Analysis of effectiveness of Ozoralizumab toward bone structure in rheumatoid arthritis

JRCT ID: jRCTs071230067

Registered date:27/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 24/10/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): injection of ozoralizumab

Outcome(s)

• Primary Outcome: Volumetric change in bone erosions detected by HR-pQCT at 52 weeks in the ozoralizumab group and the historical control group per evaluated joint compared to baseline (screening period).

Secondary Outcome

1) Evaluate each parameter and other imaging studies (joint ultrasound, x-ray) for each evaluated joint detected by HR-pQCT
2) Disease activity

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)diagnosis of RA according to the American College of Rheumatology (ACR) RA Classification Criteria 1987 Revision or ACR/ European League Against Rheumatism (EULAR) 2010 RA Classification Criteria
2) age of 18 years or older
3) residual arthralgia during treatment with at least one csDMARD, including MTX
4) ability and willingness to provide written informed consent and comply with the requirements of the study protocol
5) Patients with a history of tuberculosis(TB) who have been confirmed free of active TB by a tuberculin reaction test or interferon gamma release assays in addition to a chest x-ray within the past year from the time of consent, or who are receiving appropriate antituberculosis drugs
6) Patients with moderate to high disease activity (DAS28-ESR>=3.2, DAS28-CRP>=2.7, SDAI>11, or CDAI>10) and joint destruction (joint space narrowing or bone erosion by either X-ray, MRI, or joint ultrasound)

Exclude criteria

1)Pregnant women or patients who may be pregnant.
2)the concurrent use of a corticosteroid equivalent to >10 mg/day of prednisolone
3) intra-articular injection of steroids into the joint being evaluated (2, 3 metacarpophalangeal(MCP) joints of both fingers and both wrist joints) within the last 6 months of obtaining consent
4)current use of denosumab, parathyroid hormone agonist and anti-sclerostin antibody
5)severe infection
6)active tuberculosis
7)Current and history of demyelinating disease
8)Current congestive heart failure
9)History of hypersensitivity to components of ozoralizumab
10)History of ozoralizumab use
11) Patients under treatment with biological agents and JAK inhibitors for RA, except for denosumab.
12)Patients with a history of tuberculosis who have not been confirmed to be free of active tuberculosis by a tuberculin reaction test or interferon gamma release assays in addition to a chest x-ray within the past year from the time of obtaining consent
13)Defects in the evaluated joints (2,3 MCP joints of both fingers and both wrist joints) or deformities due to previous surgical operations
14)inappropriateness for inclusion in this study as determined by the investigators.

Related Information

• Primary Sponsor: Kawakami Atsushi
• Secondary Sponsor: Taisho Pharmaceutical Co., Ltd.