Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment

Overview

This nationwide, multicenter, single arm, prospective, non-interventional study will evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use in a representative cohort of participant with moderate to severe active RA who have either responded inadequately to, or who were intolerant to previous therapy with one or more synthetic disease modifying anti-rheumatic drug (sDMARD), and for whom the physician has made the individual decision to initiate tocilizumab (subcutaneous [SC] or intravenous [IV]) as first biological disease modifying anti-rheumatic drug (DMARD) therapy according to the summary of product characteristics (SPC).

Full Title of Study: “CONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 17, 2018

Interventions

  • Drug: Tocilizumab
    • Tocilizumab (SC or IV) will be prescribed according to local clinical practice and the SPC.
  • Drug: NSAIDs
    • Participants may receive NSAIDs, as prescribed by the treating physician or by self medication. Study protocol does not enforce any particular NSAID.

Arms, Groups and Cohorts

  • Participants With RA
    • Participants with RA who are being treated with tocilizumab and NSAIDs will be observed for approximately 6 months to evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use.

Clinical Trial Outcome Measures

Primary Measures

  • Amount of NSAIDs Used During 14 Days Prior to First Tocilizumab Administration
    • Time Frame: Day -14 to Day 0 (Baseline)
  • Amount of NSAIDs Used During 14 Days After 6-8 Weeks of Tocilizumab Administration
    • Time Frame: 14 days after 6-8 weeks of tocilizumab administration
  • Amount of NSAIDs Used During 14 Days After 12-16 Weeks of Tocilizumab Administration
    • Time Frame: 14 days after 12-16 weeks of tocilizumab administration
  • Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days Prior to First Tocilizumab Administration
    • Time Frame: Day -14 to Day 0 (Baseline)
    • NSAIDs high-dose refers to mean defined daily dose (DDD) greater than (>) 100 percent (%) and low-dose refers to mean DDD lesser than or equal to (</=) 100%.
  • Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days After 6-8 Weeks of Tocilizumab Administration
    • Time Frame: 14 days after 6-8 weeks of tocilizumab administration
    • NSAIDs high-dose refers to mean DDD >100% and low-dose refers to mean DDD </=100%.
  • Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days After 12-16 Weeks of Tocilizumab Administration
    • Time Frame: 14 days after 12-16 weeks of tocilizumab administration
    • NSAIDs high-dose refers to mean DDD >100% and low-dose refers to mean DDD </=100%.

Secondary Measures

  • Percentage of Participants Who Take NSAIDs
    • Time Frame: Day -14 up to approximately Day 126
  • Average Daily Dose of NSAIDs
    • Time Frame: Day -14 up to approximately Day 126
  • Percentage of Participants Who Take NSAIDs Despite the Presence of Contraindications and Risk Factors
    • Time Frame: Day -14 up to approximately Day 126
  • Percentage of Participants Who do not Take Gastro-Protection (Proton-Pump Inhibitors [PPIs]) While Using NSAIDs
    • Time Frame: Day -14 up to approximately Day 126
  • Percentage of NSAID-Prescribers
    • Time Frame: Day -14 up to approximately Day 126
  • Percentage of NSAID Self-Medication
    • Time Frame: Day -14 up to approximately Day 126
  • Percentage of Participants Using NSAIDs by Disease Activity
    • Time Frame: Day -14 up to approximately Day 126
  • Percentage of Participants Using NSAIDs by Disease Duration
    • Time Frame: Day -14 up to approximately Day 126
  • Percentage of Participants Using NSAIDs by Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
    • Time Frame: Day -14 up to approximately Day 126
  • HAQ-DI Score
    • Time Frame: Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16
  • Disease Activity Score Based on 28 Joints (DAS28)
    • Time Frame: Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16
  • Clinical Disease Activity Index (CDAI) Score
    • Time Frame: Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16
  • Simplified Disease Activity Index (SDAI) Score
    • Time Frame: Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16
  • Percentage of Participants With Adverse Events (AEs)
    • Time Frame: From Baseline up to approximately Week 28

Participating in This Clinical Trial

Inclusion Criteria

  • Participants with moderate to severe active RA who have either responded inadequately to, or who were intolerant to, previous therapy with one or more sDMARDs and for whom the physician has made the individual decision to be treated with tocilizumab (SC or IV) – Current users of NSAIDs due to RA as assessed by the physician Exclusion Criteria:

  • Contraindications to treatment with tocilizumab as per SPC – Prior therapy with tocilizumab

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trials, Study Director, Hoffmann-La Roche

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