Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Product Name: Tocilizumab
Product Code: Ro 487-7533
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RoActemra
CAS Number: 375823-41-9
Current Sponsor code: Ro 487-7533
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or non-pregnant, non-nursing female 2.Age > 18 years 3.Patients currently experiencing moderate to severe active RA (DAS-28 > 3.2) at screening. 4.Patients receiving treatment on an outpatient basis 5.Patients that have responded inadequately to prior treatment with a stable dose (> 8 weeks) of non biologic DMARDs therapy 6.Oral corticosteroids and NSAIDs (up to the maximum recommended dose) are permitted if the dose has been stable for at least 4 weeks prior to baseline 7.Subjects able and willing to give written informed consent and comply with the requirements of the study protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Disease-specific criteria: 1. Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis or Felty?s syndrome). Patients with secondary Sjogren?s Syndrome associated with RA can be included in the study 2. Functional class IV as defined by the ACR Classification of Functional Status in RA (largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care) 3. History of or current inflammatory joint disease other than RA (including but limited to: tophaceous gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease, pseudogout, arthropathy of inflammatory bowel disease) Drug-specific criteria: 4. Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening 5. Previous treatment with an anti-TNF agent 6. Previous/concurrent treatment with any cell depleting therapies, including investigational agents (e.g. alemtuzumab, anti-CD4, anti-CD5, anti-CD3, anti-CD19) 7. Treatment with intravenous gamma globulin, plasmapharesis or Prosorba column within six months of baseline 8. Concurrent treatment with EPO 9. Immunization with a live/attenuated vaccine within 4 weeks prior to baseline 10. Any previous treatment with alkylating agents, such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation Laboratory-specific criteria (at screening): 11. Serum creatinine > 1.6 mg/dL (160 μmol/L) 12. ALT (SGPT) or AST (SGOT) > 1.5 ULN (if initial sample yields ALT [SGPT] or AST [SGOT] > 1.5 ULN, a second sample may be taken and tested during the screening period) 13. Platelet count 1.5 ULN (if initial sample yields bilirubin > 1.5 ULN, a second sample may be taken and tested during the screening period) 17. Triglycerides > 900 mg/dl at screen (non-fasted) 18. Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody General medical: 19. Pregnant women or nursing (breastfeeding) mothers 20. Females of child-bearing potential who are not using a reliable means of contraception 21. Intended major surgery within 8 weeks prior to screening or planned major joint surgery during the study 22. Body weight > 150 kg 23. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies 24. Evidence of significant and/or uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders 25. In patients with a history of diverticulitis or diverticulosis requiring antibiotic treatment, the treating physician needs to consider the benefit-risk ratio 26. A history of chronic ulcerative lower GI disease such as Crohn?s disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations 27. Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids Et al.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of tocilizumab in combination with non biologic DMARDs on anemia and fatigue over 6 months of treatment in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to non biologic DMARDs therapy.;Secondary Objective: 1.To assess the efficacy of tocilizumab in combination with non biologic DMARDs on signs and symptoms of RA (ACR responses and DAS-28); 2.To assess the effects of tocilizumab in combination with non biologic DMARDs on quality of life (HAQ) 3.To assess the cost-effectiveness of tocilizumab in combination with non biologic DMARDs (SF-HLQ) 4.To assess the tolerability and safety of tocilizumab in combination with non biologic DMARDs.;Primary end point(s): ASSESSMENTS OF EFFICACY Primary efficacy variables: 1. Changes from baseline of anemia, evaluated as change in Hb levels, at week 4 2. Changes from baseline of fatigue, evaluated as change in FACIT-Fatigue questionnaire, at week 4 ASSESSMENTS OF SAFETY 1. Standard adverse events (AEs), drug-related AEs, serious adverse events (SAEs) and study discontinuations due to AEs. ASSESSMENTS OF QUALITY OF LIFE 1. FACIT-Fatigue questionnaire 2. Changes from baseline in physical functioning, evaluated as change in Health Assessment Questionnaire (HAQ) | — |
Countries
Italy
Outcome results
None listed