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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Drug: Tofacitinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tofacitinib|Patients who are started on Tofacitinib treatment according to the drug label|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Impact of ΔDAS28 on the number of treatment escalations of Tofacitinib patients | Impact of ΔDAS28-4 (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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first treatment escalation | Time to first treatment escalation | 24 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |