Effects of Subcutaneous Actemura and MTX Blending in RA

Effects of Subcutaneous Actemura and MTX Blending in RA - eSCRAMBLE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012073

Enrollment

100

Registered

2013-10-21

Start date

2013-12-01

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

Adults with active RA (DAS28 &gt

3.2) despite methotrexate prescription were randomly assigned to continue methotrexate with the addition of tocilizumab (MTX+TCZ) 162mg/body every other week for 52 weeks. Adults with active RA (DAS28

3.2) despite methotrexate prescription were randomly assigned to switch to tocilizumab (TCZ) 162mg/body every other week for 52 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Those who had confirmed RA according to the ACR/EULAR criteria with active disease defined as disease activity score based on 28 joints-erythrocyte sedimentation rate (DAS28-ESR) greater than 3.2 at baseline. 2) Those who had been receiving methotrexate for at least 3 months 3) Those who had been receiving methotrexate for at least 3 months, with a stable dose. 4) Those who are able to comply with the study procedures and provide written informed consent

Exclusion criteria

Exclusion criteria: 1) Those whose joint damage was too severe to evaluate 2) Those who receiving tacrolims or tofacitinib 3) Those with allergy for tocilizumab 4) Those who had received treatment listed below within 4 weeks starting study treatment: Start taking prednisone or increasing dose of prednisone, leukocytapheresis, surgical procedures 5) lymphocyte count was below 1000/microL 6) Those who has suffered from infection disease 7) Those who was in pregnancy or possible pregnancy 8) Those that was judged to be inappropriate by the responsible physician

Design outcomes

Primary

Measure	Time frame
disease activity measurement in rheumatoid arthritis	—

Secondary

Measure	Time frame
radiological evaluation by modified total sharp score, evaluation of synovitis by ultrasound, measurements stratified by body weight	—

Countries

Japan

Contacts

Public ContactKentaro Inui

Graduate School of Medicine, Osaka City University Medical School Department of Orthopaedic Surgery

inuken@med.osaka-cu.ac.jp06-6645-3851

Outcome results

None listed

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