Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis
NCT03387423
ABOUT THIS STUDY
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Adult Trials: 18+ Years
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.
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | 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 | ||||
| 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 Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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) | ||||
| Condition | Arthritis, Rheumatoid | ||||
| Intervention | Drug: Tofacitinib
Patients who are started on Tofacitinib treatment according to the drug label | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment | 1500 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | July 23, 2023 | ||||
| Estimated Primary Completion Date | July 23, 2023 (Final data collection date for primary outcome measure) | ||||
| 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. | ||||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | Germany | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03387423 | ||||
| Other Study ID Numbers | A3921302 ESCALATE-RA ( Other Identifier: Alias Study Number ) | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
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| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Pfizer | ||||
| Verification Date | April 2021 | ||||