rheumatoid arthritis. Seropositive rheumatoid arthritis
Conditions
Interventions
Intervention 1: in interventional group:1-Altebrel 50mg/week (Equivalent to two 25mg / 0.5ml pre-filled syringes), which is administered 25 mg twice a week subcutaneously 2-oral methotrexate(MTX) 15m
treatment period=6months. Intervention 2: In control group:1-Enbrel 50mg/week (Equivalent to two 25mg / 0.5ml pre-filled syringes), which is administered 25 mg twice a week subcutaneously 2-oral meth
treatment period=6months.
Treatment - Drugs
in interventional group:1-Altebrel 50mg/week (Equivalent to two 25mg / 0.5ml pre-filled syringes), which is administered 25 mg twice a week subcutaneously 2-oral methotrexate(MTX) 15mg/week 3-Tablet
treatment period=6months
In control group:1-Enbrel 50mg/week (Equivalent to two 25mg / 0.5ml pre-filled syringes), which is administered 25 mg twice a week subcutaneously 2-oral methotrexate(MTX) 15mg/week 3-Tablet predniso
Sponsors
AryoGen Biopharma Company
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: inclusion criteria:1-Being male or female aged 18-75 years old,2-patients who have active Rheumatoid Arthritis have been diagnosed as having active RA according to the ACR criteria,3-patients who have not received Enbrel® yet, 4-Moderately to severely active RA for at least 6 months. 5-Patients who have inadequate response to the treatment with usual non-biological regimen for at least 12 weeks according to their investigator judgment, 6-Ability to comprehend and willingness to sign the Informed Consent Form for this study. exclusion criteria:1-ALT or AST levels greater than twice the upper limit of normal,2- Hemoglobin levels of less than 8.5 mg/dL,3-platelet count less than 125000 cells/mm3,4- leukocyte count less than 3500 cells/mm3 ,5- serum creatinine level more than 2mg/dL,6-Have a known hypersensitivity to human immunoglobulin proteins or other components of Enbrel or Altebrel, 7-Have been treated previously with any biological agents including any tumor necrosis factor inhibitor, 8-Have a history of acute myocardial infarction or unstable angina within the previous 12 months prior to Screening, 9-Concomitant therapy with DMARDs, 10-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, 11- Have a history of chronic or recurrent infection,12-Pregnancy, breastfeedin or planning for being pregnant,13-past history of heart failure or multiple sclerosis(MS),14-positive tests for HBSAg, HCVAb, HIVAb, PPD ,CXRay (TB ).
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in signs and symptoms of rheumatoid arthritis according to American college of rheumatology response criteria for 20%. Timepoint: Before beginning of treatment, after 3 months of treatment beginning, after 6 months of treatment beginning. Method of measurement: clinically,by the rheumatologist according to American college of rheumatology response criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in signs and symptoms of rheumatoid arthritis according to American college of rheumatology response criteria for 50%. Timepoint: Before beginning of treatment, after 3 months of treatment beginning, after 6 months of treatment beginning. Method of measurement: Clinically, by the rheumatologist according to American college of rheumatology response criteria.;Improvement in signs and symptoms of rheumatoid arthritis according to American college of rheumatology response criteria for 70%. Timepoint: Before beginning of treatment, after 3 months of treatment beginning, after 6 months of treatment beginning. Method of measurement: Clinically, by the rheumatologist according to American college of rheumatology response criteria.;Side effects. Timepoint: during treatment period (6 months); after 3 months of treatment beginning, after 6 months of treatment beginning. Method of measurement: Clinically, by the rheumatologist.;Concentration of the anti-drug antibodies. Timepoint: Prior to treatment and at months 3 and 6. Method of measurement: Validated Enzyme-Linked Immunosorbent Assay (ELISA). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Kamran Kamyar
AryoGen Biopharma Company
Outcome results
None listed