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Efficacy and safety of certolizumab pegol in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor

Efficacy and safety of certolizumab pegol in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor - Efficacy and safety of certolizumab pegol in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000020154
Enrollment
150
Registered
2015-12-11
Start date
2016-01-06
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

Saitama Medical University, Department of Rheumatology and Applied Immunology
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. Patients had previous secondary inadequate response or were intolerant to a TNF antagonist other than certolizumab pegol.

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
Disease activity (DAS28, SDAI, CDAI), disability (HAQ-DI), Joint destruction (modified total Sharp score), adverse effects at week 0, 12, 24, 52.

Countries

Japan

Contacts

Public ContactFumie Iino

Saitama Medical University Hospital Clinical trial

f_yamamo@saitama-med.ac.jp049-276-2019

Outcome results

None listed

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