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

July 23, 2018 updated by: Celltrion

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

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

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Approximately 1000 male or female patients with confirmed diagnosis of AS.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Remsima™
Patients who are taking Remsima™ for the treatment
Other anti-TNF drugs
Patients who are taking other anti-TNF drugs such as infliximab (Remicade®), etanercept, adalimumab, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of events of special interest in AS patients
Time Frame: every visit, up to 5 years
Patients will be observed for the events of special interest listed in protocol
every visit, up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: every 6 months, up to 5 years
every 6 months, up to 5 years
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: every 6 months, up to 5 years
every 6 months, up to 5 years
Visual Analogue Scale (VAS) or Numerical Rating Scale (NRS) Physician and Patient Global Assessment of Disease Status
Time Frame: every 6 months, up to 5 years
every 6 months, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celltrion

Investigators

  • Principal Investigator: Klara Sirova, Revmatologie MUDr. Klara Sirova s.r.o. Chelčického 616/12 , 702 00, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

May 15, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 23, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-P13 4.4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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