None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Tocilizumab 8 mg / kg IV every 4 weeks for 24 weeks. They will also receive Methotrexate Placebo once a week until 24 weeks
Group name:GROUP 3 Type of group
This group will be treated with Tocilizumab Placebo IV every 4 weeks for 24 weeks. In addition they will receive Methotrexate Placebo once a week for 24 weeks.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Inclusion criteria
Inclusion criteria: 1140/5000 1. Able and willing to give written, free and informed consent and comply with the requirements of the study protocol. 2. Patients with Rheumatoid Arthritis diagnosed of> 3 months duration. 3. Receiving treatment as an outpatient. 4. Prior to randomization, etamecept should be discontinued for> 2 weeks, infliximab or adalimumab for> 8 weeks, anakinra for> 1 week, leflunomide for> 12 weeks. 5. All DMARDs withdrawn before the baseline. 6. Inflamed joint count (SJC)> 6 and painful joint count (TJC)> 8. 7. During PCR selection> 1 mg / dL (10 mg / L) or ESR> 28 mm / h. 8. Age> 18 years. 9. Oral corticosteroids and NSAIDs are allowed if the dose has been stable for at least 6 weeks before. 10. Women with gestational capacity and men with female partners with gestational ability can participate in this trial only if they are using a reliable means of contraception. 11. If she is a woman and capable of gestation, the patient must have a pregnancy test in negative urine within three weeks before the baseline.
Exclusion criteria
Exclusion criteria: 1. Major surgery within prior eight weeks. 2. Rheumatic autoimmune disease apart from AR. 3. Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis. 4. Previous or current history of joint inflammatory disease apart from RA. 5. Treatment with MTX within 6 months prior. 6. Previous discontinued MTX treatment as a result of clinically significant toxic effects or lack of response. 7. Unsuccessful treatment with an anti-TNF agent. 8. Treatment with any research agent within four weeks of the selection. 9. Previous treatment with any cell depletion therapy. 10. Treatment with intravenous globulin, plasmapheresis or Prosorba ™ column within six months of the baseline. 11. Intra-articular or parenteral corticosteroids within six weeks before the baseline. 12. Immunization with live / attenuated virus vaccines within four weeks before the baseline. 13. Previous treatment with MRA. 14. Any previous treatment with alkylating agents. 15. History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies. 16. Evidence of cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal concomitant 17. States of uncontrolled disease. 18. Current liver disease. 19. Currently active or recurrent historical infections. 20. Primary or secondary immunodeficiency. 21. History of malignancy, including solid tumors and hematologic malignancies. 22. Pregnant women or nursing mothers. 23. History of alcohol, drug or chemical abuse within six months before the selection. 24. Neuropathies or other painful conditions. 25. Patients with lack of peripheral venous access. 26. Body weight of> 150 Kg. 27. Serum creatinine> 1.4 mg / dL in female patients and> 1.6 mg / dL in male patients. 28. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 1.5 times the upper limit of normal (ULN). 29. Platelet count ULN. 37. Triglycerides> 10 nunol / L (> 900 mg / dL).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: Improvement in at least 20% in the counting of painful and inflamed joints. Measure:Primary efficacy: Proportion of patients with an ACR20 response. Timepoints:Week 24. ; Outcome name:Panel of hematology and serum biochemistry. Lipid panel. Urinalysis Hemolysis profile. Liver Function Profile. Measure:Alterations in laboratory tests. Timepoints:Panel of hematology and serum biochemistry: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32. Lipid panel: Weeks 0, 6, 14, 24, 28, 32. Urinalysis: Weeks 0, 4, 8, 16, 24, 28, 32. Hemolysis profile: Weeks 0, 24, 28, 32. Hepatic Function Profile: Week 0. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: Count of painful and inflamed joints. Laboratory tests: FR, VSG, PCR. Scales: HAQ, SF-36 and FACIT. VAS scale of pain. Measure:Secondary Efficacy: Proportion of patients with an ACR20 response in week 8. Proportion of patients with ACR50 and ACR70 responses in 24 weeks. Change in the Disease Activity Score (DAS). Proportion of patients classified as responders of Categorical DAS (EULAR response). Proportion of patients with a DAS score <1.6. Fatigue scale scores of HAQ, SF-36 and FACIT. Proportion of patients who withdraw. Proportion of patients in each treatment group receiving rescue therapy. Average change in rheumatoid factor. Median time of improvement in VAS of daily pain. Change from baseline to hemoglobin. Timepoints:Joint count: Weeks 0, 2, 4, 8, 12, 16, 20 and 24. PCR and VSG: Weeks 0, 2, 4, 6, 8, 12, 14, 16, 20 and 24. HAQ: Weeks 0, 2, 4, 8, 12, 16, 20, 24. SF-36: Weeks 0, 8, 16 and 24. FACIT: Weeks 0, 4, 8, 12, 26, 20, 24. VAS: Weeks 0, 2, 4, 6, 8, 12, 16, 20 and 24. ; Outcome name:Report of adverse events. Chest x-ray. ECG. Physical examination and vital signs. Measure:Safety of the treatment: A Timepoints:Report of adverse events: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32. Chest x-ray: Week 0. ECG: Before the start of the trial and in week 24. Physical examination and vital signs: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32. ; Outcome name:Panel of hematology and serum biochemistry. Lipid panel. Urinalysis Hemolysis profile. Liver Function Profile. Measure:Alterations in laboratory tests. Timepoints:Panel of hematology and serum biochemistry: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32. Lipid panel: Weeks 0, 6, 14, 24, 28, 32. Urinalysis: Weeks 0, 4, 8, 16, 24, 28, 32. Hemolysis profile: Weeks 0, 24, 28, 32. Hepatic Function Profile: Week 0. | — |
Countries
Argentina, Australia, Canada, China, Croatia, Denmark, France, Israel, Italy, Lithuania, Mexico, Norway, Portugal, Serbia, Slovenia, South Africa, Spain, United States
Contacts
Public ContactArmando Luza
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed