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Tapering and withdrawal of Methotrexate(MTX) or Tocilizumab(TCZ), after achievement of RA remission in concomitant use of MTX and TCZ,a randomized control study.

Tapering and withdrawal of Methotrexate(MTX) or Tocilizumab(TCZ), after achievement of RA remission in concomitant use of MTX and TCZ,a randomized control study. - Spacing tocilizumab vs tapering methotrexate study in Keio university, for rheumatoid arthritis patients In remission Phase.[SKIP] study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017577
Enrollment
60
Registered
2015-05-31
Start date
2015-06-01
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

continue treatment spacing and discontinue TCZ tapering and discontinue TCZ

Sponsors

Keio University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.RA patients who maintained remission(DAS28-ESR<2.6)for>=24weeks by administration of TCZ(8mg/kg)by interval of 4week and concomitant use of MTX(>=6mg/week)

Exclusion criteria

Exclusion criteria: 1.Patients who do not agree to participate in this study 2.Patient with any reasons for inadequate to participate in this study, judged by attending rheumatologist.

Design outcomes

Primary

MeasureTime frame
DAS28-ESR remission rate at 12week after discontinuing MTX or TCZ

Secondary

MeasureTime frame
1.discontinuation rate of TCZ 2.discontinuation rate of MTX 3.spacing interval of TCZ before RA flare 4.dose of MTX before RA flare 5.concentration of MTX-PG, extra/intra-cellular molecule at (1)initiation of tapering treatment (2)during tapering (3)after cessation of MTX or TCZ

Countries

Japan

Contacts

Public ContactShuntaro Saito

Keio University School of Medicine Division of Rheumatology, Department of Internal Medicine

shun081359@gmail.com03-3353-1211

Outcome results

None listed

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