ISRCTN97443826已完成未知
A randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)
Queen Mary University of London (UK)0 个研究点目标入组 164 人开始时间: 2013年8月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 164
研究概览
简要总结
2021 results in https://pubmed.ncbi.nlm.nih.gov/33485455/ (added 25/01/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion criteria as of 13/01/2017:
- •1. Patients who have failed anti-TNF therapy (inadequate responders – ir). Note; this includes patients who have failed anti-TNF therapy because of reactions.
- •2. Who are eligible for Rituximab therapy according UK NICE guidelines*
- •3. Patients should be receiving a stable dose Methotrexate for at least 4 weeks prior to biopsy visit
- •4. 2010 ACR / EULAR Rheumatoid Arthritis classification criteria for a diagnosis of Rheumatoid Arthritis
- •5. 18 years of age or over
- •6. Patient must be capable of giving informed consent
- •7. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures
- •*Reference to NICE guidelines
- •1.1 Rituximab in combination with methotrexate is recommended as an option for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response to or intolerance of other disease-modifying anti-rheumatic drugs (DMARDs), including treatment with at least one tumour necrosis factor a (TNF-a) inhibitor therapy.
- •Original inclusion criteria:
- •Patients will be recruited with active RA:
- •1. Patients who have failed anti-TNF therapy (inadequate responders ir).
- •2. Who are eligible for Rituximab therapy according NICE guidelines
- •3. Patients should be receiving a stable dose Methotrexate for at least 4 weeks prior to screening.
- •4. 2010 ACR / EULAR Rheumatoid Arthritis classification criteria for a diagnosis of Rheumatoid Arthritis.
- •5. Over 18 years of age
- •6. Patient must be capable of giving informed consent
- •7. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures.
- •Target Gender: Male & Female ; Lower Age Limit 18 years
排除标准
- •Exclusion criteria as of 13/01/2017:
- •1. Women who are pregnant or breast-feeding
- •2. Women of child-bearing potential, or males whose partners are women of child-bearing potential, unwilling to use effective contraception during the study and for at least 12 months after stopping study treatment
- •3. History of or current primary inflammatory joint disease, or primary rheumatological autoimmune disease other than RA (if secondary to RA, then the patient is still eligible)
- •4. Prior exposure to Rituximab or Tocilizumab for the treatment of RA
- •5. Treatment with any investigational agent = 4 weeks prior to baseline (or < 5 half-lives of the investigational drug, whichever is the longer).
- •6. Intra articular or parenteral corticosteroids = 4 weeks prior to biopsy visit (Visit 2)
- •7. Oral prednisolone more than 10mg per day or equivalent = 4 weeks prior to biopsy visit (Visit 2)
- •8. Active infection
- •9. Septic arthritis within a native joint within the last 12 months
- •10. Sepsis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ.
- •11. Known HIV or active hepatitis B/C infection. Hepatitis B screening test must be performed at or in the preceding 3 months of screening visit.
- •12. Latent TB infection unless they have completed adequate antibiotic prophylaxis.
- •13. Malignancy (other than basal cell carcinoma) within the last 10 years
- •14. New York Heart Association (NYHA) grade 3 or 4 congestive cardiac failure.
- •15. Demyelinating disease
- •16. Latex allergy or allergy to any excipients of Rituximab or Tocilizumab
- •17. Any other contra-indication to the study medications as detailed in their summaries of product characteristics (SmPC), including low IgG levels at clinician’s discretion
- •18. Receipt of live vaccine <4 weeks prior to first infusion
- •19. Major surgery in 3 months prior to first infusion
- •20. Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening)
- •21. Known recent substance abuse (drug or alcohol)
- •22. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period
- •23. Patients unable to tolerate synovial biopsy or in whom this is contraindicated including patients on anti-coagulants (oral anti-platelet agents are permitted)
- •24. Patients currently recruited to other clinical trial(s) involving an investigational medicinal product (except any observational follow-up periods not involving an IMP)
- •25. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- •Original exclusion criteria:
- •1. Patients will be excluded if they have any contraindication to Rituximab or Tocilizumab therapy.
- •2. Women who are pregnant or breast-feeding
- •3. Women of child-bearing potential, or males w
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