Rheumatoid Arthritis. Other seropositive rheumatoid arthritis ,Seronegative rheumatoid arthritis
Conditions
Interventions
Intervention 1: Temziva (produced by AryoGen Pharmed) prefilled syringe for patients with dose of 162 mg, subcutaneous (S/C) injection every other week during 24 weeks of study. Intervention 2: Actemr
Sponsors
AryoGen Pharmed Co.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Male or female aged 18 –65 years at the time of signing the informed consent form Participants who have been diagnosed as having rheumatoid arthritis for at least 6 months, using the 2010 American College of Rheumatology/European League Against Rheumatism (2010 ACR/EULAR) classi?cation criteria for RA. Patients who have an inadequate response of at least 12 weeks to = 1 conventional disease-modifying antirheumatic drugs (DMARDs) in which 1 of them is definitely methotrexate, according to their investigator judgment. Moderate to severe rheumatoid arthritis with =4 tender joints (of 68 joints); =4 swollen joints (of 66 joints); and an erythrocyte sedimentation rate (ESR) =30 mm/hour or a C-reactive protein level (CRP) =1.0 mg/dl at screening Patients discontinued all biological DMARD, including etanercept for 2 weeks or longer and in?iximab, certolizumab, golimumab or adalimumab for 8 weeks or longer because of side effects, lack of compliance or lack of response. Ability to comprehend and willingness to sign the Informed Consent Form for this study
Exclusion criteria
Exclusion criteria: Active tuberculosis or Patients testing positive for latent tuberculosis (PPD > abnormal CXR) Have a history of serious allergies or a known hypersensitivity to Tocilizumab or any components of the formulations. Have an active hepatitis B or C or positive hepatitis B surface antigen or hepatitis C antibody. Have a known history of infection with human immunodeficiency virus (HIV). Patients who are weighing = 100 kg Patients who had thrombocytopenia (platelet count 10 mg/day of prednisolone or equivalent; or had a dose increase, new administration, or intravenous, intraarticular or intramuscular injections of glucocorticoids within 4 weeks of Tocilizumab treatment. Patients who had dose changes or added-in DMARDs or immunosuppressants within 4 weeks of Tocilizumab treatment. Immunization with a live/attenuated vaccine less than 4 weeks before baseline or planning to receive a live vaccine during the study. Women who are pregnant, breastfeeding or planning to become pregnant during the study. Patients who have stopped previous MTX treatment due to hepatotoxicity. Patients with an active infection or who have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to screening. Having history of any malignancy within the previous 5 years prior to Screening. Having rheumatic disease or inflammatory joint disease other than rheumatoid arthritis Having history of demyelinating disorders including multiple sclerosis. Patients with a certain history of gastrointestinal disorders such as diverticulitis, active peptic ulcer or active duodenal ulcer which have been approved by a gastroenterologist. Patients who had GFR< 60 ml/min/1.73 m2 Patients with a history of treatment with cyclosporine or tacrolimus within 1 month of receiving tocilizumab. Having any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled. Patients who had previously received JAK inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The patients response. Timepoint: Prior to, and 24 weeks after first intervention. Method of measurement: ACR 20 response criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| The patients response. Timepoint: Prior to intervention and 12 weeks after the first intervention. Method of measurement: ACR20 response criteria.;The patients response. Timepoint: 12 and 24 weeks after the first intervention. Method of measurement: ACR50 and ACR70 response criteria.;Change in patients disability. Timepoint: Prior to intervention, 12 and 24 weeks after the first intervention. Method of measurement: HAQ Questionnaire.;Change in Disease Activity. Timepoint: 12 and 24 weeks after the first intervention. Method of measurement: DAS-28 index.;Percentage of the patients at remission. Timepoint: 12 and 24 weeks after the first intervention. Method of measurement: DAS-28 index score below 2.6.;Adverse events (AEs), Adverse drug reactions (ADR). Timepoint: at screening visit and at each visit including day 0 and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24 after the first injection. Method of measurement: Medical examination.;Changes in physical examination findings. Timepoint: at screening visit, and 12 and 24 weeks after the first intervention. Method of measurement: Medical examination.;Changes in vital signs (blood pressure). Timepoint: at screening visit and prior to intervention, and weeks 12 and 24 after the first intervention. Method of measurement: Medical examination.;Immunogenicity of the drug. Timepoint: Prior to intervention, and 12 and 24 weeks after the first intervention. Method of measurement: laboratory tests. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Nassim Anjidani
OrchidPahrmed Co
Outcome results
None listed