Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.

JRCT ID: jRCTs071180018

Registered date:15/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 13/04/2018
• Target sample size: 44
• Study type: Interventional

Intervention(s)

Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6.
Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule.

Outcome(s)

Primary Outcome

Depth change from baseline of bone erosion by HR-pQCT measurement 6 months after starting administration.
Measurement part: second, third metacarpal bone

Secondary Outcome

1.Depth change from baseline of bone erosion by HR-pQCT measurement 12 months after starting administration.
Measurement part: second, third metacarpal bone
2.Depth change from baseline of bone erosion by HR-pQCT measurement.
Measurement part: wrist joint
3.Width and Volume change from baseline of bone erosion by HR-pQCT measurement.
Measurement part: second, third metacarpal bone and wrist joint

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who can be visited hospital diagnosed as rheumatoid arthritis by Rheumatoid arthritis classification criteria of ACR (revised in 1987) or ACR / EULAR (2010)
2) Patients with low or moderate disease activity
3) Patients under treatment with csDMARDs.
4) Patients with progressive bone erosion in image examination (either X-ray, MRI or ultrasound)
5) Patients who are 20 years older at the time of obtaining informed consent and can consent to the document to participate by my own will
6) Male and Female
7) Outpatient only

Exclude criteria

1) Patients complicated of osteoporosis who have not been treated for osteoporosis
2) Patients under treatment with intravenous bisphosphonate formulation and parathyroid hormone formulation
3) Patients under treatment with Denosumab
4) Patients under treatment with Biological disease-modifying anti-rheumatic drug and JAK inhibitor
5) Patients taking adrenal cortex hormone drug in excess of 10 mg / day in terms of prednisolone
6) Patients with a history of hypersensitivity to the components of Desnomab
7) Patients with hypocalcemia
8) Patients who are or may be pregnant
9) Patients currently participating in trials or studies of other medicines or medical devices
10) Patients who are breastfeeding or who want pregnancy during the study period
11) Patients who jugged unsuitable for this study by the investigator

Related Information

• Primary Sponsor: Kawakami Atsushi
• Source(s) of Monetary Support: Daiichi Sankyo co.,LTD.
• Secondary ID(s): UMIN000030575