Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting antibody

Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting antibody: A multicentre, open-label, prospective clinical trial with single treatment arm

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN82317088

Enrollment

Registered

2010-06-07

Start date

2010-08-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis Musculoskeletal Diseases Other rheumatoid arthritis

Interventions

This is a single treatment arm study involving 2 intravenous infusions of rituximab (1,000 mg/infusion) and methylprednisolone (100 mg/infusion), two weeks apart, as licensed for rheumatoid arthritis.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 or older 2. Established diagnosis of rheumatoid arthritis 3. Eligible for treatment with rituximab 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Concurrent bisphosphonate use 2. Poor previous compliance

Design outcomes

Primary

Measure	Time frame
Change in bone mineral density of spine, measured by Dual Energy X-Ray Absorptiometry (DEXA) at baseline and 12 months	—

Secondary

Measure	Time frame
1. Changes in bone mineral density of hips and forearms, measured by Dual Energy X-Ray Absorptiometry (DEXA) at baseline and 12 months 2. Changes in biochemical markers of bone turnover 3. Changes in biomarkers of inflammation and autoreactivity 4. Changes in disease activity 5. Number of new fractures 6. Duration of B cell depletion in blood All other outcomes (2-6) will be measured at baseline, 3, 6, 9, and 12 months using the following tools: Disease Activity Score for 28 Joints (DAS28), a validated and routine clinical assessment; Health Assessment Questionnaire (HAQ) a questionnaire-based investigation; Biomarkers are measured by a range of techniques incl flowcytometry, ELISA.	—

Measure

Time frame

1. Changes in bone mineral density of hips and forearms, measured by Dual Energy X-Ray Absorptiometry (DEXA) at baseline and 12 months 2. Changes in biochemical markers of bone turnover 3. Changes in biomarkers of inflammation and autoreactivity 4. Changes in disease activity 5. Number of new fractures 6. Duration of B cell depletion in blood All other outcomes (2-6) will be measured at baseline, 3, 6, 9, and 12 months using the following tools: Disease Activity Score for 28 Joints (DAS28), a validated and routine clinical assessment; Health Assessment Questionnaire (HAQ) a questionnaire-based investigation; Biomarkers are measured by a range of techniques incl flowcytometry, ELISA.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026