Clinical trial NCT02679001: 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.
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-02-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Percentage of participants with a decrease in dose of oral corticosteroids during the study
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Percentage of participants achieving C59CDAI remission (</=2.8)
timeFrame: From baseline to 6 months
measure: Percentage of participants achieving CDAI LDA (</=10)
timeFrame: From baseline to 6 months
measure: Percentage of participants using non-biologic disease-modifying anti-rheumatic drugs (C58MARDs) at treatment initiation and at the end of observation period
timeFrame: Baseline, Month 6
measure: Percentage of participants for whom non-biologic DMARDs was added during observation period
timeFrame: From baseline to 6 months
measure: Percentage of participants with dose change in biological treatment during study
timeFrame: From baseline to 6 months
measure: Percentage of participants with use of oral corticosteroids at treatment initiation and at end of study
timeFrame: From baseline to 6 months
measure: Percentage of participants who started or stopped oral corticosteroid treatment during the study period
timeFrame: From baseline to 6 months
measure: Percentage of participants with increased/decreased/stable dose of corticosteroids from baseline to end of study
timeFrame: From baseline to 6 months
measure: Percentage of participants with change in dose of corticosteroids during study but with same dose at study end as at baseline
timeFrame: From baseline to 6 months
measure: Cumulated doses of oral corticosteroids during study period
timeFrame: From baseline to 6 months
measure: Number of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections
timeFrame: From baseline to 6 months
measure: Cumulated doses of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections
timeFrame: From baseline to 6 months
measure: Cumulated doses of all corticosteroids during study period
timeFrame: From baseline to 6 months
measure: Mean dose of corticosteroids at start and end of study
timeFrame: From baseline to 6 months
measure: Mean change from baseline to end of study of corticosteroids
timeFrame: Baseline, Month 6
measure: Mean change from baseline to end of study in DAS28 (sedimentation rate [SR]) score
timeFrame: Baseline, Month 6
measure: Mean change from baseline to end of study in DAS28 (C-Reactive Protein [CRP]) score
timeFrame: Baseline, Month 6
measure: Mean change from baseline to end of study in crohns disease activity index (CDAI) score
timeFrame: Baseline, Month 6
measure: Mean change from baseline to end of study in swollen 28 joint count
timeFrame: Baseline, Month 6
measure: Mean change from baseline to end of study in tender 28 joint count
timeFrame: Baseline, Month 6
measure: Mean change from baseline to end of study in Physician Global Assessment of disease activity (Visual Analogue Scale [VAS] scale)
timeFrame: Baseline, Month 6
measure: Mean change from baseline to end of study in Patient Global Assessment of disease activity (VAS scale)
timeFrame: Baseline, Month 6
measure: Mean change from baseline to end of study in Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Baseline, Month 6
measure: Mean change from baseline to end of study in Severity of pain (VAS scale)
timeFrame: Baseline, Month 6
measure: Mean change from baseline to end of study in EULAR response
timeFrame: Baseline, Month 6
measure: Percentage of participants achieving DAS28 remission (less than or equal to [</=] 2.6)
timeFrame: From baseline to 6 months
measure: Percentage of participants achieving DAS 28 Low Disease Activity (LDA) (</=3.2)
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
city: Arvika
country: Sweden
facility: Arvika Sjukhus; Reumatologimottagningen - Medicinmottagningen
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset; Reumatologkliniken
city: Huddinge
country: Sweden
facility: Karolinska University Hospital, Huddinge; Rheumatology
city: Karlskrona
country: Sweden
facility: Blekingesjukhuset Karlskrona; Medicin, Rheumatology
city: Malmo
country: Sweden
facility: Skånes Universitetssjukhus Malmö; Reumatologkliniken
city: Malmö
country: Sweden
facility: Capio Citykliniken, Reumatologen
city: Oerebro
country: Sweden
facility: Örebro Uni Hospital; Rheumatology
city: Skoevde
country: Sweden
facility: Kaernsjukhuset; Dept of Medicine
city: Stockholm
country: Sweden
facility: Danderyds Sjukhus Ab; Rheumatology
city: Trelleborg
country: Sweden
facility: Lasarettet Trelleborg;Reumatologmottagningen
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset, Reumatologkliniken
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: