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Clinical Trials/KCT0009223
KCT0009223
Recruiting
未知

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

Chonnam National University Bitgoeul Hospital0 sites1,412 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Diseases of the musculoskeletal system and connective tissue
Sponsor
Chonnam National University Bitgoeul Hospital
Enrollment
1412
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational Study
Sex
All

Investigators

Sponsor
Chonnam National University Bitgoeul Hospital

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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