EUCTR2010-020499-50-GB
Active, not recruiting
Phase 1
Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody.An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial. - Effects of B cell depletion on bone turnover in rheumatoid arthritis.
DrugsMabThera
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- South Tees Hospitals NHS Foundation Trust
- Enrollment
- 46
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Mimimum age 18 years.
- •2\.Diagnosis of rheumatoid arthritis according to ACR classification criteria.
- •3\.Eligibility for treatment with rituximab according to NICE\-guidelines
- •4\.First treatment course of rituximab within 6 weeks after screening
- •5\.Written informed consent
- •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
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •1\.Use of bisphosphonates
- •2\.Previous B\-cell depleting therapy
- •3\.Poor compliance of the patient as assessed by the referring physicians.
Outcomes
Primary Outcomes
Not specified
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