Rheumatoid Arthritis Clinical Trial
Official title:
An Open-Label Study to Evaluate Non-Progression Of Structural Joint Damage Of Subcutaneous Tocilizumab In Patients With Moderate To Severe Active Rheumatoid Arthritis (Ac-Cute)
Verified date | July 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Australia: Therapeutic Goods Administration |
Study type | Interventional |
This open-label, single-arm study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active moderate to severe rheumatoid arthritis. Patients will receive a subcutaneous dose of RoActemra/Actemra 162 mg once weekly. The anticipated time on study treatment is 24 weeks.
Status | Completed |
Enrollment | 52 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients at least 18 years of age - Patients with a diagnosis of active moderate to severe rheumatoid arthritis (RA) - Oral corticosteroids and nonsteroidal anti-inflammatory are permitted if on a stable dose regimen for >/= 4 weeks prior baseline - Permitted non-biologic DMARDs used alone or in combination are allowed if at a 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 may participate in this study only if using a reliable means of contraception for at least 5 months following the last dose RoActemra/Actemra - Previous or current treatment with methotrexate with an inadequate response to methotrexate, intolerance to methotrexate or treatment with methotrexate was considered as inappropriate - Evidence of i or more erosions in hands or feet assessed by X-ray attribute to RA or MRI of wrist of MCP joints of dominant hand 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 - 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 current inflammatory joint disease other than RA - Exposure to RoActemra/Actemra 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-depleting therapies - Treatment with IV gamma globulin, plasmapheresis within 6 months of baseline - Intraarticular (IA) or parenteral corticosteroids within 4 weeks prior to baseline - Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation - Treatment with 2 or more anti-TNFs or any other biologic agent at any time prior to screening - Evidence of serious uncontrolled concomitant disease (e.g., cardiovascular, nervous system, pulmonary) - History of diverticulitis, diverticulosis requiring antibiotic treatment, or chromic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis, or other symptomatic lower GU conditions that might predispose to perforation - Known active current or history of recurrent infections |
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 |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absolute change in Genant-modified total Sharp score (mTSS) | From screening to Week 24 | No | |
Secondary | Change in Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) remission (defined as DAS28<2.6) | From baseline to Week 24 | No | |
Secondary | Change in American College of Rheumatology (ACR20/50/70) response | From baseline to Week 24 | No | |
Secondary | Change in European League Against Rheumatism (EULAR) Response | From baseline to Week 24 | No | |
Secondary | Change in Simplified Disease Activity Index (SDAI) | From baseline to Week 24 | No | |
Secondary | Change in Clinical Disease Activity Index (CDAI) | From baseline to Week 24 | No | |
Secondary | Change in total tender joint count (TJC) | From baseline to Week 24 | No | |
Secondary | Change in swollen joint count (SJC) | From baseline to Week 24 | No | |
Secondary | Change in Patient Reported Outcomes | From baseline to Week 24 | No | |
Secondary | Safety: Adverse events | 24 weeks | No | |
Secondary | Safety: Assessment of immunogenicity | 32 weeks | No | |
Secondary | Absolute change from baseline in rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS) scoring of erosions, synovitis, cartilage loss and osteitis. | From baseline to Week 24 | No |
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