Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Body weight \</=150 kg
Active moderate to severe rheumatoid arthritis (DAS28 \>/=4.4) according to the revised 1987 ACR criteria at screening and baseline (prior to treatment on Day 1)
Currently receiving oral MTX for at least 24 weeks and on a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1), with the following exception: a stable dose of at least 10 mg/week is allowed for participants with a body weight \<50 kg or calculated glomerular filtration rate (or creatinine clearance) \<60 milliliters per minute (mL/min)
History of parenteral (SC or intramuscular \[IM\]) MTX is allowed, but not within 6 weeks prior to treatment (Day 1). Participants must not have a documented, clinically significant intolerance to oral MTX and must be receiving oral MTX at a dose of 15 mg/week for at least 6 weeks prior to treatment (Day 1)
Participants who have received one prior anti-tumor necrosis factor (TNF) must have discontinued etanercept, infliximab, certolizumab, adalimumab, or golimumab for at least 6 months prior to screening
Oral corticosteroids must have been \</=10 mg/day prednisone (or equivalent) and stable for at least 25 out of 28 days prior to treatment (Day 1)
Participants receiving treatment on an outpatient basis
You may not be if
Documented medical history of significant intolerance to oral MTX \>/=15 mg/week
Participants receiving other (non-MTX) disease modifying anti-rheumatic drugs (DMARDs) within 8 weeks of screening
Previous treatment with abatacept, rituximab, tofacitinib, or anakinra
Treatment with parenteral corticosteroids within 4 weeks prior to treatment
Previous treatment with cell-depleting therapies or alkylating agents
Previous treatment with TCZ
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery during the study
Rheumatic autoimmune disease other than rheumatoid arthritis
Non-rheumatic active autoimmune diseases (for example, inflammatory bowel diseases, psoriasis, multiple sclerosis)
Prior history of or current inflammatory joint disease other than rheumatoid arthritis
Functional Class IV according to the revised (1987) ACR criteria for rheumatoid arthritis
History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
Evidence of significant uncontrolled concomitant diseases; uncontrolled disease states where flares are commonly treated with oral or parenteral corticosteroids
Active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening
Active tuberculosis requiring treatment within the previous 3 years
History of or currently active primary or secondary immunodeficiency
Pregnant or breast-feeding women
Positive for hepatitis B or hepatitis C infection
For potential MRI substudy participants: the presence of any metal-containing device or object in the body
Clareo Health | A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX
