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Trial record 1 of 4 for:    Remsima | Ankylosing Spondylitis
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An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02557308
Recruitment Status : Recruiting
First Posted : September 23, 2015
Last Update Posted : July 24, 2018
Information provided by (Responsible Party):

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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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 identifier (NCT number): NCT02557308

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Contact: HyeYoung Park +82-32-850-6562
Contact: JooHee Lee +82-32-850-6565

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Celltrion Identifier: NCT02557308    
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, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases