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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02557308
Other study ID # CT-P13 4.4
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 2014
Est. completion date June 2026

Study information

Verified date July 2018
Source Celltrion
Contact HyeYoung Park
Phone +82-32-850-6562
Email HyeYoung.Park2@celltrion.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Description:

The primary objective of this study is to assess the safety of Remsima™ in ankylosing spondylitis (AS) patients, in comparison with patients receiving other anti-TNF drugs, by evaluation of events of special interest (ESI) for up to 5 years from the first visit of each patient.

In order to assess the primary study outcomes, the following ESI will be evaluated:

Identified risks:

- Hepatitis B virus reactivation

- Congestive heart failure

- Opportunistic infections (excluding tuberculosis)

- Serious infections including sepsis (excluding opportunistic infection and tuberculosis)

- Tuberculosis

- Serum sickness (delayed hypersensitivity reactions )

- Haematologic reactions

- Systemic lupus erythematosus/lupus-like syndrome

- Demyelinating disorders

- Lymphoma (not HSTCL)

- Hepatobiliary events

- Hepatosplenic T-cell Lymphoma (HSTCL)

- Serious infusion reaction during a re-induction following disease flare

- Sarcoidosis/sarcoid-like reactions

- Leukaemia

Potential risks:

- Malignancy (excluding lymphoma)

- Skin cancer

- Pregnancy exposure†

The secondary objectives of this study are to evaluate efficacy and additional safety of Remsima™ in AS patients, in comparison with patients receiving other TNF blockers.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date June 2026
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Adult patients

2. Patients with active AS

3. 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:

1. Patients with a history of hypersensitivity to infliximab

2. Patients with a current or past history of chronic infection

3. Patients with moderate or severe heart failure (NYHA class III/IV).

Study Design


Locations

Country Name City State
Korea, Republic of TaeHwan Kim Seoul

Sponsors (1)

Lead Sponsor Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of events of special interest in AS patients Patients will be observed for the events of special interest listed in protocol every visit, up to 5 years
Secondary Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) every 6 months, up to 5 years
Secondary Bath Ankylosing Spondylitis Functional Index (BASFI) every 6 months, up to 5 years
Secondary Visual Analogue Scale (VAS) or Numerical Rating Scale (NRS) Physician and Patient Global Assessment of Disease Status every 6 months, up to 5 years
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