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

Rheumatoid Arthritis Clinical Trial

— CONIFER  

Official title:

CONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112213
• Other study ID #: ML30088
• Status: Completed
• Start date: January 12, 2017
• Est. completion date: July 17, 2018

Study information

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

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: July 17, 2018
• Est. primary completion date: July 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Germany	Rheumazentrum Kupka	Altenburg
Germany	Praxis für Rheumatologie.	Amberg
Germany	Kerckhoff-Klinik; Rheumatologie&klin.Immunologie	Bad Nauheim
Germany	Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie	Berlin
Germany	Praxis Dr. Silke Zinke	Berlin
Germany	Praxis für Innere Medizin - Rheumatologie	Berlin
Germany	Rheuma Praxis Berlin Sven Remstedt	Berlin
Germany	Schwerpunktpraxis für Rheumatologie und klinische Immunologie an den Kreiskliniken	Burghausen
Germany	Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III	Dresden
Germany	Praxis Dr. med. Semmler; Facharzt für Innere Medizin	Güstrow
Germany	Dres.Karin Babinsky und Anke Liebhaber	Halle
Germany	Praxis für Rheumatologie Dr. med. Hauke E. Heintz	Hamburg/Poppenbüttel
Germany	Rheumatologische Schwerpunktpraxis	Hannover
Germany	Rheumapraxis PD Dr.med. Bernhard Heilig	Heidelberg
Germany	Rheumatologische Facharztpraxis Maren Sieburg	Magdeburg
Germany	Praxis für Innere Medizin und Rheumatologie	Mansfeld
Germany	Praxiszentrum St. Bonifatius	Muenchen
Germany	Praxis Prof. Dr.med. Herbert Kellner	München
Germany	Rheumatologische Praxis	Neubrandenburg
Germany	Praxis Dr.med. Christoph Volberg	Neuss
Germany	Rheumazentrum Neuss Dres. Irmgard Gürtler und Christoph Volberg	Neuss
Germany	Praxis Dr. Albert	Offenburg
Germany	Knappschaftsklinikum Saar GmbH, Krankenhaus Püttlingen	Püttlingen
Germany	Rheumazentrum Ratingen - Studienambulanz	Ratingen
Germany	Praxis Dr.med. Werner A. Biewer	Saarbruecken
Germany	Rheumatologische Schwerpunktpraxis am Feuersee	Stuttgart
Germany	Praxis für Rheumatologie	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of NSAIDs Used During 14 Days Prior to First Tocilizumab Administration		Day -14 to Day 0 (Baseline)
Primary	Amount of NSAIDs Used During 14 Days After 6-8 Weeks of Tocilizumab Administration		14 days after 6-8 weeks of tocilizumab administration
Primary	Amount of NSAIDs Used During 14 Days After 12-16 Weeks of Tocilizumab Administration		14 days after 12-16 weeks of tocilizumab administration
Primary	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 (	Day -14 to Day 0 (Baseline)
Primary	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	14 days after 6-8 weeks of tocilizumab administration
Primary	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	14 days after 12-16 weeks of tocilizumab administration
Secondary	Percentage of Participants Who Take NSAIDs		Day -14 up to approximately Day 126
Secondary	Average Daily Dose of NSAIDs		Day -14 up to approximately Day 126
Secondary	Percentage of Participants Who Take NSAIDs Despite the Presence of Contraindications and Risk Factors		Day -14 up to approximately Day 126
Secondary	Percentage of Participants Who do not Take Gastro-Protection (Proton-Pump Inhibitors [PPIs]) While Using NSAIDs		Day -14 up to approximately Day 126
Secondary	Percentage of NSAID-Prescribers		Day -14 up to approximately Day 126
Secondary	Percentage of NSAID Self-Medication		Day -14 up to approximately Day 126
Secondary	Percentage of Participants Using NSAIDs by Disease Activity		Day -14 up to approximately Day 126
Secondary	Percentage of Participants Using NSAIDs by Disease Duration		Day -14 up to approximately Day 126
Secondary	Percentage of Participants Using NSAIDs by Health Assessment Questionnaire-Disability Index (HAQ-DI) Score		Day -14 up to approximately Day 126
Secondary	HAQ-DI Score		Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants With Adverse Events (AEs)		From Baseline up to approximately Week 28