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Trial record 95 of 2723 for:    Rheumatoid Arthritis

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 : July 12, 2019
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, 2020
Estimated Study Completion Date : December 21, 2020

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.



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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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Canada, British Columbia
Jacqueline C Stewart Medical Inc. Not yet recruiting
Penticton, British Columbia, Canada, V2A 3G7
Dr. Milton F Baker Inc. Recruiting
Victoria, British Columbia, Canada, V8P 5P6
Canada, New Brunswick
Fredericton Medical Clinic Recruiting
Fredericton, New Brunswick, Canada, E3B 6H5
Canada, Newfoundland and Labrador
Nexus Clinical Research Recruiting
St. John's, Newfoundland and Labrador, Canada, A1A 5E8
Canada, NFLD
St. Clare's Hospital Recruiting
St. John's, NFLD, Canada, A1C 2E9
Canada, Nova Scotia
Private Practice - Dr. Diane Wilson Recruiting
Lunenburg, Nova Scotia, Canada, B0J2C0
Canada, Ontario
The Waterside Clinic Recruiting
Barrie, Ontario, Canada, L4M 6L2
Dr. Sankalp V. Bhavsar Medicine Professional Corporation Not yet recruiting
Burlington, Ontario, Canada, L7R 2H3
Private Practice - Dr. Pauline Boulos Recruiting
Dundas, Ontario, Canada, L9H 1B7
Dr. Sangeetha Thiviyarajah Medicine Professional Corporation Not yet recruiting
Etobicoke, Ontario, Canada, M9V 3Z7
Samuel Silverberg Medicine Professional Corporation Recruiting
Etobicoke, Ontario, Canada, M9V 5G5
Adachi Medicine Professional Corporation Not yet recruiting
Hamilton, Ontario, Canada, L8N 1Y2
Manisha Mulgund Medicine Professional Corporation Recruiting
Hamilton, Ontario, Canada, L9C 5N2
Credit Valley Rheumatology Recruiting
Mississauga, Ontario, Canada, L5M 2V8
Dr. Rajwinder S Dhillon Medicine Professional Corporation Recruiting
Niagara Falls, Ontario, Canada, L2E 6A6
Dr. Abraham Chaiton Medicine Professional Corporation Not yet recruiting
Toronto, Ontario, Canada, M3N 2V6
Sunnybrook Regional Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Arthur Karasik Medicine Professional Corporation Recruiting
Toronto, Ontario, Canada, M6C 1Y8
Dr. Sabeen Anwar Medicine Professional Corporation Recruiting
Windsor, Ontario, Canada, N8X 1T3
Jude Rodrigues Medicine Professional Corporation Not yet recruiting
Windsor, Ontario, Canada, N8X 2C9
Canada, Quebec
Clinique de Rhumatologie de Montreal Recruiting
Montreal, Quebec, Canada, H4N 1C6
CIUSSS de L'Estrie - CHUS Not yet recruiting
Sherbrooke, Quebec, Canada, J1G 2E8
Centre de Recherche Musculo Squelettique Recruiting
Trois Rivieres, Quebec, Canada, G8Z1Y2
Canada, Saskatchewan
Community Rheumatology Care Recruiting
Saskatoon, Saskatchewan, Canada, S7K 0H6
Rheumatology Associates of Saskatoon Recruiting
Saskatoon, Saskatchewan, Canada, S7K 0H6
Canada
Private Practice - Dr. Louis Bessette Recruiting
Quebec, Canada, G1V 3M7
Clinique Jacques Cartier- Rheumatology Division - Université de Sherbrooke Recruiting
Sherbrooke, Canada, J1J 2E3
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     History of Changes
Other Study ID Numbers: CR108555
CNTO148ARA4010 ( Other Identifier: Janssen Inc. )
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs