Phase I/II study of subcutaneous injection of MRA

An open label, intra-patients dose ascending, repeated administration study of subcutaneous injection of MRA in patients with rheumatoid arthritis

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220688

Enrollment

Registered

2009-03-09

Start date

2009-03-09

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

investigational material(s) Generic name etc : MRA-SC INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with RA diagnosed according to the revised 1987 ACR. CRP or ESR at screening is >1mg/dL or >30 mm/h, respectively. Non responder or inadequate response patients who receive at least one DMARD or immunosuppressant.

Exclusion criteria

Exclusion criteria: Patients who are treated with biologics and/or leflunomide within 6 weeks before treatment. Patient's WBC, Neutrophil count and lymphocyte count are less than 3500, 1000 and 500/microL, respectively.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics/dynamics Relationship between serum concentration of MRA at trough level and CRP which is a biomarker of IL-6 inhibition.	—

Secondary

Measure	Time frame
Safety, torelability and effectiveness Adverse events, ACR20 and DAS28 score, Pain at injection site	—

Outcome results

None listed

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