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) - R4-RA
- Conditions
- Rheumatoid ArthritisMedDRA version: 17.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2012-002535-28-IT
- Lead Sponsor
- Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 164
Patients will be recruited with active RA:
1. Patients who have failed anti-TNF therapy (inadequate responders – ir). Note: this includes patients that have failed anti-TNF therapy because of reactions.
2. Who are eligible for Rituximab therapy according NICE guidlines
3. Patients should be receiving a stable dose Methotrexate for at least 4 weeks prior to the biopsy visit.
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
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 whose partners are women of child-bearing potential, unwilling to use effective contraception during the study and for at least 6 months after stopping study treatment.
4.History of or current inflammatory joint disease or autoimmune disease other than RA
5.Treatment with any investigational agent = 4 weeks prior to baseline or < 5 half lives of the investigational drug
6.Intra articular or parenteral corticosteroids = 4 weeks prior to baseline
7.Active infection
8.Septic arthritis within a native joint within the last 12 months
9.Sepsis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ
10.Known HIV or hepatitis B/C infection
11.Latent TB infection unless they have completed adequate antibiotic prophylaxis
12.Malignancy (other than basal cell carcinoma) within the last 10 years
13.New York Heart Association (NYHA) grade 3 or 4 congestive cardiac failure
14.Demyelinating disease
15.Latex allergy or allergy to any excipients of Rituximab
16.Any other contra-indication to the study medications as detailed in their summaries of product characteristics
17.Receipt of live vaccine <4 weeks prior to first infusion
18.Surgery in 3 months prior to first infusion
19.Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening)
20.Known recent substance abuse (drug or alcohol)
21.Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period.
22.Patients unable to tolerate synovial biopsy or in whom this is contraindicated (e.g. patients on anti-coagulants such as warfarin or heparin).
23. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method