Tocilizumab and rituximab in rheumatoid arthritis

Phase 2

• Conditions: Rheumatoid Arthritis.; Rheumatoid arthritis with rheumatoid factor

• Registration Number: IRCT20230923059495N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 22

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rituximab, Tosilizumab. Timepoint: 6 month. Method of measurement: Patients activity, DAS28, PAP pain, ACR.