Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients capable of understanding and signing the informed consent and of respecting the procedures involved in the study 2. Patients with rheumatoid arthritis diagnosed for at least 3 months according to the 1987 criteria of the American College of Rheumatology (ACR) 3. Patients experiencing inadequate response to MTX at a dose of 12.5 25 mg/week (p.o. or parenteral) for at least 12 weeks, with the last 4 weeks prior to baseline maintained at a stable dose. A MTX dose of 7.5 or 10 mg/week is permitted only in case of documented intolerance to higher doses . 4. Disease duration 3.2 7. At screening: C reactive protein (CRP) > 0.6 mg/dL (6 mg/L) or ESR > 28 mm/h. 8. Age: 18-75 years. 9. Evidence of erosive disease and/or clinical synovitis in a signal (MRI) joint (metacarpophalangeal and/or wrist) 10. RA duration > 1 year: at least one erosion evaluated by a radiograph at the X-ray and evidence of clinical synovitis 11. RA duration =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria related to rheumatoid arthritis 1. Autoimmune rheumatic diseases other than RA. A past or present medical record reporting inflammatory joint diseases other than RA (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or any other systemic autoimmune disease (e.g. SLE, inflammatory intestinal disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or any other concomitant syndrome).General exclusion criteria 2. Surgical operations (including synovectomy) on bones/joints (including fusion or joint replacements) in the 12 weeks prior to the baseline visit or, in the case of scheduled surgery, within 48 weeks of randomization. 3. Absence of peripheral venous access. 4. Women who are pregnant or breast-feeding. 5. Significant heart disease (NYHA class III - IV) or lung disease, the latter unrelated to the pathology (including obstructive lung disease). 6. Evidence of a serious concomitant and uncontrolled disease concerning the nervous system, kidney, liver, endocrine glands or gastrointestinal tract, which, in the doctor's opinion, would preclude the participation of the patient. 7. Primary or secondary immunodeficiency (previous or currently active), including a history of HIV infection. 8. Active infections of any kind (excluding mycotic infections of the nail bed), or any important episode requiring hospitalisation or intravenous therapy with anti-infective agents in the 4 weeks prior to baseline or oral anti-infective agents in the 2 weeks prior to baseline. 9. A history of deep tissue infections (e.g. fasciitis, abscesses, osteomyelitis) within 52 weeks of selection. 10. A history of serious recurrent or chronic infections (to verify the presence of chest infections a chest x-ray will be performed at screening, if not already performed in the 12 weeks prior to screening). 11. Uncontrolled high or low blood pressure. 12. A history of neoplasia, including solid tumours, haematological neoplasia and carcinoma in situ in the previous 10 years (except for basal cell and squamous cell skin cancer already removed and healed). 13. Neurological disorders (congenital or acquired), vascular or systemic diseases that could interfere with the evaluation of efficacy, particularly with joint pain and swelling (e.g. Parkinson's disease, cerebral palsy, diabetic neuropathy). 14. Alcohol or drug abuse or a history of alcoholism or drugaddiction in the 24 weeks prior to baseline. Exclusion criteria related to MRI 15. Impossibility to perform MRI due to known allergy to Gadoteridol or presence of metallic implants in the area to be examined. Exclusion criteria related to therapy 16. Confirmed hypersensitivity to any component of Rituximab or to murine proteins. 17. Concomitant treatment with biological agents. 18. Previous treatment with more than one biological agent approved for RA. 19. Previous treatment with cell-depleting therapies, including experimental agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, anti-CD11a, anti-CD22, anti-BLys/ BAFF, and anti-CD20). 20. Previous treatment with any experimental agent within 28 days of baseline or within a period equal to five times the half-life of the experimental drug (whichever time is longest). 21. Administration of any vaccine within 28 days prior to baseline (it is recommended that a patient's vaccination record and the need for immunization prior to receiving
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate modifications of the synovial membrane enhancement, the extent of bone marrow oedema, and the number and extent of erosions in the wrist and metacarpophlangeal joints of RA patients after a single course (two infusions 15 days apart) of Rituximab. MRI will be performed on a low field extremity-dedicated system (Artoscan, ESAOTE) using the RAMRIS scoring system developed by OMERACT and dynamic gadolinium-enhanced MRI of the wrist, a new MRI technique devised to evaluate inflammatory synovial neoangiogenesis.;Secondary Objective: not planned;Primary end point(s): The primary endpoint of the study is to test whether low field MRI can detect Rituximab-induced changes of synovitis and bone damage in a small group of RA patients within 6 months from the infusion. These changes will be compared with those observed in a cohort of patients from another study who underwent high field MRI evaluation. | — |
Countries
Italy
Outcome results
None listed