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Efficacy and security of certolizumab pegol treatment in patients with reumatoid arthritis

Efficacy and security of certolizumab pegol treatment in patients with reumatoid arthritis - Saitama East Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014486
Enrollment
100
Registered
2014-12-01
Start date
2015-06-21
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

RA patients with medium disease activity are treated with 200mg of CZP (loading dose method is ommited)

Sponsors

Saitama East Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients are fulfilled ACR(1987) or ACR/EULAR classification criteria for rheumatoid arthritis and are diagnosed as RA. 2.Patients have never treated with any biologics. 3.Before CPZ treatment,the dose and method of DMARD have not changed at leaset 8 weeks. 4.Before CPZ treatment,the dose and method of NSAIDs have not changed at leaset 4 weeks. 5.Before CPZ treatment,the dose and method of glucocorticoid have not changed at leaset 4 weeks.Patiennts are treated with prednisolone of 10mg/day or thess than 10mg/day. 6.The patients have swollen joints of 6 or less than 6 joints and have tender joints of 6 or less than 6 joints.

Exclusion criteria

Exclusion criteria: 1.Patients have other rheumatic diseases. 2. Patients have malignant disorders in recent 5 years. 3.Patients have a risk for tuberculosis. 4.Patients who develpoprd bacterial infection and antibiotics were administrated within 30 days after first CPZ treatment. 5.Drug or alcohol addiction or abusers. 6.Patients who are not able to be adequately evaluated in this study. 7.Patients who have Type B viral hepatitis. 8.Patients who have nontuberculous mycobacteril infection. 9.Patients who have congestive heart failure(>II).

Design outcomes

Primary

MeasureTime frame
Number(%) of patients who developed in low disease activity from 12 to 52 weeks

Countries

Japan

Contacts

Public ContactShigeto Kobayashi

Juntendo University, Juntendo Koshigaya Hopspital Rheumatology, Internal Medicine

shigeto@juntendo.ac.jp048-975-0321

Outcome results

None listed

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