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
Not Applicable
- Conditions
- rheumatoid arthritis
- Registration Number
- JPRN-UMIN000013614
- Lead Sponsor
- Katayama Orthopedic Rheumatology Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1) Severe infections. 2) Desire pregnancy or during pregnancy. 3) Inadequate to enter this trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.