An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Tocilizumab (RoActemra/Actemra) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
Overall contact: Reference Study ID Number: ML28703 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com
Summary
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.
Clinical Details
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)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Absolute change in Genant-modified total Sharp score (mTSS)
Secondary outcome: Change in Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) remission (defined as DAS28<2.6)Change in American College of Rheumatology (ACR20/50/70) response Change in European League Against Rheumatism (EULAR) Response Change in Simplified Disease Activity Index (SDAI) Change in Clinical Disease Activity Index (CDAI) Change in total tender joint count (TJC) Change in swollen joint count (SJC) Change in Patient Reported Outcomes Safety: Adverse events Safety: Assessment of immunogenicity Absolute change from baseline in rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS) scoring of erosions, synovitis, cartilage loss and osteitis.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Reference Study ID Number: ML28703 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com
Camperdown, New South Wales 2050, Australia; Completed
Coffs Harbour, New South Wales 2450, Australia; Active, not recruiting
Kogarah, New South Wales 2217, Australia; Completed
Southport, Queensland 4215, Australia; Completed
Adelaide, South Australia 5000, Australia; Completed
Hobart, Tasmania 7000, Australia; Completed
Geelong, Victoria 3220, Australia; Active, not recruiting
Ivanhoe, Victoria 3079, Australia; Completed
Malvern East, Victoria 3145, Australia; Recruiting
Morwell, Victoria 3842, Australia; Completed
Additional Information
Starting date: November 2013
Last updated: August 17, 2015
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