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.

Phase 1

• Conditions: rheumatoid arthritis; MedDRA version: 13Level: PTClassification code 10039073Term: rheumatoid arthritis

• Registration Number: EUCTR2010-020499-50-GB
• Lead Sponsor: South Tees Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-31
• Study Completion: 2012-12-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 46

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
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Use of bisphosphonates
2.Previous B-cell depleting therapy
3.Poor compliance of the patient as assessed by the referring physicians.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified