Clinical trial NCT02557308: An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis
Official title: An Observational, Prospective, Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ankylosing Spondylitis
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2015-09-23
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 1000 male or female patients with confirmed diagnosis of AS.

Brief summary: An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis

Detailed description: This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with AS in comparison with patients receiving other TNF blockers. For the RemsimaTM cohort data will be collected for patients who commence treatment with RemsimaTM in accordance with the product label at the time of enrolment. Patients who have been treated with Remicade® prior to enrolment, their dosing schedule will be continued appropriately. This observational study allows drug switching between anti-TNF drugs. If switched to RemsimaTM, data will be collected until the end of study for each patient. If switched to other anti-TNF drugs (infliximab (Remicade®), etanercept, adalimumab and etc.), data will be collected until 1 year from the day of switch or until the end of study for each patient, whichever reaches earlier. For switched patients, their assessment schedule will be re-started from the day of switch. Patients will undergo safety and efficacy assessments in accordance with routine medical practice. The decision to treat with RemsimaTM will be independent of the decision to enroll the patient in this registry.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Patients with active AS
* Patients who meet the following conditions can be enrolled:

  i) The RemsimaTM cohort will include all patients who will start RemsimaTM at the time of enrolment in accordance to the approved product label ii) Patients who have started to be treated with an established anti -TNF such as Infliximab (Remicade®), Etanercept, Adalimumab and etc. within 6 months
* Female patients of childbearing potential who agree to use of adequate contraception to prevent pregnancy and continuation of contraceptive use for at least 6 months after their final dose of RemsimaTM.
* Patients (or legal guardian, if applicable) who are willing to give informed consent for long term follow-up including access to all medical records

Exclusion Criteria:

* Patients with a history of hypersensitivity to infliximab
* Patients with a current or past history of chronic infection
* Current diagnosis of TB or severe or chronic infections (e.g. sepsis, abscess or opportunistic infections or invasive fungal infections), or a past diagnosis of TB or severe or chronic infection, without sufficient documentation of complete resolution following treatment.
* Recent exposure to persons with active TB, or a positive test result for latent TB (defined as a positive interferon-γ release assay \[IGRA\] with a negative examination of chest X-ray) at Screening.
* Patients with moderate or severe heart failure (NYHA class III/IV).

Primary outcomes:
measure: The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
timeFrame: Duration of study participation (up to 5 years)
Secondary outcomes:
measure: The Number and Percentage of Patients Achieving BASDAI 50
timeFrame: Month 6 ~ Month 48 (every 6 months ± 6 weeks)
measure: Descriptive Statistics for BASFI
timeFrame: Day 0 ~ Month 48 (every 6 months ± 6 weeks)
measure: Descriptive Statistics of Physician Global Assessment Score
timeFrame: Day 0 ~ Month 48 (every 6 months ±6 weeks)
measure: Descriptive Statistics of Patient Global Assessment Score
timeFrame: Day 0 ~ Month 48 (every 6 months ±6 weeks)
measure: Descriptive Statistics of Spinal Pain Score
timeFrame: Day 0 ~ Month 48 (every 6 months ±6 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Revmatologie MUDr. Klara Sirova s.r.o. Chelčického 616/12 , 702 00, Czech Republic
name: Klara Sirova
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheon JH, Nah S, Kang HW, Lim YJ, Lee SH, Lee SJ, Kim SH, Jung NH, Park JE, Lee YJ, Jeon DB, Lee YM, Kim JM, Park SH. Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness. Adv Ther. 2021 Aug;38(8):4366-4387. doi: 10.1007/s12325-021-01834-3. Epub 2021 Jul 12.