Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis
- Conditions
- Arthritis, Rheumatoid
- Registration Number
- NCT03387423
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1459
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Escalations From date of first prescription of tofacitinib up to 24 Months 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.
Time to Treatment Escalation From date of first prescription of tofacitinib up to 24 Months 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.
- Secondary Outcome Measures
Name Time Method 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) Time to first step-up treatment escalation was defined for participants who experienced a treatment step-up and was measured as date of first treatment step up escalation minus (-) date of first prescription of tofacitinib. Treatment step-up was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs.
Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56\*square root of (TJC28) + 0.28\*square root of (SJC28) + 0.70\*In (ESR in mm/ hour) + 0.014\*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.
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 SDAI was calculated using the following formula: SDAI = Tender Joint Count (TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 centimetre \[cm\] scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + C-reactive protein (CRP) (milligram per decilitre \[mg/dL\]). TJC28 joints included shoulders, elbows, wrists, metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm visual analogue scale (VAS) scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of less than or equal to (\<=11) indicates LDA.
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 CDAI was calculated using the following formula: CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm). TJC28 joints included shoulders, elbows, wrists, MCP and proximal PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<= 10 indicates LDA.
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 DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56\* square root of (TJC28) + 0.28\* square root of (SJC28) + 0.70\* natural log (ln) (ESR in \[millimeter per hour \[mm/ hour\]) + 0.014\*(PtGA in cm). PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR \<= 3.2 indicates LDA.
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 DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56\* square root of (TJC28) + 0.28\* square root of (SJC28) + 0.36\*ln (CRP in mg/l +1) + 0.014\*(PtGA in mm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP \<= 3.2 indicates LDA.
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 Months 3, 6, 9, 12, 15, 18, 21 and 24 ACR-EULAR Boolean remission criteria was defined as when participant had ACR remission =1 if; TJC28 \<=1, SJC28 \<=1, CRP \<=1mg/dL and PtGA \<= 2 cm on a 0 to 10 cm scale, where higher values indicate greater affection due to disease activity.
Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Months 3, 6, 9, 12, 15, 18, 21 and 24 SDAI was calculated using the following formula: SDAI = (TJC28) + (SJC28) + (PtGA in cm) + (PhGA in cm) + (CRP in mg/dL). TJC28 joints included shoulders, elbows, wrists, MCP and PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of \<=3.3 indicates remission.
Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Months 3, 6, 9, 12, 15, 18, 21 and 24 CDAI was calculated using the following formula: CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm). TJC28 joints included shoulders, elbows, wrists, MCP and proximal PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<=2.8 indicates remission.
Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Months 3, 6, 9, 12, 15, 18, 21 and 24 DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56\*square root of (TJC28) + 0.28\*square root of (SJC28) + 0.70\*In (ESR in mm/ hour) + 0.014\*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR score of \<2.6 indicates remission.
Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Months 3, 6, 9, 12, 15, 18, 21 and 24 DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56\*square root of (TJC28) + 0.28\*square root of (SJC28) + 0.36\*ln (CRP in mg/l +1) + 0.014\*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP score of \<2.6 indicates remission.
Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56\*square root of(TJC28) + 0.28\*square root of(SJC28) + 0.36\*ln (CRP in mg/l +1) + 0.014\*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.
Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24 Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 The duration of morning stiffness was determined by asking the following questions: "When you wake up in the morning, do you currently suffer from morning stiffness?" "How long does the morning stiffness last from the time you wake up?". The change from baseline in duration of morning stiffness was calculated as: morning stiffness at time point -morning stiffness at baseline.
Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 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, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points).The functional capacity (%) is calculated by (total score\*100) divided by (2\*number of valid responses). The change from baseline was calculated at each time point as functional capacity at timepoint - functional capacity at baseline.
Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24 Months 3, 6, 9, 12, 15, 18, 21 and 24 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, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points). The functional capacity \[%\] is calculated by (total score\*100)/ (2\*number of valid responses). Functional remission in FFbH was defined as functional capacity \> 83 %.
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 Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 The EQ-5D-3L is a standardised instrument used to measure quality of life. It is based on five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group (German weights) assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24 Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).
Mean Number of Days of Drug Survival at Months 12 and 24 At 12 and 24 months Drug survival was assessed using Kaplan-Meier methodology. For participants who terminated tofacitinib, the drug survival status was recorded as (status = 1 and time = termination date tofacitinib - date of initiation on tofacitinib) and for participants who do not terminate tofacitinib (status = 0 and time = date of final visit - date of initiation on tofacitinib.
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Months 3, 6, 9, 12, 15, 18, 21 and 24 Satisfaction with treatment was 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?".
Trial Locations
- Locations (87)
Private Practice Richter
🇩🇪Rostock, Germany
Private Practice
🇩🇪Templin, Germany
Private Praxis
🇩🇪Duesseldorf, Nordrhein-westfalen, Germany
Private Practice Kupka
🇩🇪Altenburg, Germany
Private Practise Boehm
🇩🇪Altenholz, Germany
Private Practice Marycz
🇩🇪Amberg, Germany
Private Practice Manger
🇩🇪Bamberg, Germany
MFZ Medizinisches Forschungszentrum Weserbergland
🇩🇪Bad Pyrmont, Germany
Private Practice Ochs
🇩🇪Bayreuth, Germany
Private Practice Schmitt-Haendle
🇩🇪Bayreuth, Germany
Private Practice Bozorg
🇩🇪Berlin, Germany
Private Practice Brandt-Juergens
🇩🇪Berlin, Germany
Privat Practice Remstedt
🇩🇪Berlin, Germany
Private Practice Zinke
🇩🇪Berlin, Germany
private practise Herzberg
🇩🇪Berlin, Germany
Private Practice Seifert
🇩🇪Berlin, Germany
Private Practice Thiele
🇩🇪Berlin, Germany
Private Practise
🇩🇪Neubrandenburg, Germany
Immanuel Klinikum Bernau
🇩🇪Bernau, Germany
Private Practice Lorenz
🇩🇪Chemnitz, Germany
Kreiskranenhaus Demmin GmbH
🇩🇪Demmin, Germany
Private Practice Steinmueller
🇩🇪Ehringshausen, Germany
Private Practice Kaestner
🇩🇪Erfurt, Germany
Private Practice Koch
🇩🇪Erfurt, Germany
Private Practice Mueller
🇩🇪Freiberg, Germany
Private Practice Haeckel
🇩🇪Frankenberg/Sa., Germany
Private Practice Abahji
🇩🇪Germering, Germany
Private Practice Sensse
🇩🇪Gifhorn, Germany
private practise Kühne
🇩🇪Haldensleben, Germany
Private Practice Semmler
🇩🇪Guestrow, Germany
Private Practice Dahmen
🇩🇪Hamburg, Germany
Private Practice Liebhaber
🇩🇪Halle, Germany
private practise Aries
🇩🇪Hamburg, Germany
private practise Heilig
🇩🇪Heidelberg, Germany
Medius Kliniken gGmbH
🇩🇪Kirchheim unter Teck, Germany
Kreiskrankenhaus Langenau
🇩🇪Langenau, Germany
Private Practice Kudela
🇩🇪Magdeburg, Germany
Private Practice Hamann
🇩🇪Leipzig, Germany
private practise Sieburg
🇩🇪Magdeburg, Germany
Private Practice Schwarze
🇩🇪Leipzig, Germany
Private Practice Rossbach
🇩🇪Mansfeld, Germany
Private Practice Harmuth
🇩🇪Marktredwitz, Germany
Private Practice Worsch
🇩🇪Muehlhausen, Germany
Private Practice Raub
🇩🇪Muenster, Germany
Private Practice Berger
🇩🇪Naunhof, Germany
Private Practice Krueger
🇩🇪Muenchen, Germany
Praxis Dr.med. Holger Krauel Facharzt für Innere Medizin und Rheumatologie
🇩🇪Naumburg (Saale), Germany
Private Practice Volberg
🇩🇪Neuss, Germany
MVZ Dialysezentrum Schweinfurt
🇩🇪Schweinfurt, Germany
MVZ Klinikum Straubing
🇩🇪Straubing, Germany
Private Practice Melzer
🇩🇪Seesen, Germany
Private Practice Alliger
🇩🇪Zwiesel, Germany
MED Bayern OST GmbH
🇩🇪Burghausen, Germany
Private Practice Fuchs
🇩🇪Augsburg, Germany
private practise Gause
🇩🇪Bad Bramstedt, Germany
Private Practice Menne
🇩🇪Dortmund, Germany
ACURA Kliniken Rheinland-Pfalz AG
🇩🇪Bad Kreuznach, Germany
Ambulantes Gesundheitszentrum der Charité
🇩🇪Berlin, Germany
Private Practice Kirrstetter
🇩🇪Deggendorf, Germany
Private Practice Fischer
🇩🇪Dresden, Germany
private practise Pech
🇩🇪Eberswalde, Germany
Private Practice Luethke
🇩🇪Dresden, Germany
SRH Krankenhaus Waltershausen-Friedrichroda GmbH
🇩🇪Friedrichroda, Germany
Private Practice Holst
🇩🇪Glaisin, Germany
Private Practice Zeh
🇩🇪Goeppingen, Germany
Asklepios MVZ Nord SH GmbH, c/o AK St. Georg
🇩🇪Elmshorn, Germany
Private Practice Kremers
🇩🇪Juelich, Germany
private practise Wernicke
🇩🇪Hohen Neuendorf, Germany
Private Practice Stille
🇩🇪Hannover, Germany
Private Practice Baerlecken
🇩🇪Koeln, Germany
MCN Medic Center Nuernberg GmbH
🇩🇪Nuernberg, Germany
Private Practice Goettl
🇩🇪Passau, Germany
Private Practice Wassenberg, Koehler, Weier
🇩🇪Ratingen, Germany
Private Practice Baumann
🇩🇪Plauen, Germany
Private Practice Graessler
🇩🇪Pirna, Germany
private practise Biewer
🇩🇪Saarbrücken, Germany
Knappschaftsklinikum Soor, Klinik fuer Rheumatologie und Klinische Immunologie
🇩🇪Puettlingen, Germany
Private Practice Pyra
🇩🇪Torgelow, Germany
Private Practice Moebius
🇩🇪Schwerin, Germany
Private Practice Haas
🇩🇪Tuebingen, Germany
private practise Ständer
🇩🇪Schwerin, 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