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An observational, prospective cohort study to evaluate the long-term safety and efficacy of infliximab SC in patients with Ankylosing spondylitis, Rheumatoid arthritis in Korea

An observational, prospective cohort study to evaluate the long-term safety and efficacy of infliximab SC in patients with Ankylosing spondylitis, Rheumatoid arthritis in Korea

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009223
Enrollment
1412
Registered
2024-03-07
Start date
2021-11-15
Completion date
Unknown
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Chonnam National University Bitgoeul Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who can administer Infliximab SC (subcutaneous injection) under approved indication of this drug 2) an adult patient over the age of 19 3) Those who voluntarily agreed in writing to this study 4) Among women of childbearing age, appropriate contraception is performed to prevent pregnancy and Infliximab SC 5) Those who can use contraception for at least six months after the final dose (the implementation of contraception is based on risks and benefits) It can be decided after discussion with a female researcher.) 5) Voluntarily for long-term follow-up, including access to all medical records Patient by (signed ICF)

Exclusion criteria

Exclusion criteria: 1) A person who is prohibited from being administered as specified in the product description of this drug 2) A person who intends to use Infliximab SC for purposes other than permission 3) a pregnant woman or nursing woman 4) Patients who are unfit to participate in research by researcher's judgment

Design outcomes

Primary

MeasureTime frame
Drug survival rate

Secondary

MeasureTime frame
EQ-5D-5L;Work productivity and activity impairment questionnaire(WPAI);Adverse event of special interest, AESI;trough level;Anti-drug antibody(ADA);Drug survival;Primary response rate;Sustainable Clinical response rate;Ankylosing Spondylitis Disease Activity Score(ASDAS) ;Visual Analog Scale;ASAS-HI

Countries

Korea, Republic of

Contacts

Public ContactShinseok Lee

Chonnam National University Hospital

ss0413_33@naver.com+82-62-220-6590

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026