None listed
Conditions
Brief summary
This phase IIIb study will include adult patients, 18 years or older,body weight 150kg or less, with moderate to severe active rheumatoid arthritis (RA) of duration 6 months or more, who are inadequate responders to DMARDs or anti-TNF therapies. The primary objective is to assess the safety and tolerability of tocilizumab (TCZ) monotherapy or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs). The secondary objectives is to assess the efficacy of TCZ monotherapy or in combination with non-biologic DMARDs. The study is designed so that patients would be on the study for 24 weeks, receiving 6 x 60min infusions of TCZ every 4 weeks. AEs and other safety variables will be analyzed using descriptive statistics. Safety and study data will be collected on an electronic CRF.
Interventions
Tocilizumab 8mg/kg intra venously (IV), 60-minute infusion period, every 4 weeks for a total of 6 infusions
Sponsors
Roche Products Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Male or non-pregnant, non-nursing female 2.>/-18 years of age 3.Diagnosis of moderate to severe active RA (DAS28>/-3.2) of >/- 6months duration 4.Receiving treatment on an outpatient basis 5.Patients on >/-1 non-biologic DMARDs at a stable dose for a period </-8 weeks prior to treatment (Day1) 6. Patients with an inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy 7.If patients are receiving an oral corticosteroid, the dose must have been stable for at least 25 out of 28 days prior to treatment (Day1) 8.Able and willing to give written informed consent and comply with the requirements of the study protocol
Exclusion criteria
1.Major surgery (incl joint surgery) within 8weeks prior to screening or planned major surgery within 6months following randomisation 2.Rheumatic autoimmune disease other than RA (rheumatoid arthritis), including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA(rheumatoid arthritis) (e.g.vasculitis, pulmonary fibrosis or Felty's syndrome) Patient with interstitial pulmonary fibrosis and still able to tolerate MTX (methotrexate) therapy are permitted Sjorgen's Syndrome with RA (rheumatoid arthritis) is permitted 3. Functional Clas IV as defined by the ACR (American College of Rheumatology) Classification of Functional Status in RA (rheumatoid arthritis) (largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care) 4.Prior history of or current inflammatory joint disease other than RA (rheumatoid arthritis) (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropaty, Lyme disease) 5.Treatment with any investigational agent within 4weeks (or 5 half-lives of investigational agent, whichever is longer) before screening. 6.Previous treatment with any cell-depleting therapies, including investigational agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20) 7.Previous treatment with abatacept 8.Treatment with IV gamma globulin, plasmapheresis or Prosorba column within 6months before baseline 9.Intraarticular or parenteral corticosteroids within 6weeks prior to baseline 10.Immunization with a live/attenuated vaccine within 4weeks prior to baseline 11.Previous treatment with TCZ (Tocilizumab) (an exception to this criterion may be granted for single-dose exposure upon application to the sponsor on a case by case basis) 12.Any previous treatment with alkylating agents, such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation 13.Serum creatinine >142
Outcome results
None listed