NCT02390700

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

March 11, 2015

Last Update Submit

November 16, 2016

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisObservationalGolimumabSIMPONIIntravenous Infusion

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Infusion Reactions

    The count of infusion reactions will be reported.

    Up to end of study (2 years) or early withdrawal

Secondary Outcomes (7)

  • Number of Participants With use of Pre-infusion Medications

    Baseline up to end of study (2 years) or early withdrawal

  • Number of Participants With use of Concomitant Medications at Time of Infusion

    Baseline up to end of study (2 years) or early withdrawal

  • Number of Participants With Infusion Reaction Treatments

    Baseline up to end of study (2 years) or early withdrawal

  • Number of Participants With Subsequent Reactions After the First Infusion Reaction

    Baseline up to end of study (2 years) or early withdrawal

  • Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score

    Baseline up to end of study (2 years) or early withdrawal

  • +2 more secondary outcomes

Study Arms (1)

Golimumab Intravenous

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

Biological: Golimumab Intravenous

Interventions

Golimumab IntravenousBIOLOGICAL

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

Also known as: SIMPONI
Golimumab Intravenous

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Canadian participants with rheumatoid arthritis (RA), who have been prescribed intravenous golimumab prior to, and independently of, study enrollment.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

St. John's, Newfoundland and Labrador, Canada

Location

Unknown Facility

Ancaster, Ontario, Canada

Location

Unknown Facility

Barrie, Ontario, Canada

Location

Unknown Facility

Kitchener, Ontario, Canada

Location

Unknown Facility

Mississauga, Ontario, Canada

Location

Unknown Facility

Nepean, Ontario, Canada

Location

Unknown Facility

Oakville, Ontario, Canada

Location

Unknown Facility

St. Catharines, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Laval, Quebec, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Saskatoon, Saskatchewan, Canada

Location

Unknown Facility

Victoria, Canada

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

golimumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Janssen Inc. Clinical Trial

    Janssen Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 17, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-11

Locations

CA(13)