Golimumab for Adherence in Rheumatoid Arthritis (GO FAR)

July 17, 2024 updated by: Janssen Inc.
The purpose of this study is to determine if non-adherence to Rheumatoid Arthritis (RA) drugs in participants treated with biologic disease modifying anti-rheumatic drugs (DMARDs) is associated with a greater incidence of disease in clinical practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

222

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 3M7
        • Private Practice Dr Louis Bessette
    • Alberta
      • Calgary, Alberta, Canada, T3B 0B2
        • Peak Medical Specialty Centre
    • British Columbia
      • Penticton, British Columbia, Canada, V2A 3G7
        • Jacqueline C Stewart Medical Inc.
      • Victoria, British Columbia, Canada, V8P 5P6
        • Dr. Milton F Baker Inc.
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 6H5
        • Fredericton Medical Clinic
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 5E8
        • Nexus Clinical Research
      • St. John's, Newfoundland and Labrador, Canada, A1C 2E9
        • St Clare's Hospital
    • Nova Scotia
      • Lunenburg, Nova Scotia, Canada, B0J2C0
        • Private Practice - Dr. Diane Wilson
    • Ontario
      • Barrie, Ontario, Canada, L4M 6L2
        • The Waterside Clinic
      • Burlington, Ontario, Canada, L7R 2H3
        • Dr. Sankalp V. Bhavsar Medicine Professional Corporation
      • Dundas, Ontario, Canada, L9H 1B7
        • Private Practice - Dr. Pauline Boulos
      • Etobicoke, Ontario, Canada, M9V 3Z7
        • Dr. Sangeetha Thiviyarajah Medicine Professional Corporation
      • Etobicoke, Ontario, Canada, M9V 5G5
        • Samuel Silverberg Medicine Professional Corporation
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Adachi Medicine Professional Corporation
      • Hamilton, Ontario, Canada, L9C 5N2
        • Manisha Mulgund Medicine Professional Corporation
      • Kitchener, Ontario, Canada, N2M 5N6
        • K-W Musculoskeletal Research Inc
      • Markham, Ontario, Canada, L3R 2C7
        • Markham Rheumatology Hub
      • Mississauga, Ontario, Canada, L5M 2V8
        • Credit Valley Rheumatology
      • Niagara Falls, Ontario, Canada, L2E 6A6
        • Dr. Rajwinder S Dhillon Medicine Professional Corporation
      • Oakville, Ontario, Canada, L6H 3P1
        • Makhzoum Medicine Professional Coporation
      • Oakville, Ontario, Canada, L6M 1M1
        • Dr. S. Gill Medicine Professional Corporation
      • Toronto, Ontario, Canada, M3N 2V6
        • Dr. Abraham Chaiton Medicine Professional Corporation
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Regional Cancer Centre
      • Toronto, Ontario, Canada, M6C 1Y8
        • Arthur Karasik Medicine Professional Corporation
      • Windsor, Ontario, Canada, N8X 1T3
        • Dr. Sabeen Anwar Medicine Professional Corporation
    • Quebec
      • Montreal, Quebec, Canada, H4N 1C6
        • Clinique de Rhumatologie de Montreal
      • Rimouski, Quebec, Canada, G5L 5T1
        • Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • CIUSSS de L Estrie CHUS
      • Sherbrooke, Quebec, Canada, J1J 2E3
        • Clinique Jacques Cartier- Rheumatology Division - Université de Sherbrooke
      • Trois Rivieres, Quebec, Canada, G8Z1Y2
        • Centre de Recherche Musculo Squelettique
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Community Rheumatology Care
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Rheumatology Associates of Saskatoon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All Rheumatoid Arthritis (RA) participants treated with golimumab in a clinical practice setting will be observed.

Description

Inclusion Criteria:

  • Must have a confirmed diagnosis of rheumatoid arthritis
  • About to initiate therapy with golimumab
  • Must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria:

  • Diagnosis of Axial Spondyloarthritis, Ankylosing Spondylitis or Psoriatic Arthritis
  • Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the start of the study or the first data collection time point
  • Currently enrolled in an investigational study
  • Currently enrolled in an observational study sponsored or managed by a Janssen company

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with Diagnosis of Rheumatoid Arthritis
Participants will not receive any intervention as a part of this study. All Rheumatoid Arthritis (RA) participants treated with golimumab in a clinical practice setting will be observed.
Biological: Golimumab
Participants will receive golimumab as a part of clinical practice.
Other Names:
  • SIMPONI ™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Adherence on Flares as Assessed by Rheumatoid Arthritis Flare Questionnaire (RA-FQ) Score at 6 Month
Time Frame: 6 Month
Impact of adherence on flares will be assessed by RA-FQ score or the answer to question 7 of the RA-FQ (Are you having a flare?) at 6 month in participants categorized as "low predicted compliance" vs "high predicted compliance". RA-FQ is 10 point scale for questions 1 to 5, with score range from 0 to 10, where higher score indicates worse outcome and having option 'Yes' and 'No' for question 6 and 7. The RA-FQ total score is calculated as the sum of responses for items 1-5 (maximum 50). Higher score indicates worst outcome.
6 Month
Impact of Adherence on Flares as Assessed by RA-FQ Score at 12 Month
Time Frame: 12 Month
Impact of adherence on flares will be assessed by RA-FQ score or the answer to question 7 of the RA-FQ (Are you having a flare?) at 12 month in participants categorized as "low predicted compliance" vs "high predicted compliance". RA-FQ is 10 point scale for questions 1 to 5, with score range from 0 to 10, where higher score indicates worse outcome and having option 'Yes' and 'No' for question 6 and 7. The RA-FQ total score is calculated as the sum of responses for items 1-5 (maximum 50). Higher score indicates worst outcome.
12 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Adherent Participants at 6 and 12 Months
Time Frame: Months 6 and 12
Percentage of adherent participants at 6 and 12 Months will be assessed.
Months 6 and 12
Number of Participants with Corticosteroid Use
Time Frame: Months 6 and 12
Number of participants with corticosteroid use will be assessed among participants categorized as "low predicted compliance" vs "high predicted compliance" at 6 and 12 months.
Months 6 and 12
Predicting Factors for Adherence
Time Frame: Months 6 and 12
Independent predictors of "predicted compliance" will be assessed with univariate and multivariate Cox regression analysis.
Months 6 and 12
Number of Participants with any Adverse Events (AEs), Serious Adverse Events (SAEs) or Discontinuation of Golimumab
Time Frame: Months 6 and 12
Number of participants with any AEs, SAEs or discontinuation of golimumab will be assessed among participants categorized as "low predicted compliance" vs "high predicted compliance" at 6 and 12 months and include any such event up to the previous study visit.
Months 6 and 12
Percentage of Participants with Response to Patient Support Program Question
Time Frame: Months 6 and 12
Percentage of participants with response to Patient Support Program Question (Yes/No) will be assessed among participants categorized as "low predicted compliance" vs "high predicted compliance" at 6 and 12 months.
Months 6 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Inc.

Investigators

  • Study Director: Janssen Inc. Clinical Trial, Janssen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

June 19, 2023

Study Completion (Actual)

June 19, 2023

Study Registration Dates

First Submitted

November 1, 2018

First Submitted That Met QC Criteria

November 1, 2018

First Posted (Actual)

November 2, 2018

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108555
  • CNTO148ARA4010 (Other Identifier: Janssen Inc.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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