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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 September 2023
• Main ID: NCT03387423
• Date of registration: 07/12/2017
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis ESCALATE-RA
• Scientific 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
• Date of first enrolment: November 2, 2017
• Target sample size: 1497
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03387423
• Study type: Observational

Countries of recruitment

Germany

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Tofacitinib

Primary Outcome(s)

Impact of Patient´s Global Assessment of Arthritis on the number of treatment escalations of Tofacitinib patients [Time Frame: 24 months]

Impact of Patient´s satisfaction with drug treatment on the number of treatment escalations of Tofacitinib patients [Time Frame: 24 months]

Impact of Physician Global Assessment of Arthritis on the number of treatment escalations of Tofacitinib patients [Time Frame: 24 months]

Impact of ?DAS28 on the number of treatment escalations of Tofacitinib patients [Time Frame: 24 months]

Impact of DAS28 on the number of treatment escalations of Tofacitinib patients [Time Frame: 24 months]

Impact of Patient´s Assessment of Arthritis Pain on the number of treatment escalations of Tofacitinib patients [Time Frame: 24 months]

Secondary Outcome(s)

Drug survival at month 12 of patients on Tofacitinib [Time Frame: 12 months]

Drug survival at month 24 of patients on Tofacitinib [Time Frame: 24 months]

Change from baseline on FACIT Fatigue scale over time of patients on Tofacitinib [Time Frame: 24 months]

Patient's satisfaction with Tofacitinib treatment over time [Time Frame: 24 months]

Rate of patients with functional remission in FFbH (FFbH > 83%) over time of patients on Tofacitinib [Time Frame: 24 months]

Change from baseline in the Functional Ability Questionnaire Hannover over time of patients on Tofacitinib [Time Frame: 24 months]

Rate of Low Disease Activity over time of patients on Tofacitinib [Time Frame: 24 months]

Change from baseline of duration of morning stiffness over time of patients on Tofacitinib [Time Frame: 24 months]

Time to first treatment escalation [Time Frame: 24 months]

Change from baseline over time of patients on Tofacitinib [Time Frame: 24 months]

Change from baseline in the EuroQoL EQ-5D questionnaire over time of patients on Tofacitinib [Time Frame: 24 months]

Rate of remission over time of patients on Tofacitinib [Time Frame: 24 months]

Secondary ID(s)

A3921302

ESCALATE-RA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors