic infections (including, but not limited to, tuberculosis [TB] and atypical mycobacterial disease, hepatitis B and C, Epstein-Barr virus, cytomegalovirus and herpes zoster, but excluding fungal infections of nail beds)
- Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation
- Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
- Active TB requiring treatment within the previous 3 years (patients previously treated for TB with no recurrence within 3 years are permitted). All TCZ-naïve patients must be screened for latent TB and if positive, should be treated following local practice guidelines prior to initiating TCZ
- History of or currently active, primary or secondary immunodeficiency
- Evidence of active ma

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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