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OpenTrials
Completed

NCT Number: NCT03729349

Golimumab for Adherence in Rheumatoid Arthritis

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.

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peak Medical Specialty Centre, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Golimumab

Biological

Participants will receive golimumab as a part of clinical practice.

Other names: SIMPONI ™

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Janssen Inc.

Industry

Registry information

Acronym: GO FAR

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2018
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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