Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis
ESCALATE-RA
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
2 other identifiers
observational
1,459
1 country
91
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Longer than P75 for all trials
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 2, 2017
CompletedFirst Submitted
Initial submission to the registry
December 7, 2017
CompletedFirst Posted
Study publicly available on registry
January 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2023
CompletedResults Posted
Study results publicly available
October 21, 2024
CompletedOctober 21, 2024
July 1, 2024
5.7 years
December 7, 2017
July 12, 2024
July 12, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Treatment Escalations
Treatment escalations was defined as participants who switched to another disease modifying antirheumatic drug (DMARD) or combination of DMARDs when compared to the last visit. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime towards e.g.a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, example (e.g.) from combination therapy to monotherapy. One participant can fall into more than 1 type of escalation.
From date of first prescription of tofacitinib up to 24 Months
Time to Treatment Escalation
Time to treatment escalation was defined as time in days from escalation visit date to next escalation visit date. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, e.g. from combination therapy to monotherapy. Number of participants with total number of each type of treatment escalations during the study (step-up/switch, step-down, treatment termination along with all escalations) are reported in this outcome measure.
From date of first prescription of tofacitinib up to 24 Months
Secondary Outcomes (19)
Time to First Step Up Treatment Escalation
From date of first tofacitinib prescription up to date of first step-up treatment escalation (maximum up to 24 months)
Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24
Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24
Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24
Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24
Months 3, 6, 9, 12, 15, 18, 21 and 24
- +14 more secondary outcomes
Interventions
Patients who are started on Tofacitinib treatment according to the drug label
Eligibility Criteria
Adult patients with confirmed diagnosis of rheumatoid arthritis who are eligible for treatment with Tofacitinb according to Summary of Product Characteristics (SmPC)
You may qualify if:
- 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.
You may not qualify if:
- Contraindications according to Xeljanz® SmPC
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (91)
Private Praxis
Düsseldorf, North Rhine-Westphalia, 40237, Germany
Private Practice
Zschopau, Saxony, 09405, Germany
Private Practice Kupka
Altenburg, 04600, Germany
Private Practise Boehm
Altenholz, 24161, Germany
Private Practice Marycz
Amberg, 92224, Germany
Private Practice Fuchs
Augsburg, 86157, Germany
private practise Gause
Bad Bramstedt, 24576, Germany
ACURA Kliniken Rheinland-Pfalz AG
Bad Kreuznach, 55543, Germany
MFZ Medizinisches Forschungszentrum Weserbergland
Bad Pyrmont, 31812, Germany
Private Practice Manger
Bamberg, 96047, Germany
Private Practice Ochs
Bayreuth, 95444, Germany
Private Practice Schmitt-Haendle
Bayreuth, 95444, Germany
Private Practice
Bayreuth, 95444, Germany
Ambulantes Gesundheitszentrum der Charité
Berlin, 10117, Germany
Private Practice Bozorg
Berlin, 10713, Germany
Private Practice Brandt-Juergens
Berlin, 12161, Germany
Privat Practice Remstedt
Berlin, 12435, Germany
private practise Herzberg
Berlin, 12435, Germany
Private Practice Seifert
Berlin, 12555, Germany
Private Practice Zinke
Berlin, 13055, Germany
Private Practice Thiele
Berlin, 14129, Germany
Immanuel Klinikum Bernau
Bernau, 16321, Germany
Private Practise
Braunschweig, 38100, Germany
MED Bayern OST GmbH
Burghausen, 84489, Germany
Private Practice Lorenz
Chemnitz, 09139, Germany
Private Practice Baerlecken
Cologne, 50996, Germany
Private Practice Kirrstetter
Deggendorf, 94469, Germany
Kreiskranenhaus Demmin GmbH
Demmin, 17109, Germany
Private Practice Menne
Dortmund, 44263, Germany
Private Practice Luethke
Dresden, 01097, Germany
Private Practice Fischer
Dresden, 01277, Germany
private practise Pech
Eberswalde, 16225, Germany
Private Practice Steinmueller
Ehringshausen, 35630, Germany
Asklepios MVZ Nord SH GmbH, c/o AK St. Georg
Elmshorn, 25335, Germany
Private Practice Kaestner
Erfurt, 99096, Germany
Private Practice Koch
Erfurt, 99096, Germany
Private Practice Haeckel
Frankenberg, 09669, Germany
Private Practice Mueller
Freiberg, 09599, Germany
SRH Krankenhaus Waltershausen-Friedrichroda GmbH
Friedrichroda, 99894, Germany
Private Practice Abahji
Germering, 82110, Germany
Private Practice Sensse
Gifhorn, 38518, Germany
Private Practice Holst
Glaisin, 19288, Germany
Private Practice Zeh
Göppingen, 73033, Germany
Private Practice Semmler
Güstrow, 18273, Germany
private practise Kühne
Haldensleben I, 39340, Germany
Private Practice Liebhaber
Halle, 06128, Germany
Private Practice Dahmen
Hamburg, 22415, Germany
private practise Aries
Hamburg, 22767, Germany
Private Practice Stille
Hanover, 30161, Germany
private practise Heilig
Heidelberg, 69120, Germany
private practise Wernicke
Hohen Neuendorf, 16540, Germany
Private Practice Kremers
Jülich, 52428, Germany
Medius Kliniken gGmbH
Kirchheim unter Teck, 73230, Germany
Kreiskrankenhaus Langenau
Langenau, 89129, Germany
Private Practice Hamann
Leipzig, 04109, Germany
Private Practice Schwarze
Leipzig, 04129, Germany
Private Practice Kudela
Magdeburg, 39104, Germany
private practise Sieburg
Magdeburg, 39104, Germany
Private Practice Rossbach
Mansfeld, 06343, Germany
Private Practice Harmuth
Marktredwitz, 95615, Germany
Private Practice Worsch
Mühlhausen, 99974, Germany
Private Practice Krueger
München, 81541, Germany
Private Practice Raub
Münster, 48143, Germany
Praxis Dr.med. Holger Krauel Facharzt für Innere Medizin und Rheumatologie
Naumburg, 06618, Germany
Private Practice Berger
Naunhof, 04683, Germany
Private Practise
Neubrandenburg, 17033, Germany
Private Practice Volberg
Neuss, 41462, Germany
MCN Medic Center Nuernberg GmbH
Nuremberg, 90443, Germany
Private Practice Goettl
Passau, 94032, Germany
Private Practice Graessler
Pirna, 01796, Germany
Private Practice Baumann
Plauen, 08523, Germany
Knappschaftsklinikum Soor, Klinik fuer Rheumatologie und Klinische Immunologie
Püttlingen, 66346, Germany
Private Practice Wassenberg, Koehler, Weier
Ratingen, 40878, Germany
Private Practice Richter
Rostock, 18059, Germany
private practise Biewer
Saarbrücken, 66111, Germany
MVZ Dialysezentrum Schweinfurt
Schweinfurt, 97421, Germany
Private Practice Moebius
Schwerin, 19053, Germany
Private Practice
Schwerin, 19053, Germany
private practise Ständer
Schwerin, 19053, Germany
Private Practice Melzer
Seesen, 38723, Germany
MVZ Klinikum Straubing
Straubing, 94315, Germany
Private Practice
Templin, 17268, Germany
Private Practice Pyra
Torgelow, 17358, Germany
Private Practice Haas
Tübingen, 72072, Germany
Klinik an der Weissenburg GmbH
Uhlstaedt-Kirchhasel, 07407, Germany
Private Practice Rinaldi
Ulm, 89073, Germany
Private Practice Woerth
Wiesbaden, 65189, Germany
Klinikverbund St. Antonius und St. Josef GmbH
Wuppertal, 42105, Germany
Rheuma Praxis Barmen Dres. med. Demirel / Hruschka
Wuppertal, 42285, Germany
Private Practice Fricke-Wagner
Zwickau, 08056, Germany
Private Practice Alliger
Zwiesel, 94227, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2017
First Posted
January 2, 2018
Study Start
November 2, 2017
Primary Completion
July 17, 2023
Study Completion
July 17, 2023
Last Updated
October 21, 2024
Results First Posted
October 21, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.