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Inhibitory effects on bone marrow edema and rapid radiographic progression by short term uage of biologics with early rheumatoid arthritis patients inadequate response to non biological disease modifying antirheumatic drugs with extensive bone marrow edema in hand magnetc resonance imaging

Inhibitory effects on bone marrow edema and rapid radiographic progression by short term uage of biologics with early rheumatoid arthritis patients inadequate response to non biological disease modifying antirheumatic drugs with extensive bone marrow edema in hand magnetc resonance imaging - Inhibitory effects on hand MRI bone marrow edema and rapid radiographiic progrssion by short term usage of biologics in early RA patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013614
Enrollment
80
Registered
2014-06-13
Start date
2014-06-13
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

rheumatoid arthritis

Interventions

In patients whose bone marrow edema score of hand MRI 24 weeks after biologic therapy improve &gt
70 % compared with baseline bone marrow edema score, biologics are step down and step out over the 52 weeks. (Arm A) In patients whose bone marrow edema score of hand MRI 24 weeks after biologic ther
70 % compared with baseline bone marrow edema score, biologics are continued over the 52 weeks. (Arm B) In patients whose bone marrow edema score of hand MRI 24 weeks after DMARDs dose up or combi
70% compared with baseline bone marrow edema score, the DMARDs enhancement therapies are contined over the 52 weeks. (Arm C)

Sponsors

Katayama Orthopedic Rheumatology Clinic
Lead Sponsor
1)Departmentof Orthopedic Surgery, Asahikawa Medical University 2)Chondrex Inc 3)Asama Chemicals Co. Ltd
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Satisfied 2010ACR/EULAR criteria 2) Disease duration ≤ 3 years. 3) No use of biologics 4) Use DMARDs including methotrexate. 5) DAS28-ESR ≥ 3.2 6)Predonin dose ≤7.5mg/day 7) Extensive bone marrow edema in hand MRI (RAMRIS bone marrow score ≥15)

Exclusion criteria

Exclusion criteria: 1) Severe infections. 2) Desire pregnancy or during pregnancy. 3) Inadequate to enter this trial.

Design outcomes

Primary

MeasureTime frame
1) At24 weeks, all of patients treated with BIO+DMARDs or DMARD enhancement(dose up,combination) are investigated for relationship beteen MRI BE and the inhibition of radiographic joint damageand and RRP. 2)Next 24,52 weeks, all of patients satisfing good improvent of extensive BE are investigated for the inhibition of MRI BE,radiographic joint damage and RRP between BIO free or reduction(+DMARDs)group and BIO+DMARDs continuation group,DMARDs enhancement continuation group. 3)Continuation rate of BIO free or reduction(+DMARDs)group in next24,52 weeks.—

Secondary

MeasureTime frame
1)At 24 weeks after treatment, all of patients treated with BIO+DMARDs or DMARD enhancement(dose up,combination) are investigated for a) Percentage of DAS28 LDA,remission achievment b)Percentage of functional remission (HAQ-DI) c) Ultra sound PD, GS score in hand d)Changes of serum factors(cytokines etc) 2))Next 24,52 weeks, all of patients satisfing good improvent of extensive BE are investigated for above a)b)c)d)items.—

Countries

Japan

Contacts

Public ContactKou Katayama

Katayama Orthopedic Rheumatology Clinic Rheumatology

kou@kata-rheum.or.jp0166-39-1155

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026