Golimumab for Adherence in Rheumatoid Arthritis

NCT ID: NCT03729349

Last Updated: 2024-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-15

Study Completion Date

2023-06-19

Brief Summary

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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.

Detailed Description

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Conditions

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Arthritis, Rheumatoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Golimumab

Intervention Type BIOLOGICAL

Participants will receive golimumab as a part of clinical practice.

Interventions

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Golimumab

Participants will receive golimumab as a part of clinical practice.

Intervention Type BIOLOGICAL

Other Intervention Names

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SIMPONI ™

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Inc. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Inc.

Locations

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Peak Medical Specialty Centre

Calgary, Alberta, Canada

Site Status

Jacqueline C Stewart Medical Inc.

Penticton, British Columbia, Canada

Site Status

Dr. Milton F Baker Inc.

Victoria, British Columbia, Canada

Site Status

Fredericton Medical Clinic

Fredericton, New Brunswick, Canada

Site Status

Nexus Clinical Research

St. John's, Newfoundland and Labrador, Canada

Site Status

St Clare's Hospital

St. John's, Newfoundland and Labrador, Canada

Site Status

Private Practice - Dr. Diane Wilson

Lunenburg, Nova Scotia, Canada

Site Status

The Waterside Clinic

Barrie, Ontario, Canada

Site Status

Dr. Sankalp V. Bhavsar Medicine Professional Corporation

Burlington, Ontario, Canada

Site Status

Private Practice - Dr. Pauline Boulos

Dundas, Ontario, Canada

Site Status

Dr. Sangeetha Thiviyarajah Medicine Professional Corporation

Etobicoke, Ontario, Canada

Site Status

Samuel Silverberg Medicine Professional Corporation

Etobicoke, Ontario, Canada

Site Status

Adachi Medicine Professional Corporation

Hamilton, Ontario, Canada

Site Status

Manisha Mulgund Medicine Professional Corporation

Hamilton, Ontario, Canada

Site Status

K-W Musculoskeletal Research Inc

Kitchener, Ontario, Canada

Site Status

Markham Rheumatology Hub

Markham, Ontario, Canada

Site Status

Credit Valley Rheumatology

Mississauga, Ontario, Canada

Site Status

Dr. Rajwinder S Dhillon Medicine Professional Corporation

Niagara Falls, Ontario, Canada

Site Status

Makhzoum Medicine Professional Coporation

Oakville, Ontario, Canada

Site Status

Dr. S. Gill Medicine Professional Corporation

Oakville, Ontario, Canada

Site Status

Dr. Abraham Chaiton Medicine Professional Corporation

Toronto, Ontario, Canada

Site Status

Sunnybrook Regional Cancer Centre

Toronto, Ontario, Canada

Site Status

Arthur Karasik Medicine Professional Corporation

Toronto, Ontario, Canada

Site Status

Dr. Sabeen Anwar Medicine Professional Corporation

Windsor, Ontario, Canada

Site Status

Clinique de Rhumatologie de Montreal

Montreal, Quebec, Canada

Site Status

Private Practice Dr Louis Bessette

Québec, Quebec, Canada

Site Status

Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski

Rimouski, Quebec, Canada

Site Status

CIUSSS de L Estrie CHUS

Sherbrooke, Quebec, Canada

Site Status

Clinique Jacques Cartier- Rheumatology Division - Université de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Centre de Recherche Musculo Squelettique

Trois-Rivières, Quebec, Canada

Site Status

Community Rheumatology Care

Saskatoon, Saskatchewan, Canada

Site Status

Rheumatology Associates of Saskatoon

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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Bessette L, Boulos P, Arendse R, Rahman P, Aseer S, Ruban T, Rachich M, Nantel F, Calce A, Asin-Milan O, Haaland D. Impact of Adherence to Golimumab on Disease Flares in Rheumatoid Arthritis: Results from a Canadian Observational Study. Patient Prefer Adherence. 2025 Jun 25;19:1843-1853. doi: 10.2147/PPA.S516794. eCollection 2025.

Reference Type DERIVED
PMID: 40585577 (View on PubMed)

Other Identifiers

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CNTO148ARA4010

Identifier Type: OTHER

Identifier Source: secondary_id

CR108555

Identifier Type: -

Identifier Source: org_study_id

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