Rheumatoid Arthritis. Rheumatoid arthritis with rheumatoid factor
Conditions
Interventions
Intervention 1: InterIntervention group 1 : The first group of rituximab drug with a dose of 1 gram will be injected intravenously (IV) at one time. Intervention 2: Intervention group 2: The second gr
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Having written informed consent to participate in the study Age 18 to 65 years• Weight less than 100 kg Definite diagnosis of rheumatism resistant to at least one of the anti-rheumatic drugs (DMARDS) and also having resistance to methotrexate Having moderate to severe rheumatoid arthritis with involvement of at least 4 painful joints and 4 swollen joints with ESR above 30 mm/h and CRP above 10 mg/l at the time of screening and entering the study If taking DMARDS drugs, stop them at least 2 weeks before entering the study The patient does not belong to functional class IV according to the ACR criteria. Has not had a history of rituximab injection within 2 years before entering the study During the 4 weeks before receiving tocilizumab, he has not received oral corticosteroids with a dose of more than 10 mg of prednisolone per day or other corticosteroids with an equivalent dose Do not have a history of increasing the number or dosage of DMARDS drugs or immunosuppressive drugs during the 4 weeks before starting treatment with tocilizumab.• He does not have a history of receiving live or weakened vaccine in less than 4 weeks before the start of the intervention.• Do not have a history of allergy to both mentioned drugs.• Has not had a history of performing plasmapheresis or major joint and cardiovascular surgeries during the 8 weeks prior to entering the study or did not intend to perform it during the 6 months of follow-up.• Do not have a history of other rheumatism and malignancy in the last 5 years. No history of treatment with ciclosporin and tacrolimus within 1 month before the intervention and no history of treatment with tocilizumab. The patient has normal GFR and liver enzymes Do not have a history of thrombocytopenia and AIDS, hepatitis B and C viral infections• Not taking drugs that interfere with rituximab or tocilizumab
Exclusion criteria
Exclusion criteria: Lack of consent to continue treatment in the study Death of the patient for any reason before the completion of the follow-up Undergoing joint surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rituximab, Tosilizumab. Timepoint: 6 month. Method of measurement: Patients activity, DAS28, PAP pain, ACR. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactElnaz Shafighi Shahri
Shahid Beheshti University of Medical Sciences
Outcome results
None listed