Rheumatoid Arthritis Clinical Trial
Official title:
An Open-label, Single Arm Study to Evaluate the Efficacy and Safety and Tolerability of Tocilizumab (TCZ) Subcutaneous in TCZ-naïve Patients With Active Rheumatoid Arthritis
This open-label, single-arm study will evaluate the efficacy and safety of subcutaneously administered RoActemra/Actemra (tocilizumab) in monotherapy and/or in combination with methotrexate and other non-biologic DMARDs in patients with active rheumatoid arthritis who are naïve to RoActemra/Actemra. Patients will receive RoActemra/Actemra 162 mg subcutaneously weekly for 24 weeks. Patients who complete the core study achieving at least a moderate EULAR response at Week 24 may enter the extension phase and receive RoActemra/Actemra for a further 28 weeks at the most.
Status | Completed |
Enrollment | 57 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients, >/= 18 years of age - Active moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria - Inadequate response or intolerant to previous therapy with two or more non-biologic disease-modifying anti-rheumatic drugs (DMARDs), one of which is methotrexate, administered in an optimal way during at least 3 months; eligible patients may also be inadequate responders to a maximum of one biologic DMARD - Oral corticosteroids (</= 10 mg/day prednisolone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs; up to the recommended dose) are permitted if on stable dose regimen for >/= 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 RoActemra/Actemra - Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception as defined by protocol Exclusion Criteria: - Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline or during LTE period - Rheumatic autoimmune disease other than rheumatoid arthritis - Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid 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 the investigational 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 murine monoclonal 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 IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening - Active 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Belgium, Luxembourg,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Disease Activity Score 28 - erythrocyte sedimentation rate (DAS28-ESR) score | from baseline to Week 24 | No | |
Secondary | Change in American College of Rheumatology (ACR) response scores | from baseline to Week 24 | No | |
Secondary | Change in European League Against Rheumatism (EULAR) response criteria | from baseline to Week 24 | No | |
Secondary | Change in Simplified Disease Activity Index (SDAI)/Clinical Disease Activity Index (CDAI) | from baseline to Week 24 | No | |
Secondary | Change in total tender/swollen joint count (TJC/SJC) | from baseline to Week 24 | No | |
Secondary | Proportion of patients with corticosteroid dose reduction/discontinuation | 24 weeks | No | |
Secondary | Percentage of patients achieving low disease activity, defined as DAS28 </= 3.2, CDAI </= 10.0, SDAI </= 11.0 | 24 weeks | No | |
Secondary | Percentage of patients achieving remission, defined as DAS28 </= 2.6, CDAI </= 2.8, SDAI </=3.3 | 24 weeks | No | |
Secondary | Percentage of patients achieving a clinically significant improvement in DAS28 (reduction of at least 1.2 units) | 24 weeks | No | |
Secondary | Percentage of patients with major or minor improvement in SDAI/CDAI | 24 weeks | No | |
Secondary | Safety: Incidence of adverse events | up to 60 weeks | No | |
Secondary | Safety: Incidence of anti-tocilizumab antibodies | up to 60 weeks | No | |
Secondary | Patient reported quality of life (Questionnaires: HAQ-DI, FACIT-F, PSQI, AIMS-SF, TSQM, RA-WIS, Visual Analogue Scales) | 24 weeks | No |
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