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Trial record 1 of 2 for:    Remsima | Ankylosing Spondylitis
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An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT02557308
Recruitment Status : Recruiting
First Posted : September 23, 2015
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Celltrion

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

Condition or disease
Ankylosing Spondylitis

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: An Observational, Prospective, Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis
Study Start Date : August 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: every 6 months, up to 5 years ]
  2. Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: every 6 months, up to 5 years ]
  3. 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 ]

Biospecimen Retention:   Samples Without DNA
Blood samples for immunogenicity should be retained at the central laboratory up to the End of the Study, in case additional analysis is required. If additional analysis is not required during the study or after the End of the Study, blood samples will be stored in a CELLTRION, Inc. or designated biobank for a further 5 years (from the date the sample is transferred to the CELLTRION, Inc. or biobank) unless a specific authorization is given by CELLTRION, Inc.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Approximately 1000 male or female patients with confirmed diagnosis of AS.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557308


Contacts
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Contact: HyeYoung Park +82-32-850-6562 HyeYoung.Park2@celltrion.com
Contact: JooHee Lee +82-32-850-6565 JooHee.Lee@celltrion.com

Locations
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Korea, Republic of
TaeHwan Kim Recruiting
Seoul, Korea, Republic of, 133-792
Sponsors and Collaborators
Celltrion
Investigators
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Principal Investigator: Klara Sirova Revmatologie MUDr. Klara Sirova s.r.o. Chelčického 616/12 , 702 00, Czech Republic

Additional Information:

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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT02557308     History of Changes
Other Study ID Numbers: CT-P13 4.4
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis