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Trial record 1 of 1 for:    CNTO148ARA4010
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Golimumab for Adherence in Rheumatoid Arthritis (GO FAR)

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: NCT03729349
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Arthritis, Rheumatoid Biological: Golimumab

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Golimumab for Adherence in Rheumatoid Arthritis
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 21, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Golimumab

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 Name: SIMPONI ™




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

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): NCT03729349


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Sponsors and Collaborators
Janssen Inc.
Investigators
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Study Director: Janssen Inc. Clinical Trial Janssen Inc.
Additional Information:
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Responsible Party: Janssen Inc.
ClinicalTrials.gov Identifier: NCT03729349    
Other Study ID Numbers: CR108555
CNTO148ARA4010 ( Other Identifier: Janssen Inc. )
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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