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

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: NCT02557295
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 Rheumatoid Arthritis.

Condition or disease
Rheumatoid Arthritis

Detailed Description:

The primary objective of this study is to assess the long-term safety of Remsima™ in Rheumatoid Arthritis (RA) patients by evaluation of events of special interest (ESI) up to 5 years and to exploratory compare patients receiving Remsima™ with patients receiving non-biologic treatments or other anti-TNF drugs.

In order to assess the primary study outcomes, the following ESI will be evaluated:

  • Hepatitis B virus reactivation
  • Congestive heart failure
  • Opportunistic infection (excluding tuberculosis)
  • Serious infections including sepsis (excluding opportunistic infections and tuberculosis)
  • Tuberculosis (TB)
  • 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 reactions during a re-induction regimen following disease flare
  • Sarcoidosis/sarcoid-like reactions
  • Leukaemia
  • Malignancy (excluding lymphoma)
  • Skin cancer
  • Pregnancy exposure†
  • Infusion reaction associated with shortened infusion duration
  • Others

The secondary objectives of this study are to evaluate efficacy. Further, additional safety of Remsima™ in RA patients, in comparison with patients receiving non-biologic treatments or other anti-TNF drugs. Health-economics parameters will also be assessed.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 950 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 Rheumatoid Arthritis
Study Start Date : December 2013
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.
Biologic naive patients
Biologic naive patients (in Korea only)



Primary Outcome Measures :
  1. Detection of events of special interest in RA patients [ Time Frame: every visit, up to 5 years ]

Secondary Outcome Measures :
  1. Disease Activity Score 28 (DAS28) [ Time Frame: every 6 months, up to 5 years ]
  2. Health Assessment Questionnaire (HAQ) [ 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
The study population will consist of at least 950 male and female patients with Rheumatoid Arthritis
Criteria

Inclusion Criteria:

  1. Adult patients
  2. Patients with active RA
  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): NCT02557295


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
SungHawn Park Recruiting
Seoul, Korea, Republic of, 137-701
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: NCT02557295    
Other Study ID Numbers: CT-P13 4.2
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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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases