Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 60 of 299 for:    "Ankylosing spondylitis"

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.
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

Tracking Information
First Submitted Date May 15, 2015
First Posted Date September 23, 2015
Last Update Posted Date July 24, 2018
Study Start Date August 2014
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 21, 2015)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02557308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 21, 2015)
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: every 6 months, up to 5 years ]
  • Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis
Official Title An Observational, Prospective, Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis
Brief Summary An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with 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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples Without DNA
Description:
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.
Sampling Method Probability Sample
Study Population Approximately 1000 male or female patients with confirmed diagnosis of AS.
Condition Ankylosing Spondylitis
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 21, 2015)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2026
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: HyeYoung Park +82-32-850-6562 HyeYoung.Park2@celltrion.com
Contact: JooHee Lee +82-32-850-6565 JooHee.Lee@celltrion.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02557308
Other Study ID Numbers CT-P13 4.4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Celltrion
Study Sponsor Celltrion
Collaborators Not Provided
Investigators
Principal Investigator: Klara Sirova Revmatologie MUDr. Klara Sirova s.r.o. Chelčického 616/12 , 702 00, Czech Republic
PRS Account Celltrion
Verification Date July 2018