Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

— ESCALATE-RA  

Official title:

ESCALATE-RA A NON-INTERVENTIONAL STUDY OF CRITICAL FACTORS FOR ESCALATING DRUG TREATMENT IN PATIENTS TREATED WITH TOFACITINIB FOR MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387423
• Other study ID #: A3921302
• Secondary ID: ESCALATE-RA
• Status: Completed
• Start date: November 2, 2017
• Est. completion date: July 17, 2023

Study information

• Verified date: September 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This non-interventional study aims to identify key factors that are driving treatment decisions by rheumatologists in the treatment of rheumatoid arthritis (RA) patients starting treatment with Tofacitinib in a real world setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1497
• Est. completion date: July 17, 2023
• Est. primary completion date: July 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients aged = 18 years Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist Patient is eligible for Tofacitinib treatment according to Summary of Product Characteristics (SmPC) Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: Contraindications according to Xeljanz® SmPC Receipt of any investigational drug within 3 months before study inclusion Patients who have received any previous treatment with Tofacitinib or other JAK inhibitors Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the study.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Tofacitinib
Patients who are started on Tofacitinib treatment according to the drug label

Locations

Country	Name	City	State
Germany	Private Practice Kupka	Altenburg
Germany	Private Practise Boehm	Altenholz
Germany	Private Practice Marycz	Amberg
Germany	Private Practice Fuchs	Augsburg
Germany	private practise Gause	Bad Bramstedt
Germany	ACURA Kliniken Rheinland-Pfalz AG	Bad Kreuznach
Germany	MFZ Medizinisches Forschungszentrum Weserbergland	Bad Pyrmont
Germany	Private Practice Manger	Bamberg
Germany	Private Practice	Bayreuth
Germany	Private Practice Ochs	Bayreuth
Germany	Private Practice Schmitt-Haendle	Bayreuth
Germany	Ambulantes Gesundheitszentrum der Charité	Berlin
Germany	Privat Practice Remstedt	Berlin
Germany	Private Practice Bozorg	Berlin
Germany	Private Practice Brandt-Juergens	Berlin
Germany	Private Practice Seifert	Berlin
Germany	Private Practice Thiele	Berlin
Germany	Private Practice Zinke	Berlin
Germany	private practise Herzberg	Berlin
Germany	Immanuel Klinikum Bernau	Bernau
Germany	Private Practise	Braunschweig
Germany	MED Bayern OST GmbH	Burghausen
Germany	Private Practice Lorenz	Chemnitz
Germany	Private Practice Kirrstetter	Deggendorf
Germany	Kreiskranenhaus Demmin GmbH	Demmin
Germany	Private Practice Menne	Dortmund
Germany	Private Practice Fischer	Dresden
Germany	Private Practice Luethke	Dresden
Germany	Private Praxis	Duesseldorf	Nordrhein-westfalen
Germany	private practise Pech	Eberswalde
Germany	Private Practice Steinmueller	Ehringshausen
Germany	Asklepios MVZ Nord SH GmbH, c/o AK St. Georg	Elmshorn
Germany	Private Practice Kaestner	Erfurt
Germany	Private Practice Koch	Erfurt
Germany	Private Practice Haeckel	Frankenberg/Sa.
Germany	Private Practice Mueller	Freiberg
Germany	SRH Krankenhaus Waltershausen-Friedrichroda GmbH	Friedrichroda
Germany	Private Practice Abahji	Germering
Germany	Private Practice Sensse	Gifhorn
Germany	Private Practice Holst	Glaisin
Germany	Private Practice Zeh	Goeppingen
Germany	Private Practice Semmler	Guestrow
Germany	private practise Kühne	Haldensleben
Germany	Private Practice Liebhaber	Halle
Germany	Private Practice Dahmen	Hamburg
Germany	private practise Aries	Hamburg
Germany	Private Practice Stille	Hannover
Germany	private practise Heilig	Heidelberg
Germany	private practise Wernicke	Hohen Neuendorf
Germany	Private Practice Kremers	Juelich
Germany	Medius Kliniken gGmbH	Kirchheim unter Teck
Germany	Private Practice Baerlecken	Koeln
Germany	Kreiskrankenhaus Langenau	Langenau
Germany	Private Practice Hamann	Leipzig
Germany	Private Practice Schwarze	Leipzig
Germany	Private Practice Kudela	Magdeburg
Germany	private practise Sieburg	Magdeburg
Germany	Private Practice Rossbach	Mansfeld
Germany	Private Practice Harmuth	Marktredwitz
Germany	Private Practice Worsch	Muehlhausen
Germany	Private Practice Krueger	Muenchen
Germany	Private Practice Raub	Muenster
Germany	Praxis Dr.med. Holger Krauel Facharzt für Innere Medizin und Rheumatologie	Naumburg (Saale)
Germany	Private Practice Berger	Naunhof
Germany	Private Practise	Neubrandenburg
Germany	Private Practice Volberg	Neuss
Germany	MCN Medic Center Nuernberg GmbH	Nuernberg
Germany	Private Practice Goettl	Passau
Germany	Private Practice Graessler	Pirna
Germany	Private Practice Baumann	Plauen
Germany	Knappschaftsklinikum Soor, Klinik fuer Rheumatologie und Klinische Immunologie	Puettlingen
Germany	Private Practice Wassenberg, Koehler, Weier	Ratingen
Germany	Private Practice Richter	Rostock
Germany	private practise Biewer	Saarbrücken
Germany	MVZ Dialysezentrum Schweinfurt	Schweinfurt
Germany	Private Practice	Schwerin
Germany	Private Practice Moebius	Schwerin
Germany	private practise Ständer	Schwerin
Germany	Private Practice Melzer	Seesen
Germany	MVZ Klinikum Straubing	Straubing
Germany	Private Practice	Templin
Germany	Private Practice Pyra	Torgelow
Germany	Private Practice Haas	Tuebingen
Germany	Klinik an der Weissenburg GmbH	Uhlstaedt-Kirchhasel
Germany	Private Practice Rinaldi	Ulm
Germany	Private Practice Woerth	Wiesbaden
Germany	Klinikverbund St. Antonius und St. Josef GmbH	Wuppertal
Germany	Rheuma Praxis Barmen Dres. med. Demirel / Hruschka	Wuppertal
Germany	Private Practice	Zschopau	Sachsen
Germany	Private Practice Fricke-Wagner	Zwickau
Germany	Private Practice Alliger	Zwiesel

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of DAS28 on the number of treatment escalations of Tofacitinib patients	Impact of DAS28-4 with Erythrocyte Sedimentation Rate (ESR) on the number of treatment escalations of Tofacitinib patients in 24 months.; Treatment escalation in this study is defined as a switch to another DMARD or combination of DMARDs when compared to the last visit.	24 months
Primary	Impact of ?DAS28 on the number of treatment escalations of Tofacitinib patients	Impact of ?DAS28-4 (ESR) on the number of treatment escalations of Tofacitinib patients in 24 months.; Treatment escalation in this study is defined as a switch to another DMARD or combination of DMARDs when compared to the last visit.	24 months
Primary	Impact of Physician Global Assessment of Arthritis on the number of treatment escalations of Tofacitinib patients	Impact of Physician Global Assessment of Arthritis on the number of treatment escalations of Tofacitinib patients in 24 months.; Treatment escalation in this study is defined as a switch to another DMARD or combination of DMARDs when compared to the last visit.	24 months
Primary	Impact of Patient´s Assessment of Arthritis Pain on the number of treatment escalations of Tofacitinib patients	Impact of Patient's Assessment of Arthritis Pain on the number of treatment escalations of Tofacitinib patients in 24 months.; Treatment escalation in this study is defined as a switch to another DMARD or combination of DMARDs when compared to the last visit.	24 months
Primary	Impact of Patient´s satisfaction with drug treatment on the number of treatment escalations of Tofacitinib patients	Impact of Patient's satisfaction with drug treatment on the number of treatment escalations of Tofacitinib patients in 24 months.; Treatment escalation in this study is defined as a switch to another DMARD or combination of DMARDs when compared to the last visit.	24 months
Primary	Impact of Patient´s Global Assessment of Arthritis on the number of treatment escalations of Tofacitinib patients	Impact of Patient's Global Assessment of Arthritis on the number of treatment escalations of Tofacitinib patients in 24 months.; Treatment escalation in this study is defined as a switch to another DMARD or combination of DMARDs when compared to the last visit.	24 months
Secondary	Time to first treatment escalation	Time to first treatment escalation	24 months
Secondary	Rate of Low Disease Activity over time of patients on Tofacitinib	Rate of Low Disease Activity (LDA) over time of patients on Tofacitinib (in combination therapy or monotherapy), as assessed by: Simplified Disease Activity Index (SDAI) = 11; Clinical Disease Activity Index (CDAI) =10; DAS 28 4 (ESR) =3.2 and DAS28 4 with C-reactive Protein (CRP) =3.2. All of these Disease Activity Indicators are criteria for effectiveness. Effectiveness is defined precisely through individual numeric values.	24 months
Secondary	Rate of remission over time of patients on Tofacitinib	Rate of remission over time of patients on Tofacitinib (in combination therapy or monotherapy), as assessed by: American College of Rheumatology (ACR) EULAR Boolean remission criteria; SDAI = 3.3; CDAI =2.8; DAS28 4 (ESR) < 2.6 and DAS28 4 (CRP) < 2.6. All of these Disease Activity Indicators are "American College of Rheumatology (ACR) EULAR Boolean remission criteria". The criteria are defined precisely through individual numeric values.	24 months
Secondary	Change from baseline over time of patients on Tofacitinib	Change from baseline over time of patients on Tofacitinib (in combination therapy or monotherapy) in DAS 28-4 (ESR) and DAS 28-4 (CRP)	24 months
Secondary	Change from baseline of duration of morning stiffness over time of patients on Tofacitinib	Change from baseline of duration of morning stiffness over time of patients on Tofacitinib (in combination therapy or monotherapy)	24 months
Secondary	Change from baseline in the Functional Ability Questionnaire Hannover over time of patients on Tofacitinib	Change from baseline in the Functional Ability Questionnaire Hannover (FFbH) over time of patients on Tofacitinib (in combination therapy or monotherapy)	24 months
Secondary	Rate of patients with functional remission in FFbH (FFbH > 83%) over time of patients on Tofacitinib	Rate of patients with functional remission in FFbH (FFbH > 83%) over time of patients on Tofacitinib (in combination therapy or monotherapy). The FFbH for RA is a German Short questionnaire for the assessment of patientive functional capacity in the context of basic everyday activities (range: 0-100% functional capacity). Functional remission in FFbH is defined as functional capacity > 83 %.	24 months
Secondary	Change from baseline in the EuroQoL EQ-5D questionnaire over time of patients on Tofacitinib	Change from baseline in a self-report questionnaire (a quality of life instrument) developed by the European Quality of Life (EuroQoL) Group (EuroQoL EQ-5D) over time of patients on Tofacitinib (in combination therapy or monotherapy)	24 months
Secondary	Change from baseline on FACIT Fatigue scale over time of patients on Tofacitinib	Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale over time of patients on Tofacitinib (in combination therapy or monotherapy). Fatigue Scale is a patient completed questionnaire consisting of 13 items that assess fatigue. Instrument scoring yields a range from 0 to 52, with higher scores representing better patient status (less fatigue).	24 months
Secondary	Drug survival at month 12 of patients on Tofacitinib	Drug survival at month 12 of patients on Tofacitinib (in combination therapy or monotherapy)	12 months
Secondary	Drug survival at month 24 of patients on Tofacitinib	Drug survival at month 24 of patients on Tofacitinib (in combination therapy or monotherapy)	24 months
Secondary	Patient's satisfaction with Tofacitinib treatment over time	Patient's satisfaction with Tofacitinib treatment (in combination therapy or monotherapy) over time. Satisfaction with treatment will be assessed on a 5-point Likert scale (where 0 = extremely dissatisfied, 1= dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = extremely satisfied) in response to the question "How satisfied are you with the drugs that you have received for your arthritis since your last visit?".	24 months

External Links

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