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NCT03729349 Clinical Trial

Golimumab for Adherence in Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

— GO FAR  

Official title:
Golimumab for Adherence in Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03729349
Other study ID # CR108555
Secondary ID CNTO148ARA4010
Status Completed
Phase
First received
Last updated
Start date January 15, 2019
Est. completion date June 19, 2023

Study information
Verified date August 2023
Source Janssen Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 222
Est. completion date June 19, 2023
Est. primary completion date June 19, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Golimumab
Participants will receive golimumab as a part of clinical practice.

Locations
Country Name City State
Canada The Waterside Clinic Barrie Ontario
Canada Dr. Sankalp V. Bhavsar Medicine Professional Corporation Burlington Ontario
Canada Peak Medical Specialty Centre Calgary Alberta
Canada Private Practice - Dr. Pauline Boulos Dundas Ontario
Canada Dr. Sangeetha Thiviyarajah Medicine Professional Corporation Etobicoke Ontario
Canada Samuel Silverberg Medicine Professional Corporation Etobicoke Ontario
Canada Fredericton Medical Clinic Fredericton New Brunswick
Canada Adachi Medicine Professional Corporation Hamilton Ontario
Canada Manisha Mulgund Medicine Professional Corporation Hamilton Ontario
Canada K-W Musculoskeletal Research Inc Kitchener Ontario
Canada Private Practice - Dr. Diane Wilson Lunenburg Nova Scotia
Canada Markham Rheumatology Hub Markham Ontario
Canada Credit Valley Rheumatology Mississauga Ontario
Canada Clinique de Rhumatologie de Montreal Montreal Quebec
Canada Dr. Rajwinder S Dhillon Medicine Professional Corporation Niagara Falls Ontario
Canada Dr. S. Gill Medicine Professional Corporation Oakville Ontario
Canada Makhzoum Medicine Professional Coporation Oakville Ontario
Canada Jacqueline C Stewart Medical Inc. Penticton British Columbia
Canada Private Practice - Dr. Louis Bessette Quebec
Canada Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski Rimouski
Canada Community Rheumatology Care Saskatoon Saskatchewan
Canada Rheumatology Associates of Saskatoon Saskatoon Saskatchewan
Canada CIUSSS de L'Estrie - CHUS Sherbrooke Quebec
Canada Clinique Jacques Cartier- Rheumatology Division - Université de Sherbrooke Sherbrooke
Canada Nexus Clinical Research St. John's Newfoundland and Labrador
Canada St. Clare's Hospital St. John's NFLD
Canada Arthur Karasik Medicine Professional Corporation Toronto Ontario
Canada Dr. Abraham Chaiton Medicine Professional Corporation Toronto Ontario
Canada Sunnybrook Regional Cancer Centre Toronto Ontario
Canada Centre de Recherche Musculo Squelettique Trois Rivieres Quebec
Canada Dr. Milton F Baker Inc. Victoria British Columbia
Canada Dr. Sabeen Anwar Medicine Professional Corporation Windsor Ontario

Sponsors (1)
Lead Sponsor Collaborator
Janssen Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Impact of Adherence on Flares as Assessed by Rheumatoid Arthritis Flare Questionnaire (RA-FQ) Score at 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
Primary Impact of Adherence on Flares as Assessed by RA-FQ Score at 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 Percentage of Adherent Participants at 6 and 12 Months Percentage of adherent participants at 6 and 12 Months will be assessed. Months 6 and 12
Secondary Number of Participants with Corticosteroid Use 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
Secondary Predicting Factors for Adherence Independent predictors of "predicted compliance" will be assessed with univariate and multivariate Cox regression analysis. Months 6 and 12
Secondary Number of Participants with any Adverse Events (AEs), Serious Adverse Events (SAEs) or Discontinuation of Golimumab 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
Secondary Percentage of Participants with Response to Patient Support Program Question 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
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