A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment.
A COMPARATIVE OBSERVATIONAL STUDY FOLLOWING THE USE OF CONCOMITANT CORTICOSTEROID TREATMENT IN RA PATIENTS WHO ARE TREATED WITH A TNF INHIBITOR OR TOCILIZUMAB AS THEIR SECOND BIOLOGICAL TREATMENT
1 other identifier
observational
200
1 country
11
Brief Summary
This six months non-interventional, observational, post-marketing, multi-center and local study will evaluate the differences in the use of corticosteroids between RA participants receiving TCZ or a TNF-inhibitor, in participants who have discontinued the use of a TNF-inhibitor as their first biological treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2016
CompletedFirst Posted
Study publicly available on registry
February 10, 2016
CompletedStudy Start
First participant enrolled
March 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2017
CompletedJuly 26, 2018
July 1, 2018
1.7 years
February 8, 2016
July 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of participants with a decrease in dose of oral corticosteroids during the study
From baseline to 6 months
Secondary Outcomes (27)
Percentage of participants achieving C59CDAI remission (</=2.8)
From baseline to 6 months
Percentage of participants achieving CDAI LDA (</=10)
From baseline to 6 months
Percentage of participants using non-biologic disease-modifying anti-rheumatic drugs (C58MARDs) at treatment initiation and at the end of observation period
Baseline, Month 6
Percentage of participants for whom non-biologic DMARDs was added during observation period
From baseline to 6 months
Percentage of participants with dose change in biological treatment during study
From baseline to 6 months
- +22 more secondary outcomes
Study Arms (1)
RA participants treated with a TNF inhibitor or TCZ
Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling will be observed.
Interventions
Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current SPC/local labeling will be observed.
Eligibility Criteria
Participants with a diagnosis of moderate to severe RA according to the revised (1987) ACR criteria or 2010 ACR/EULAR RA classification criteria who have had an insufficient response or intolerance to their first TNF-inhibitor.
You may qualify if:
- At least 18 years of age.
- With a diagnosis of moderate to severe RA according to the revised (1987) American College of Rheumatology (ACR) criteria or 2010 ACR/ European League Against Rheumatism (EULAR) RA classification criteria.
- Have had an insufficient response or intolerance to their first TNF-inhibitor (including biosimilars for TNF-inhibitors).
- The treating physician has made the decision to commence TCZ or TNF-inhibitor treatment. Participants need to have a Disease Activity Score (DAS) 28 assessment at initiation of their second biological treatment.
- Have been given oral and written information about the study and have no objection to the data concerning him/her being subject to computerized data processing, have given informed consent.
You may not qualify if:
- Have had more than one TNF-inhibitor prior to the enrolment visit.
- Have had biological treatment other than TNF-inhibitors.
- Participants that are continuously treated with per oral corticosteroids for any other indication than RA (at baseline).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Arvika Sjukhus; Reumatologimottagningen - Medicinmottagningen
Arvika, 671 80, Sweden
Mälarsjukhuset; Reumatologkliniken
Eskilstuna, 631 88, Sweden
Karolinska University Hospital, Huddinge; Rheumatology
Huddinge, SE-141 86, Sweden
Blekingesjukhuset Karlskrona; Medicin, Rheumatology
Karlskrona, 37185, Sweden
Skånes Universitetssjukhus Malmö; Reumatologkliniken
Malmo, 205 02, Sweden
Capio Citykliniken, Reumatologen
Malmo, 212 28, Sweden
Örebro Uni Hospital; Rheumatology
Örebro, 70185, Sweden
Kaernsjukhuset; Dept of Medicine
Skövde, 54185, Sweden
Danderyds Sjukhus Ab; Rheumatology
Stockholm, 18288, Sweden
Lasarettet Trelleborg;Reumatologmottagningen
Trelleborg, 231 85, Sweden
Akademiska sjukhuset, Reumatologkliniken
Uppsala, 75185, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2016
First Posted
February 10, 2016
Study Start
March 24, 2016
Primary Completion
December 7, 2017
Study Completion
December 7, 2017
Last Updated
July 26, 2018
Record last verified: 2018-07