An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

An Observational, Prospective, Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02557308
• Other study ID #: CT-P13 4.4
• Status: Recruiting
• 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
• 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).

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

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