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

CONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis)

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).

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Tocilizumab; Drug: NSAIDs

• Study Type: Observational
• Enrollment (Anticipated): 135

Contacts and Locations

Study Locations

• Germany
  • Altenburg, Germany, 04600
    • Rheumazentrum Kupka
  • Amberg, Germany, 92224
    • Praxis für Rheumatologie.
  • Bad Nauheim, Germany, 61231
    • Kerckhoff-Klinik; Rheumatologie&klin.Immunologie
  • Berlin, Germany, 10117
    • Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie
  • Berlin, Germany, 12435
    • Praxis für Innere Medizin - Rheumatologie
  • Berlin, Germany, 12435
    • Rheuma Praxis Berlin Sven Remstedt
  • Berlin, Germany, 13055
    • Praxis Dr. Silke Zinke
  • Burghausen, Germany, 84489
    • Schwerpunktpraxis für Rheumatologie und klinische Immunologie an den Kreiskliniken
  • Dresden, Germany, 01307
    • Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
  • Güstrow, Germany, 18273
    • Praxis Dr. med. Semmler; Facharzt für Innere Medizin
  • Halle, Germany, 06128
    • Dres.Karin Babinsky und Anke Liebhaber
  • Hamburg/Poppenbüttel, Germany, 22391
    • Praxis für Rheumatologie Dr. med. Hauke E. Heintz
  • Hannover, Germany, 30161
    • Rheumatologische Schwerpunktpraxis
  • Heidelberg, Germany, 69120
    • Rheumapraxis PD Dr.med. Bernhard Heilig
  • Magdeburg, Germany, 39104
    • Rheumatologische Facharztpraxis Maren Sieburg
  • Mansfeld, Germany, 06343
    • Praxis fur Innere Medizin und Rheumatologie
  • Muenchen, Germany, 81541
    • Praxiszentrum St. Bonifatius
  • München, Germany, 80935
    • Praxis Prof. Dr.med. Herbert Kellner
  • Neubrandenburg, Germany, 17033
    • Rheumatologische Praxis
  • Neuss, Germany, 41460
    • Rheumazentrum Neuss Dres. Irmgard Gürtler und Christoph Volberg
  • Neuss, Germany, 41462
    • Praxis Dr.med. Christoph Volberg
  • Offenburg, Germany, 77652
    • Praxis Dr. Albert
  • Püttlingen, Germany, 66346
    • Knappschaftsklinikum Saar GmbH, Krankenhaus Püttlingen
  • Ratingen, Germany, 40878
    • Rheumazentrum Ratingen - Studienambulanz
  • Saarbruecken, Germany, 66111
    • Praxis Dr.med. Werner A. Biewer
  • Stuttgart, Germany, 70178
    • Rheumatologische Schwerpunktpraxis am Feuersee
  • Ulm, Germany, 89073
    • Praxis für Rheumatologie

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Tocilizumab; Tocilizumab (SC or IV) will be prescribed according to local clinical practice and the SPC.; Other Names: RoACTEMRA®; Drug: NSAIDs; Participants may receive NSAIDs, as prescribed by the treating physician or by self medication. Study protocol does not enforce any particular NSAID.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of NSAIDs Used During 14 Days Prior to First Tocilizumab Administration		Day -14 to Day 0 (Baseline)
Amount of NSAIDs Used During 14 Days After 6-8 Weeks of Tocilizumab Administration		14 days after 6-8 weeks of tocilizumab administration
Amount of NSAIDs Used During 14 Days After 12-16 Weeks of Tocilizumab Administration		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	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%.	Day -14 to Day 0 (Baseline)
Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 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%.	14 days after 6-8 weeks of tocilizumab administration
Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 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%.	14 days after 12-16 weeks of tocilizumab administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Who Take NSAIDs	Day -14 up to approximately Day 126
Average Daily Dose of NSAIDs	Day -14 up to approximately Day 126
Percentage of Participants Who Take NSAIDs Despite the Presence of Contraindications and Risk Factors	Day -14 up to approximately Day 126
Percentage of Participants Who do not Take Gastro-Protection (Proton-Pump Inhibitors [PPIs]) While Using NSAIDs	Day -14 up to approximately Day 126
Percentage of NSAID-Prescribers	Day -14 up to approximately Day 126
Percentage of NSAID Self-Medication	Day -14 up to approximately Day 126
Percentage of Participants Using NSAIDs by Disease Activity	Day -14 up to approximately Day 126
Percentage of Participants Using NSAIDs by Disease Duration	Day -14 up to approximately Day 126
Percentage of Participants Using NSAIDs by Health Assessment Questionnaire-Disability Index (HAQ-DI) Score	Day -14 up to approximately Day 126
HAQ-DI Score	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)	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	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	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)	From Baseline up to approximately Week 28

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2017
• Primary Completion (Actual): July 17, 2018
• Study Completion (Actual): July 17, 2018

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 12, 2018
• Last Verified: December 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
• Other Study ID Numbers: ML30088

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No