None listed
Conditions
Interventions
ONLY GRUPO Type of group
All patients in this study will receive Tocilizumab, in a dose of 8 mg / kg, IV, every 4 weeks for a maximum period of 7 years with 7 months or until they present unacceptable toxicity, decide to retire voluntarily or the researcher decides to remove them . Concomitantly, stable doses of methotrexate or other disease-modifying antirheumatics (DMARDs), corticosteroids in a dose ≤
10 mg / day of an equivalent to prednisone and NSAIDs, according to clinical evaluation may be used.
Sponsors
PRODUCTOS ROCHE Q.F.S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1) To have completed the treatment specified in the central studies and to receive the first scheduled infusion of tocilizumab (MRA) of the WA18696 between 4 and 12 weeks after the last IV infusion of the central studies. 2) Appointed and willing to give written informed consent and to comply with the requirements of the study protocol. 3) MTX or other DMARDs will be allowed if they are maintained in a dose and stable route of administration since the last study drug administration in the central studies. 4) Oral corticosteroids and NSAIDs are allowed if the dose is stable since the last administration of the central studies drug. 5) If patients are taking MTX, they should agree to receive oral folate. 6) Women with potential fertility and men with women couples with potential fertility can participate in this study only if they use a reliable contraceptive method. 7) If it is a woman with potential fertility, the patient must have a negative urine pregnancy test at the beginning.
Exclusion criteria
Exclusion criteria: 1) A treatment with any agent under investigation since the last administration of the central studies drug. 2) Previous treatment with any cell depletion therapy, including agents under investigation. 3) Treatment with intravenous gammaglobulin, plasmapheresis or Prosorba ™ column since the last administration of the central studies drug. 4) Treatment with an anti-TNF or anti-IL-1 agent, or a costimulation modulator of T cells or any biological or participate in any research study since the last administration of the central studies drug. 5) Intramuscular or intraarticular parenteral corticosteroids, in the six weeks prior to the start of WA18696. 6) Immunization with a live / attenuated vaccine since the last drug administration of the central studies. 7) Any previous treatment with alkylating agents. 8) History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. 9) Evidence of serious concomitant and uncontrolled cardiovascular, neurological, pulmonary, renal, hepatic, endocrine, immunological or gastrointestinal disease. 10) Bacterial, viral, fungal, mycobacterial or other known infections, active or with a history of recurrences, or any serious episode of infection that requires hospitalization or treatment with IV antibiotics within four weeks prior to initiation or oral antibiotics within two weeks before the initiation. 11) Evidence of active malignancy. 12) Patients whose AST or ALT values ​​≥ 3 times ULN, bilirubin> 2 times ULN or> 2.5 mg / dL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:1) Clinical evaluation of adverse events, where an adverse event is an unfavorable medical event in a patient who was administered a pharmaceutical product and who does not necessarily have to have a causal relationship with this treatment. Its severity (mild, moderate or severe) will be reported. 2) Laboratory tests: Hematology and serum chemistry panels, urinalysis. Measure:Safety of Tocilizumab: 1) Adverse events. 2) Laboratory abnormalities. Timepoints:1) Adverse events: Every 4 weeks until the end of the study. 2) Panels of hematology and serum chemistry: Every 2 weeks until week 12 and every 12 weeks until the end of the study. 3) Urinalysis: Every 4 weeks until week 8, in week 12 and every 12 weeks until the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Clinical evaluation to determine the number of patients that require concomitant treatment with corticosteroids, the number of patients who abandoned the treatment and the number of patients who change from monotherapy to combination treatment. 3) Use of the ACR (American College of Rheumatology) improvement criteria, classifying whether they achieved an improvement to 205 (ACR20), 50% (ACR50) and 70% (ACR70): The ACR evaluation involves the evaluation of 68 joints . 4) Application of the Result of Activity of the Disease modified for 28 joints (DAS28): Which is an index of activity of the AR that includes joint sensitivity, speed of erythrocyte sedimentation and general state of health. Measure:1) Percentage of patients with concomitant treatment with steroids. 2) Number of patients leaving the treatment. 3) Proportion of patients that reaches an ACR20, ACR50 or ACR70 response. 4) Proportion of patients that maintain a consecutive response ACR20, ACR50 or ACR70. 5) Individual components of the ACR response set. 6) Change of Disease Activity Result (DAS28) from the first dose of 8 mg / kg of tocilizumab (MRA). 7) Change of Disease Activity Result (DAS28) from the beginning of WA18696. 8) Proportion of patients who are DAS categorical responders. 9) Proportion of patients who remain as DAS categorical responders. 10) The proportion of patients who change from monotherapy to combination therapy. Timepoints:Weeks every 12 weeks until the end of the study, and clinical evaluation, also when required. ; Outcome name:1) Pharmacokinetics: Concentration before the dose of Tocilizumab MRA (before the dose). 2) Pharmacodynamics: Measurement of anti-MRA, IL-6 and slL-6R antibodies. Measure:Pharmacokinetics and Pharmacodynamics. Timepoints:Week 0 and every 48 weeks until the end of the study. ; Outcome name:1) Health Assessment Questionnaire, Disability Index (HAQ-DI): It is a questionnaire that evaluates functionality, | — |
Countries
Czech Republic, Denmark, Finland, Germany, Iceland, Italy, Peru, Portugal, Slovenia, Spain, Sweden, United Kindgdom
Contacts
Public ContactCarlos Battilana
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed