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
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0009223
- Lead Sponsor
- Chonnam National University Bitgoeul Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1412
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)
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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug survival rate
- Secondary Outcome Measures
Name Time Method 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