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Observational Study of Golimumab Intravenous Infusion

NCT ID: NCT02390700

Last Updated: 2016-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-10-31

Brief Summary

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The purpose of this study is to evaluate the incidence and management of infusion reactions with Golimumab intravenous infusion.

Detailed Description

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This is a prospective, observational, non-interventional (no treatment given during course of the study) multi-center (when more than one hospital or medical school team work on a medical research study), study that will enroll participants with rheumatoid arthritis (RA) in Canada. Only data available from source documentation will be collected. The participation in this study will not impact on the standard of care of the participant or any benefits to which they are otherwise entitled. All aspects of treatment decisions and clinical management of participants will be in accordance with clinical practice and at the discretion of the health care provider. Participants' safety will be monitored throughout the study.

Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid Arthritis Observational Golimumab SIMPONI Intravenous Infusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Golimumab Intravenous

Participants with rheumatoid arthritis (RA) in Canada, will be observed for 24 months. Only data available from source documentation will be collected.

Golimumab Intravenous

Intervention Type BIOLOGICAL

This is a non-interventional study. Participants with rheumatoid arthritis in Canada will be observed for 24 months.

Interventions

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Golimumab Intravenous

This is a non-interventional study. Participants with rheumatoid arthritis in Canada will be observed for 24 months.

Intervention Type BIOLOGICAL

Other Intervention Names

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SIMPONI

Eligibility Criteria

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Inclusion Criteria

* Participants must have a confirmed diagnosis of rheumatoid arthritis
* Participants must have provided a written consent for data collection by signing an informed consent form indicating that he/she understand the purpose and procedures for data collection and are willing to participate in the study
* Participants are golimumab-naive (never have used golimumab both SC and IV formulations)
* Participants are prescribed golimumab intravenous by an appropriate physician as per the Canadian Product Monograph

Exclusion Criteria

* Participant who has been treated with golimumab in the past
* Participant has been diagnosed with psoriatic arthritis or ankylosing spondylitis
* Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or first data collection time point
* Participant is currently enrolled in an interventional study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Inc. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Inc.

Locations

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St. John's, Newfoundland and Labrador, Canada

Site Status

Ancaster, Ontario, Canada

Site Status

Barrie, Ontario, Canada

Site Status

Kitchener, Ontario, Canada

Site Status

Mississauga, Ontario, Canada

Site Status

Nepean, Ontario, Canada

Site Status

Oakville, Ontario, Canada

Site Status

St. Catharines, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Laval, Quebec, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Saskatoon, Saskatchewan, Canada

Site Status

Victoria, , Canada

Site Status

Countries

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Canada

Other Identifiers

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CNTO148ARA4003

Identifier Type: OTHER

Identifier Source: secondary_id

CR105631

Identifier Type: -

Identifier Source: org_study_id