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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: TNF inhibitor/TCZ

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Sweden
  • Arvika, Sweden, 671 80
    • Arvika Sjukhus; Reumatologimottagningen - Medicinmottagningen
  • Eskilstuna, Sweden, 631 88
    • Mälarsjukhuset; Reumatologkliniken
  • Huddinge, Sweden, SE-141 86
    • Karolinska University Hospital, Huddinge; Rheumatology
  • Karlskrona, Sweden, 37185
    • Blekingesjukhuset Karlskrona; Medicin, Rheumatology
  • Malmo, Sweden, 205 02
    • Skånes Universitetssjukhus Malmö; Reumatologkliniken
  • Malmö, Sweden, 212 28
    • Capio Citykliniken, Reumatologen
  • Oerebro, Sweden, 70185
    • Örebro Uni Hospital; Rheumatology
  • Skoevde, Sweden, 54185
    • Kaernsjukhuset; Dept of Medicine
  • Stockholm, Sweden, 18288
    • Danderyds Sjukhus Ab; Rheumatology
  • Trelleborg, Sweden, 231 85
    • Lasarettet Trelleborg;Reumatologmottagningen
  • Uppsala, Sweden, 75185
    • Akademiska sjukhuset, Reumatologkliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; Other Names: COTTON

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants with a decrease in dose of oral corticosteroids during the study	From baseline to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 24, 2016
• Primary Completion (ACTUAL): December 7, 2017
• Study Completion (ACTUAL): December 7, 2017

Study Registration Dates

• First Submitted: February 8, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (ESTIMATE): February 10, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Anti-Inflammatory Agents; Tumor Necrosis Factor Inhibitors
• Other Study ID Numbers: ML29933