Phase
Condition
Rheumatoid Arthritis
Arthritis And Arthritic Pain
Dermatomyositis (Connective Tissue Disease)
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult participants, >/= 18 years of age
Active moderate to severe rheumatoid arthritis according to the revised (1987)American College of Rheumatology (ACR) criteria or EULAR/ACR (2010) criteria
Inadequate response or intolerant to previous therapy with two or more non-biologicdisease-modifying anti-rheumatic drugs (DMARDs), one of which is methotrexate,administered in an optimal way during at least 3 months; eligible participants mayalso be inadequate responders to a maximum of one biologic DMARD
Oral corticosteroids (/= 4 weeks prior to baseline
Permitted DMARDs are allowed if at 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 childbearingpotential must agree to use reliable means of contraception as defined by protocol
Exclusion
Exclusion Criteria:
Major surgery (including joint surgery) within 8 weeks prior to screening or plannedmajor surgery within 6 months following baseline or during long term extension (LTE)period
Rheumatic autoimmune disease other than rheumatoid arthritis
Functional Class IV as defined by the ACR Classification of Functional Status inRheumatoid Arthritis
Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
Prior history of or current inflammatory joint disease other than RA
Exposure to tocilizumab (intravenous or subcutaneous) at any time prior to baseline
Treatment with any investigational agent within 4 weeks (or 5 half-lives of theinvestigational drug, whichever is longer) of screening
Intraarticular or parenteral corticosteroids within 4 weeks prior to baseline
History of severe allergic or anaphylactic reactions to human, humanized or murinemonoclonal antibodies
Evidence of serious concomitant disease or disorder
Known active current or history of recurrent infection
Any major episode of infection requiring hospitalization or treatment with IVantibiotics within 4 weeks of screening or oral antibiotics within 2 weeks ofscreening
Active Tuberculosis (TB) requiring treatment within the previous 3 years
Positive for hepatitis B or hepatitis C
Primary or secondary immunodeficiency (history of or currently active)
Pregnant or lactating women
Neuropathies or other conditions that might interfere with pain evaluation
Inadequate hematologic, renal or liver function
Study Design
Connect with a study center
Aalst, 9300
BelgiumSite Not Available
Assebroek, 8310
BelgiumSite Not Available
Bonheiden, 2820
BelgiumSite Not Available
empty
Bouge, 5004
BelgiumSite Not Available
Bruxelles, 1020
BelgiumSite Not Available
Genk, 3600
BelgiumSite Not Available
Gent, 9000
BelgiumSite Not Available
empty
Gilly, 6060
BelgiumSite Not Available
Gilly (Charleroi), 6000
BelgiumSite Not Available
Gosselies, 6041
BelgiumSite Not Available
Haine-Saint-Paul, 7100
BelgiumSite Not Available
empty
Haine-St-Paul, 7100
BelgiumSite Not Available
empty
Ixelles, 1050
BelgiumSite Not Available
empty
Kortrijk, 8500
BelgiumSite Not Available
empty
Liege, 4000
BelgiumSite Not Available
Liège, 4000
BelgiumSite Not Available
Roeselare, 8800
BelgiumSite Not Available
Sijsele, 8340
BelgiumSite Not Available
empty
Sijsele-Damme, 8340
BelgiumSite Not Available
Sint-Niklaas, 9100
BelgiumSite Not Available
Wilrijk, 2610
BelgiumSite Not Available
Luxembourg, 2763
LuxembourgSite Not Available
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