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.

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679001
• Other study ID #: ML29933
• Status: Completed
• Start date: March 24, 2016
• Est. completion date: December 7, 2017

Study information

• Verified date: July 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 7, 2017
• Est. primary completion date: December 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• TNF inhibitor/TCZ
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.

Locations

Country	Name	City	State
Sweden	Arvika Sjukhus; Reumatologimottagningen - Medicinmottagningen	Arvika
Sweden	Mälarsjukhuset; Reumatologkliniken	Eskilstuna
Sweden	Karolinska University Hospital, Huddinge; Rheumatology	Huddinge
Sweden	Blekingesjukhuset Karlskrona; Medicin, Rheumatology	Karlskrona
Sweden	Skånes Universitetssjukhus Malmö; Reumatologkliniken	Malmo
Sweden	Capio Citykliniken, Reumatologen	Malmö
Sweden	Örebro Uni Hospital; Rheumatology	Oerebro
Sweden	Kaernsjukhuset; Dept of Medicine	Skoevde
Sweden	Danderyds Sjukhus Ab; Rheumatology	Stockholm
Sweden	Lasarettet Trelleborg;Reumatologmottagningen	Trelleborg
Sweden	Akademiska sjukhuset, Reumatologkliniken	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with a decrease in dose of oral corticosteroids during the study		From baseline to 6 months
Secondary	Percentage of participants achieving C59CDAI remission (</=2.8)		From baseline to 6 months
Secondary	Percentage of participants achieving CDAI LDA (</=10)		From baseline to 6 months
Secondary	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
Secondary	Percentage of participants for whom non-biologic DMARDs was added during observation period		From baseline to 6 months
Secondary	Percentage of participants with dose change in biological treatment during study		From baseline to 6 months
Secondary	Percentage of participants with use of oral corticosteroids at treatment initiation and at end of study		From baseline to 6 months
Secondary	Percentage of participants who started or stopped oral corticosteroid treatment during the study period		From baseline to 6 months
Secondary	Percentage of participants with increased/decreased/stable dose of corticosteroids from baseline to end of study		From baseline to 6 months
Secondary	Percentage of participants with change in dose of corticosteroids during study but with same dose at study end as at baseline		From baseline to 6 months
Secondary	Cumulated doses of oral corticosteroids during study period		From baseline to 6 months
Secondary	Number of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections		From baseline to 6 months
Secondary	Cumulated doses of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections		From baseline to 6 months
Secondary	Cumulated doses of all corticosteroids during study period		From baseline to 6 months
Secondary	Mean dose of corticosteroids at start and end of study		From baseline to 6 months
Secondary	Mean change from baseline to end of study of corticosteroids		Baseline, Month 6
Secondary	Mean change from baseline to end of study in DAS28 (sedimentation rate [SR]) score		Baseline, Month 6
Secondary	Mean change from baseline to end of study in DAS28 (C-Reactive Protein [CRP]) score		Baseline, Month 6
Secondary	Mean change from baseline to end of study in crohns disease activity index (CDAI) score		Baseline, Month 6
Secondary	Mean change from baseline to end of study in swollen 28 joint count		Baseline, Month 6
Secondary	Mean change from baseline to end of study in tender 28 joint count		Baseline, Month 6
Secondary	Mean change from baseline to end of study in Physician Global Assessment of disease activity (Visual Analogue Scale [VAS] scale)		Baseline, Month 6
Secondary	Mean change from baseline to end of study in Patient Global Assessment of disease activity (VAS scale)		Baseline, Month 6
Secondary	Mean change from baseline to end of study in Health Assessment Questionnaire Disability Index (HAQ-DI)		Baseline, Month 6
Secondary	Mean change from baseline to end of study in Severity of pain (VAS scale)		Baseline, Month 6
Secondary	Mean change from baseline to end of study in EULAR response		Baseline, Month 6
Secondary	Percentage of participants achieving DAS28 remission (less than or equal to [</=] 2.6)		From baseline to 6 months
Secondary	Percentage of participants achieving DAS 28 Low Disease Activity (LDA) (</=3.2)		From baseline to 6 months