Clinical trial NCT03387423: Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-01-02
Enrollment: 1459
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with confirmed diagnosis of rheumatoid arthritis who are eligible for treatment with Tofacitinb according to Summary of Product Characteristics (SmPC)

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.


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.

Primary outcomes:
measure: Number of Participants With Treatment Escalations
timeFrame: From date of first prescription of tofacitinib up to 24 Months
measure: Time to Treatment Escalation
timeFrame: From date of first prescription of tofacitinib up to 24 Months
Secondary outcomes:
measure: Time to First Step Up Treatment Escalation
timeFrame: From date of first tofacitinib prescription up to date of first step-up treatment escalation (maximum up to 24 months)
measure: 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
timeFrame: Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: 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
timeFrame: Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: 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
timeFrame: Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Mean Number of Days of Drug Survival at Months 12 and 24
timeFrame: At 12 and 24 months
measure: Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Private Praxis
state: Nordrhein-westfalen
city: Zschopau
country: Germany
facility: Private Practice
state: Sachsen
city: Altenburg
country: Germany
facility: Private Practice Kupka
city: Altenholz
country: Germany
facility: Private Practise Boehm
city: Amberg
country: Germany
facility: Private Practice Marycz
city: Augsburg
country: Germany
facility: Private Practice Fuchs
city: Bad Bramstedt
country: Germany
facility: private practise Gause
city: Bad Kreuznach
country: Germany
facility: ACURA Kliniken Rheinland-Pfalz AG
city: Bad Pyrmont
country: Germany
facility: MFZ Medizinisches Forschungszentrum Weserbergland
city: Bamberg
country: Germany
facility: Private Practice Manger
city: Bayreuth
country: Germany
facility: Private Practice Ochs
city: Bayreuth
country: Germany
facility: Private Practice Schmitt-Haendle
city: Bayreuth
country: Germany
facility: Private Practice
city: Berlin
country: Germany
facility: Ambulantes Gesundheitszentrum der Charité
city: Berlin
country: Germany
facility: Private Practice Bozorg
city: Berlin
country: Germany
facility: Private Practice Brandt-Juergens
city: Berlin
country: Germany
facility: Privat Practice Remstedt
city: Berlin
country: Germany
facility: private practise Herzberg
city: Berlin
country: Germany
facility: Private Practice Seifert
city: Berlin
country: Germany
facility: Private Practice Zinke
city: Berlin
country: Germany
facility: Private Practice Thiele
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau
city: Braunschweig
country: Germany
facility: Private Practise
city: Burghausen
country: Germany
facility: MED Bayern OST GmbH
city: Chemnitz
country: Germany
facility: Private Practice Lorenz
city: Deggendorf
country: Germany
facility: Private Practice Kirrstetter
city: Demmin
country: Germany
facility: Kreiskranenhaus Demmin GmbH
city: Dortmund
country: Germany
facility: Private Practice Menne
city: Dresden
country: Germany
facility: Private Practice Luethke
city: Dresden
country: Germany
facility: Private Practice Fischer
city: Eberswalde
country: Germany
facility: private practise Pech
city: Ehringshausen
country: Germany
facility: Private Practice Steinmueller
city: Elmshorn
country: Germany
facility: Asklepios MVZ Nord SH GmbH, c/o AK St. Georg
city: Erfurt
country: Germany
facility: Private Practice Kaestner
city: Erfurt
country: Germany
facility: Private Practice Koch
city: Frankenberg/Sa.
country: Germany
facility: Private Practice Haeckel
city: Freiberg
country: Germany
facility: Private Practice Mueller
city: Friedrichroda
country: Germany
facility: SRH Krankenhaus Waltershausen-Friedrichroda GmbH
city: Germering
country: Germany
facility: Private Practice Abahji
city: Gifhorn
country: Germany
facility: Private Practice Sensse
city: Glaisin
country: Germany
facility: Private Practice Holst
city: Goeppingen
country: Germany
facility: Private Practice Zeh
city: Guestrow
country: Germany
facility: Private Practice Semmler
city: Haldensleben
country: Germany
facility: private practise Kühne
city: Halle
country: Germany
facility: Private Practice Liebhaber
city: Hamburg
country: Germany
facility: Private Practice Dahmen
city: Hamburg
country: Germany
facility: private practise Aries
city: Hannover
country: Germany
facility: Private Practice Stille
city: Heidelberg
country: Germany
facility: private practise Heilig
city: Hohen Neuendorf
country: Germany
facility: private practise Wernicke
city: Juelich
country: Germany
facility: Private Practice Kremers
city: Kirchheim unter Teck
country: Germany
facility: Medius Kliniken gGmbH
city: Koeln
country: Germany
facility: Private Practice Baerlecken
city: Langenau
country: Germany
facility: Kreiskrankenhaus Langenau
city: Leipzig
country: Germany
facility: Private Practice Hamann
city: Leipzig
country: Germany
facility: Private Practice Schwarze
city: Magdeburg
country: Germany
facility: Private Practice Kudela
city: Magdeburg
country: Germany
facility: private practise Sieburg
city: Mansfeld
country: Germany
facility: Private Practice Rossbach
city: Marktredwitz
country: Germany
facility: Private Practice Harmuth
city: Muehlhausen
country: Germany
facility: Private Practice Worsch
city: Muenchen
country: Germany
facility: Private Practice Krueger
city: Muenster
country: Germany
facility: Private Practice Raub
city: Naumburg (Saale)
country: Germany
facility: Praxis Dr.med. Holger Krauel Facharzt für Innere Medizin und Rheumatologie
city: Naunhof
country: Germany
facility: Private Practice Berger
city: Neubrandenburg
country: Germany
facility: Private Practise
city: Neuss
country: Germany
facility: Private Practice Volberg
city: Nuernberg
country: Germany
facility: MCN Medic Center Nuernberg GmbH
city: Passau
country: Germany
facility: Private Practice Goettl
city: Pirna
country: Germany
facility: Private Practice Graessler
city: Plauen
country: Germany
facility: Private Practice Baumann
city: Puettlingen
country: Germany
facility: Knappschaftsklinikum Soor, Klinik fuer Rheumatologie und Klinische Immunologie
city: Ratingen
country: Germany
facility: Private Practice Wassenberg, Koehler, Weier
city: Rostock
country: Germany
facility: Private Practice Richter
city: Saarbrücken
country: Germany
facility: private practise Biewer
city: Schweinfurt
country: Germany
facility: MVZ Dialysezentrum Schweinfurt
city: Schwerin
country: Germany
facility: Private Practice Moebius
city: Schwerin
country: Germany
facility: Private Practice
city: Schwerin
country: Germany
facility: private practise Ständer
city: Seesen
country: Germany
facility: Private Practice Melzer
city: Straubing
country: Germany
facility: MVZ Klinikum Straubing
city: Templin
country: Germany
facility: Private Practice
city: Torgelow
country: Germany
facility: Private Practice Pyra
city: Tuebingen
country: Germany
facility: Private Practice Haas
city: Uhlstaedt-Kirchhasel
country: Germany
facility: Klinik an der Weissenburg GmbH
city: Ulm
country: Germany
facility: Private Practice Rinaldi
city: Wiesbaden
country: Germany
facility: Private Practice Woerth
city: Wuppertal
country: Germany
facility: Klinikverbund St. Antonius und St. Josef GmbH
city: Wuppertal
country: Germany
facility: Rheuma Praxis Barmen Dres. med. Demirel / Hruschka
city: Zwickau
country: Germany
facility: Private Practice Fricke-Wagner
city: Zwiesel
country: Germany
facility: Private Practice Alliger
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: