Rheumatoid arthritis. MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Product Name: Actemra
Product Code: RO4877533 (TCZ)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
Current Sponsor code: RO4877533
Concentration unit: mg/m
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-nursing female 2. = 18 years of age 3. Diagnosis of active RA of = 6 months duration and moderate to severe disease activity defined as DAS28 > 3.2 at screening 4. Receiving treatment on an outpatient basis 5. Patients on = 1 non-biologic DMARDs and/or anti-TNF therapy (see section 6.1) at a stable dose for a period = 8 weeks at any time prior to treatment (baseline) 6. Patients with 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 (baseline) 8. 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 1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment 2. Rheumatic autoimmune disease other than RA, Sjögren’s Syndrome with RA is permitted 3. Functional class IV as defined by the ACR Classification of Functional Status 4. Prior history of or current inflammatory joint disease other than RA Drug-specific 5. Treatment with any investigational agent or with anakinera, calcineurin inhibitors, mycophenolate, mofetil or mycophenolic acid within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening 6. Previous treatment with any cell-depleting therapies 7. Previous treatment with abatacept 8. Treatment with leuflunomide in combination with MTX. 9. Treatment with IV gamma globulin, plasmapheresis or Prosorba® column within 6 months before baseline 10. Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline 11. Immunization with a live/attenuated vaccine within 4 weeks prior to baseline 12. Previous treatment with TCZ (exception may be granted for single-dose exposure on a case by case basis) 13. Any previous treatment with alkylating agents Laboratory analyses (at screening) 14. Serum creatinine > 124 µmol/L (1.4 mg/dL) in female patients and > 141 µmol/L (1.6 mg/dL) in male patients 15. 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) 16. Platelet count ULN (If initial sample yields bilirubin > ULN, a second sample may be taken and tested during the screening period) 22. Triglycerides > 10 mmol/L (> 900 mg/dL) at screening (non-fasted) General medical 23. Pregnant women or nursing (breastfeeding) mothers 24. Females of child-bearing potential who are not using a reliable means of contraception, e.g. physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or IUD 25. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies 26. CXR evidence of any clinically significant abnormality 27. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or GI disease 28. In patients with a history of diverticulitis or diverticulosis requiring antibiotic treatment, the treating physician needs to consider the benefit-risk ratio 29. 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 30. Uncontrolled disease states where flares are commonly treated with oral or parenteral corticosteroids 31. Current liver disease as determined by principal investigator. Patients with prior history of ALT (SGPT) elevation are not excluded 32. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, clinically significant abnormalities on CXR as determined by the investig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the safety and tolerability of tocilizumab (TCZ) monotherapy or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active RA ;Secondary Objective: • To assess the efficacy of TCZ monotherapy or in combination with non-biologic DMARDs ;Primary end point(s): • Incidence of adverse events and serious adverse events during 24 weeks of TCZ monotherapy or combined treatment with TCZ and one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in patients with moderate to severe active RA | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed