Clinical trial NCT03112213: Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment
Official title: CONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-04-13
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Amount of NSAIDs Used During 14 Days Prior to First Tocilizumab Administration
timeFrame: Day -14 to Day 0 (Baseline)
measure: Amount of NSAIDs Used During 14 Days After 6-8 Weeks of Tocilizumab Administration
timeFrame: 14 days after 6-8 weeks of tocilizumab administration
measure: Amount of NSAIDs Used During 14 Days After 12-16 Weeks of Tocilizumab Administration
timeFrame: 14 days after 12-16 weeks of tocilizumab administration
measure: Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days Prior to First Tocilizumab Administration
timeFrame: Day -14 to Day 0 (Baseline)
measure: Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days After 6-8 Weeks of Tocilizumab Administration
timeFrame: 14 days after 6-8 weeks of tocilizumab administration
measure: Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days After 12-16 Weeks of Tocilizumab Administration
timeFrame: 14 days after 12-16 weeks of tocilizumab administration
Secondary outcomes:
measure: Percentage of Participants Who Take NSAIDs
timeFrame: Day -14 up to approximately Day 126
measure: Average Daily Dose of NSAIDs
timeFrame: Day -14 up to approximately Day 126
measure: Percentage of Participants Who Take NSAIDs Despite the Presence of Contraindications and Risk Factors
timeFrame: Day -14 up to approximately Day 126
measure: Percentage of Participants Who do not Take Gastro-Protection (Proton-Pump Inhibitors [PPIs]) While Using NSAIDs
timeFrame: Day -14 up to approximately Day 126
measure: Percentage of NSAID-Prescribers
timeFrame: Day -14 up to approximately Day 126
measure: Percentage of NSAID Self-Medication
timeFrame: Day -14 up to approximately Day 126
measure: Percentage of Participants Using NSAIDs by Disease Activity
timeFrame: Day -14 up to approximately Day 126
measure: Percentage of Participants Using NSAIDs by Disease Duration
timeFrame: Day -14 up to approximately Day 126
measure: Percentage of Participants Using NSAIDs by Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
timeFrame: Day -14 up to approximately Day 126
measure: HAQ-DI Score
timeFrame: Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16
measure: Disease Activity Score Based on 28 Joints (DAS28)
timeFrame: Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16
measure: Clinical Disease Activity Index (CDAI) Score
timeFrame: Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16
measure: Simplified Disease Activity Index (SDAI) Score
timeFrame: Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: From Baseline up to approximately Week 28
Other outcomes:
Locations:
city: Altenburg
country: Germany
facility: Rheumazentrum Kupka
city: Amberg
country: Germany
facility: Praxis für Rheumatologie.
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik; Rheumatologie&klin.Immunologie
city: Berlin
country: Germany
facility: Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie
city: Berlin
country: Germany
facility: Praxis für Innere Medizin - Rheumatologie
city: Berlin
country: Germany
facility: Rheuma Praxis Berlin Sven Remstedt
city: Berlin
country: Germany
facility: Praxis Dr. Silke Zinke
city: Burghausen
country: Germany
facility: Schwerpunktpraxis für Rheumatologie und klinische Immunologie an den Kreiskliniken
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
city: Güstrow
country: Germany
facility: Praxis Dr. med. Semmler; Facharzt für Innere Medizin
city: Halle
country: Germany
facility: Dres.Karin Babinsky und Anke Liebhaber
city: Hamburg/Poppenbüttel
country: Germany
facility: Praxis für Rheumatologie Dr. med. Hauke E. Heintz
city: Hannover
country: Germany
facility: Rheumatologische Schwerpunktpraxis
city: Heidelberg
country: Germany
facility: Rheumapraxis PD Dr.med. Bernhard Heilig
city: Magdeburg
country: Germany
facility: Rheumatologische Facharztpraxis Maren Sieburg
city: Mansfeld
country: Germany
facility: Praxis für Innere Medizin und Rheumatologie
city: Muenchen
country: Germany
facility: Praxiszentrum St. Bonifatius
city: München
country: Germany
facility: Praxis Prof. Dr.med. Herbert Kellner
city: Neubrandenburg
country: Germany
facility: Rheumatologische Praxis
city: Neuss
country: Germany
facility: Rheumazentrum Neuss Dres. Irmgard Gürtler und Christoph Volberg
city: Neuss
country: Germany
facility: Praxis Dr.med. Christoph Volberg
city: Offenburg
country: Germany
facility: Praxis Dr. Albert
city: Püttlingen
country: Germany
facility: Knappschaftsklinikum Saar GmbH, Krankenhaus Püttlingen
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen - Studienambulanz
city: Saarbruecken
country: Germany
facility: Praxis Dr.med. Werner A. Biewer
city: Stuttgart
country: Germany
facility: Rheumatologische Schwerpunktpraxis am Feuersee
city: Ulm
country: Germany
facility: Praxis für Rheumatologie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: