None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with: Ocrelizumab Placebo, IV, in a course of 2 doses separated by 14 days, on days 1 and 15 and in weeks 24, 52 and 76. Methotrexate will be administered concomitantly, in tablets, at a dose of 7.5 - 20 mg, PO, QD, for 104 weeks. After this period, patients can enter an open label extension period, where they can receive courses of 2 doses separated by 14 days of Ocrelizumab, at a dose of 500 mg, IV, at any time and according to criteria of the researcher, the duratio
This group will be treated with: Ocrelizumab, at a dose of 500 mg, IV, in a course of 2 doses separated by 14 days, on days 1 and 15 and in weeks 24, 52 and 76. Methotrexate will be administered at the same time. tablets, at a dose of 7.5 - 20 mg, PO, QD, for 104 weeks. After this period, patients can enter an open label extension period, where they can receive courses of 2 doses separated by 14 days of Ocrelizumab, at a dose of 500 mg, IV, at any time and according to criteria of the researcher
Sponsors
PRODUCTOS ROCHE Q.F.S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ability and willingness to grant written informed consent and comply with protocol requirements. 2. Age ≥ 18 years. 3. Have active disease. 4. Previous and current treatments: a) Patients without prior treatment and considered candidates for treatment with MTX. b) Patients who will receive treatment or current treatment for RA on an outpatient basis. c) If you are receiving current treatment with corticosteroids, the dose should not exceed 10 mg / day of prednisolone or equivalent and you should receive a stable dose during the four weeks prior to the baseline visit. d) If you are receiving current treatment with NSAIDs, the patient should be receiving a stable dose during the 4 weeks prior to the baseline visit. e) Patients should be willing to receive oral folic acid or equivalent. 5. Other: a) For patients of reproductive age, reliable methods of contraception should be used for the duration of the study according to local guidelines. b) Women patients of reproductive age must have a negative urine pregnancy test.
Exclusion criteria
Exclusion criteria: 1. Autoimmune rheumatic disease other than RA, or a significant systemic condition secondary to RA. 2. Functional class IV as defined by the Classification of the ACR of Functional State in AR. 3. History of, or current inflammatory joint disease other than RA or other systemic autoimmune disorders. 4. Any surgical procedure, including bone or surgery joint / synovectomy within the previous 12 weeks or planned within 48 weeks after the baseline visit. 5. Sepsis in an articular prosthesis within the last 48 weeks or indefinitely if the prosthesis remains in situ. 6. Lack of peripheral venous access. 7. Pregnancy or lactation. 8. Known significant cardiac disease (NYHA Class III and IV). 9. Known severe chronic obstructive pneumonia (COPD). 10. Evidence of significant uncontrolled concomitant diseases of the nervous system, renal, hepatic, endocrine, or gastrointestinal disorders. 11. Any neurological, psychiatric, vascular or systemic disorder that may affect any of the efficacy evaluations. 12. Uncontrolled diseases, where the exacerbations with corticosteroids are usually treated. 13. Primary or secondary immunodeficiency. 14. Known active infection of any type or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to the baseline visit or oral antibiotics within 2 weeks prior to the baseline visit. 15. History of tissue infection / deep spaces within 48 weeks of the baseline visit. 16. Evidence of chronic hepatitis B or C, active. 17. Evidence of active tuberculosis. 18. History of recurrent or severe chronic infections. 19. Cancer history within the last 10 years. 20. Currently active alcoholism or drug abuse; or a history of alcoholism or drug abuse within 24 weeks of the baseline visit. 21. History of severe allergic reaction or anaphylactic reaction to biological agents or known hypersensitivity to any component of the ocrelizumab infusion. 22. Pre-treatment of any biological therapy used for the treatment of RA. 23. Concomitant treatment with any DMARD. 24. Treatment with any agent under investigation 12 weeks or five half lives of the investigational drug. 25. Pre-treatment with any cell-depleting therapy, including products under investigation. 26. IV treatment with y-globulin or Prosorba® column within 24 weeks prior to the baseline visit. 27. Intraarticular or parenteral corticosteroids within 6 weeks prior to the baseline visit. 28. Receiver of any vaccine within 6 weeks prior to the baseline visit. 29. Intolerance or contraindications to methylprednisolone IV. 30. A positive urine pregnancy test. 31. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 2.5 times the upper limit of normal. 32. Hypogammaglobulinemia. 33. Absolute neutrophil count <1500 cells / uL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:X-ray evaluations will be done on hands and feet. Sharp s total modified score combines an erosion index and a joint space narrowing index of both hands and feet. The change in Sharp s total modified score is calculated as follows: TSS = TSS of Week 52 - Initial TSS TSS. Measure:Change from the initial in Sharp s total modified score. Timepoints:Week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criteria 1 and 7: The health assessment questionnaire - disability index (HAQ-DI), is an instrument of 20 questions that refer to eight components: dressing and grooming, getting up, eating, walking, hygiene, reaching things, grab and activities. Criterion 2: Application of DAS28 with a score of <2.6. Criteria 3 and 4: DAS28, is an instrument to assess the amount and degree of inflammation in 28 joints. Criterion 5: Response in the response rates of the European League against Rheumatism (EULAR), in those patients who respond categorically DAS28. Criterion 6: eliminate if an ACR20, ACR50, ACR70 and ACR90 have been achieved, which requires at least 20%, 50%, 70% or 90% improvement compared to the baseline in both TJCs and SJCs, as well as 20%, 50%, 70% or 90% improvement in three of the five additional measurements of: a) Overall assessment of the doctor s disease activity. b) Overall assessment of the patient s disease activity. c) Evaluation of the pain patient. d) Health assessment questionnaire - Disability index (HAQ-DI). e) An acute phase reactant - CRP or ESR. Measure:Criteria for the evaluation of signs and symptoms: 1) HAQ-DI score. 2) Proportion of patients with an important clinical response. 3) Proportion of patients achieving a remission score of Disease Activity (DAS28). 4) Change in DAS28 from the initial one. 5) EULAR response rates. 6) Proportion of patients that achieve an ACR20 / ACR50 / ACR70 / ACR90 response. 7) Proportion of patients with a reduction of at least 0.25 units in the HAQ-DI score from the initial. Timepoints:Criteria 1 and 7: Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, 52 and during follow-up. Criteria 2, 3, 4 and 5: Weeks 1, 4, 8, 12, 24, 32, 40, 52 and during follow-up. Criterion 6: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 26, 32, 40, 52, 54 and during follow-up. ; Outcome name:Criteria 1, 2, 3 and 5: These criteria will be evaluated on X-rays of the patients hands and feet. For this evaluat | — |
Countries
Austria, Estonia, Italy, Lithuania, Peru, United Kindgdom
Outcome results
None listed