Clinical trial NCT03729349: Golimumab for Adherence in Rheumatoid Arthritis
Official title: Golimumab for Adherence in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Janssen Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-02
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Rheumatoid Arthritis (RA) participants treated with golimumab in a clinical practice setting will be observed.

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.


Eligibility 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

Primary outcomes:
measure: Impact of Adherence on Flares as Assessed by Rheumatoid Arthritis Flare Questionnaire (RA-FQ) Score at 6 Month
timeFrame: 6 Month
measure: Impact of Adherence on Flares as Assessed by RA-FQ Score at 12 Month
timeFrame: 12 Month
Secondary outcomes:
measure: Percentage of Adherent Participants at 6 and 12 Months
timeFrame: Months 6 and 12
measure: Number of Participants with Corticosteroid Use
timeFrame: Months 6 and 12
measure: Predicting Factors for Adherence
timeFrame: Months 6 and 12
measure: Number of Participants with any Adverse Events (AEs), Serious Adverse Events (SAEs) or Discontinuation of Golimumab
timeFrame: Months 6 and 12
measure: Percentage of Participants with Response to Patient Support Program Question
timeFrame: Months 6 and 12
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Peak Medical Specialty Centre
state: Alberta
city: Penticton
country: Canada
facility: Jacqueline C Stewart Medical Inc.
state: British Columbia
city: Victoria
country: Canada
facility: Dr. Milton F Baker Inc.
state: British Columbia
city: Fredericton
country: Canada
facility: Fredericton Medical Clinic
state: New Brunswick
city: St. John's
country: Canada
facility: Nexus Clinical Research
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: St Clare's Hospital
state: Newfoundland and Labrador
city: Lunenburg
country: Canada
facility: Private Practice - Dr. Diane Wilson
state: Nova Scotia
city: Barrie
country: Canada
facility: The Waterside Clinic
state: Ontario
city: Burlington
country: Canada
facility: Dr. Sankalp V. Bhavsar Medicine Professional Corporation
state: Ontario
city: Dundas
country: Canada
facility: Private Practice - Dr. Pauline Boulos
state: Ontario
city: Etobicoke
country: Canada
facility: Dr. Sangeetha Thiviyarajah Medicine Professional Corporation
state: Ontario
city: Etobicoke
country: Canada
facility: Samuel Silverberg Medicine Professional Corporation
state: Ontario
city: Hamilton
country: Canada
facility: Adachi Medicine Professional Corporation
state: Ontario
city: Hamilton
country: Canada
facility: Manisha Mulgund Medicine Professional Corporation
state: Ontario
city: Kitchener
country: Canada
facility: K-W Musculoskeletal Research Inc
state: Ontario
city: Markham
country: Canada
facility: Markham Rheumatology Hub
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Rheumatology
state: Ontario
city: Niagara Falls
country: Canada
facility: Dr. Rajwinder S Dhillon Medicine Professional Corporation
state: Ontario
city: Oakville
country: Canada
facility: Makhzoum Medicine Professional Coporation
state: Ontario
city: Oakville
country: Canada
facility: Dr. S. Gill Medicine Professional Corporation
state: Ontario
city: Toronto
country: Canada
facility: Dr. Abraham Chaiton Medicine Professional Corporation
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Arthur Karasik Medicine Professional Corporation
state: Ontario
city: Windsor
country: Canada
facility: Dr. Sabeen Anwar Medicine Professional Corporation
state: Ontario
city: Montreal
country: Canada
facility: Clinique de Rhumatologie de Montreal
state: Quebec
city: Rimouski
country: Canada
facility: Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de L Estrie CHUS
state: Quebec
city: Sherbrooke
country: Canada
facility: Clinique Jacques Cartier- Rheumatology Division - Université de Sherbrooke
state: Quebec
city: Trois Rivieres
country: Canada
facility: Centre de Recherche Musculo Squelettique
state: Quebec
city: Saskatoon
country: Canada
facility: Community Rheumatology Care
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Rheumatology Associates of Saskatoon
state: Saskatchewan
city: Quebec
country: Canada
facility: Private Practice Dr Louis Bessette
Study officials:
affiliation: Janssen Inc.
name: Janssen Inc. Clinical Trial
role: STUDY_DIRECTOR
References: