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

NCT ID: NCT03387423

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1459 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-02
• Study Completion Date: 2023-07-17

Brief 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.

Conditions

Arthritis, Rheumatoid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Tofacitinib

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Private Praxis

Düsseldorf, North Rhine-Westphalia, Germany

Private Practice

Zschopau, Saxony, 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 Ochs

Bayreuth, , Germany

Private Practice Schmitt-Haendle

Bayreuth, , Germany

Private Practice

Bayreuth, , Germany

Ambulantes Gesundheitszentrum der Charité

Berlin, , Germany

Private Practice Bozorg

Berlin, , Germany

Private Practice Brandt-Juergens

Berlin, , Germany

Privat Practice Remstedt

Berlin, , Germany

private practise Herzberg

Berlin, , Germany

Private Practice Seifert

Berlin, , Germany

Private Practice Zinke

Berlin, , Germany

Private Practice Thiele

Berlin, , Germany

Immanuel Klinikum Bernau

Bernau, , Germany

Private Practise

Braunschweig, , Germany

MED Bayern OST GmbH

Burghausen, , Germany

Private Practice Lorenz

Chemnitz, , Germany

Private Practice Baerlecken

Cologne, , Germany

Private Practice Kirrstetter

Deggendorf, , Germany

Kreiskranenhaus Demmin GmbH

Demmin, , Germany

Private Practice Menne

Dortmund, , Germany

Private Practice Luethke

Dresden, , Germany

Private Practice Fischer

Dresden, , 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, , 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

Göppingen, , Germany

Private Practice Semmler

Güstrow, , Germany

private practise Kühne

Haldensleben I, , Germany

Private Practice Liebhaber

Halle, , Germany

Private Practice Dahmen

Hamburg, , Germany

private practise Aries

Hamburg, , Germany

Private Practice Stille

Hanover, , Germany

private practise Heilig

Heidelberg, , Germany

private practise Wernicke

Hohen Neuendorf, , Germany

Private Practice Kremers

Jülich, , Germany

Medius Kliniken gGmbH

Kirchheim unter Teck, , 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

Mühlhausen, , Germany

Private Practice Krueger

München, , Germany

Private Practice Raub

Münster, , Germany

Praxis Dr.med. Holger Krauel Facharzt für Innere Medizin und Rheumatologie

Naumburg, , Germany

Private Practice Berger

Naunhof, , Germany

Private Practise

Neubrandenburg, , Germany

Private Practice Volberg

Neuss, , Germany

MCN Medic Center Nuernberg GmbH

Nuremberg, , Germany

Private Practice Goettl

Passau, , Germany

Private Practice Graessler

Pirna, , Germany

Private Practice Baumann

Plauen, , Germany

Knappschaftsklinikum Soor, Klinik fuer Rheumatologie und Klinische Immunologie

Püttlingen, , 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 Moebius

Schwerin, , Germany

Private Practice

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

Tübingen, , 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 Fricke-Wagner

Zwickau, , Germany

Private Practice Alliger

Zwiesel, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=A3921302

To obtain contact information for a study center near you, click here.

Other Identifiers

ESCALATE-RA

Identifier Type: OTHER

Identifier Source: secondary_id

A3921302

Identifier Type: -

Identifier Source: org_study_id