Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: RoActemra
Product Code: RO4877533
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Roche (Magyarország) Kft.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: 1. Able and willing to provide written informed consent and to comply with the requirements of the study protocol 2. Age = 18 years 3. Patients who complete their last WA19926 core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator’s assessment 4. No current or recent AE or laboratory finding preventing the use of TCZ 8 mg/kg at screening 5. Receiving treatment on an outpatient basis 6. For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use at least one adequate method of contraception, including at least one method with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: 1. Females who are pregnant 2. Patients who have prematurely withdrawn from the WA19926 core study for any reason 3. Treatment with any investigational agent or cell depleting therapies since the last administration of study drug in the WA19926 core study 4. Treatment with an anti-TNF or anti-IL1 agent, or a T-cell costimulation modulator since the last administration of study drug in the WA19926 core study 5. Immunization with a live/attenuated vaccine since the last administration of study drug in the WA19926 core study 6. Diagnosis since the last WA19926 visit (Week 104) of rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, and polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty’s syndrome). Secondary Sjögren’s syndrome and/or nodulosis with RA are permitted 7. Diagnosis since the last WA19926 core study visit (Week 104) of inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) 8. Laboratory parameters at baseline visit (4 to 12 weeks after the last administered dose of study drug in the WA19926 core study): a. AST or ALT = 1.5 times the upper limit of normal (ULN) b. Total Bilirubin > ULN c. Absolute neutrophil count < 1000/mm3 (1 x 10 9/L) d. Platelet count < 100 000/mm3 (100 x 10 9/L) 9. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies 10. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), immunologic or gastrointestinal disease; history of diverticulitis, diverticulosis requiring antibiotic treatment or chronic ulcerative lower gastrointestinal (GI) disease such as Crohn’s disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations for whom a favorable benefit/risk assessment for study continuation cannot be documented 11. Known active 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 chest X-ray [CXR] as determined by the Investigator, human immunodeficiency virus [HIV], hepatitis B [hepatitis B surface antigen {HBsAg} and total hepatitis B core antibody {HBcAb}] and hepatitis C virus [HCV] antibody (Ab) and Herpes zoster, but excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with IV antibiotics within four weeks prior to baseline or oral antibiotics within two weeks prior to baseline 12. Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (including hematological malignancies and solid tumors, except basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years 13. Uncontrolled disease states, such as asthma or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids 14. Current liver disease as determined by the Investigator 15. Active tuberculosis (TB) requiring treatment within the prev
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective for this study is as follows: • To evaluate the long term safety of TCZ therapy in patients who have completed the WA19926 core study and may benefit from TCZ treatment. ;Secondary Objective: The secondary objectives for this study are as follows: • To assess efficacy of TCZ over time using endpoints such as clinical remission based on Disease Activity Index 28 Erythrocyte sedimentation rate (DAS28-ESR) and/or Simplified Disease Activity Index (SDAI), and total tender joint count (TJC) and total swollen joint count (SJC). • To assess sustained drug free remission via DAS28-ESR and/or SDAI remission criteria. ;Primary end point(s): The long term safety outcome measures for this study are as follows: • Incidence and severity of adverse events (AEs), serious adverse events (SAEs), AEs of special interest. • Rates of AEs leading to dose modification or study withdrawal • Incidence of clinically significant laboratory abnormalities | — |
Countries
Hungary
Outcome results
None listed