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Anti-TNF-Study Utilizing Biomarker Assay to Monitor Early Response to Certolizumab Pegol

Anti-TNF-Study Utilizing Biomarker Assay to Monitor Early Response to Certolizumab Pegol - TSUBAME Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000022831
Enrollment
100
Registered
2016-08-02
Start date
2016-06-13
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

None listed

Sponsors

University of Occupational and Environmental Health, Japan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligible patients were diagnosed with RA, as defined by the ACR 1987 criteria or ACR/EULAR 2010 criteria.

Exclusion criteria

Exclusion criteria: Patients were excluded if they had history of demyelinating or convulsive disease of the central nervous system (e.g., multiple sclerosis and epilepsy), New York Heart Association Class III or IV congestive heart failure, infectious disease, hepatitis B or hepatitis C, malignant tumor or lymphoproliferative disorder, including lymphoma or signs and symptoms suggestive of lymphoproliferative disease. Patients with any indication of current or past tuberculosis as shown by clinical history, chest X-ray and/or positive tuberculin reaction test were also excluded unless preventive therapy by isoniazid was first taken.

Design outcomes

Primary

MeasureTime frame
Change of DAS28-ESR at 12weeks

Secondary

MeasureTime frame
(1) Change of DAS28-ESR at 24 hours, 48hours and 24weeks (2) Remission rate of DAS28 and CDAI at 24 hours, 48hours, 12 weeks and 24weeks (3) Adverse event (4) The factors for each outcomes

Countries

Japan

Contacts

Public ContactKazuhisa Nakano

University of Occupational and Environmental Health, Japan The First Department of Internal Medicine, School of Medicine

kazuhisa@med.uoeh-u.ac.jp093-603-1611

Outcome results

None listed

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