Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment
- Registration Number
- NCT03112213
- Lead Sponsor
- Hoffmann-La Roche
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
- 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
- Contraindications to treatment with tocilizumab as per SPC
- Prior therapy with tocilizumab
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants With RA NSAIDs 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. Participants With RA Tocilizumab 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.
- Primary Outcome Measures
Name Time Method 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 Prior to First Tocilizumab Administration Day -14 to Day 0 (Baseline) 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 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 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 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 Outcome Measures
Name Time Method Percentage of Participants Who Take NSAIDs 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 Average Daily Dose of NSAIDs Day -14 up to approximately Day 126 Percentage of NSAID-Prescribers 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 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 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 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
Trial Locations
- Locations (27)
Praxis Prof. Dr.med. Herbert Kellner
🇩🇪München, Germany
Rheumazentrum Kupka
🇩🇪Altenburg, Germany
Praxis für Rheumatologie.
🇩🇪Amberg, Germany
Kerckhoff-Klinik; Rheumatologie&klin.Immunologie
🇩🇪Bad Nauheim, Germany
Praxis Dr. Silke Zinke
🇩🇪Berlin, Germany
Schwerpunktpraxis für Rheumatologie und klinische Immunologie an den Kreiskliniken
🇩🇪Burghausen, Germany
Rheumatologische Praxis
🇩🇪Neubrandenburg, Germany
Praxis Dr. Albert
🇩🇪Offenburg, Germany
Rheumazentrum Neuss Dres. Irmgard Gürtler und Christoph Volberg
🇩🇪Neuss, Germany
Praxis Dr.med. Christoph Volberg
🇩🇪Neuss, Germany
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
🇩🇪Dresden, Germany
Dres.Karin Babinsky und Anke Liebhaber
🇩🇪Halle, Germany
Praxis Dr. med. Semmler; Facharzt für Innere Medizin
🇩🇪Güstrow, Germany
Rheumatologische Schwerpunktpraxis
🇩🇪Hannover, Germany
Praxis für Rheumatologie Dr. med. Hauke E. Heintz
🇩🇪Hamburg/Poppenbüttel, Germany
Knappschaftsklinikum Saar GmbH, Krankenhaus Püttlingen
🇩🇪Püttlingen, Germany
Rheumatologische Schwerpunktpraxis am Feuersee
🇩🇪Stuttgart, Germany
Praxis für Rheumatologie
🇩🇪Ulm, Germany
Praxis Dr.med. Werner A. Biewer
🇩🇪Saarbruecken, Germany
Rheumapraxis PD Dr.med. Bernhard Heilig
🇩🇪Heidelberg, Germany
Praxiszentrum St. Bonifatius
🇩🇪Muenchen, Germany
Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie
🇩🇪Berlin, Germany
Praxis für Innere Medizin und Rheumatologie
🇩🇪Mansfeld, Germany
Rheuma Praxis Berlin Sven Remstedt
🇩🇪Berlin, Germany
Praxis für Innere Medizin - Rheumatologie
🇩🇪Berlin, Germany
Rheumatologische Facharztpraxis Maren Sieburg
🇩🇪Magdeburg, Germany
Rheumazentrum Ratingen - Studienambulanz
🇩🇪Ratingen, Germany