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Trial record 1 of 1 for:    NCT03387423
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Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis (ESCALATE-RA)

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ClinicalTrials.gov Identifier: NCT03387423
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date December 7, 2017
First Posted Date January 2, 2018
Last Update Posted Date June 4, 2019
Actual Study Start Date November 2, 2017
Estimated Primary Completion Date February 11, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2017)
  • Impact of DAS28 on the number of treatment escalations of Tofacitinib patients [ Time Frame: 24 months ]
    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.
  • Impact of ΔDAS28 on the number of treatment escalations of Tofacitinib patients [ Time Frame: 24 months ]
    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.
  • Impact of Physician Global Assessment of Arthritis 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 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.
  • Impact of Patient´s Assessment of Arthritis Pain 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 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.
  • Impact of Patient´s satisfaction with drug treatment 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 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.
  • 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 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03387423 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 21, 2017)
  • Time to first treatment escalation [ Time Frame: 24 months ]
    Time to first treatment escalation
  • Rate of Low Disease Activity over time of patients on Tofacitinib [ Time Frame: 24 months ]
    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.
  • Rate of remission over time of patients on Tofacitinib [ Time Frame: 24 months ]
    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.
  • Change from baseline over time of patients on Tofacitinib [ Time Frame: 24 months ]
    Change from baseline over time of patients on Tofacitinib (in combination therapy or monotherapy) in DAS 28-4 (ESR) and DAS 28-4 (CRP)
  • Change from baseline of duration of morning stiffness over time of patients on Tofacitinib [ Time Frame: 24 months ]
    Change from baseline of duration of morning stiffness over time of patients on Tofacitinib (in combination therapy or monotherapy)
  • Change from baseline in the Functional Ability Questionnaire Hannover over time of patients on Tofacitinib [ Time Frame: 24 months ]
    Change from baseline in the Functional Ability Questionnaire Hannover (FFbH) over time of patients on Tofacitinib (in combination therapy or monotherapy)
  • Rate of patients with functional remission in FFbH (FFbH > 83%) over time of patients on Tofacitinib [ Time Frame: 24 months ]
    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 %.
  • Change from baseline in the EuroQoL EQ-5D questionnaire over time of patients on Tofacitinib [ Time Frame: 24 months ]
    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)
  • Change from baseline on FACIT Fatigue scale over time of patients on Tofacitinib [ Time Frame: 24 months ]
    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).
  • Drug survival at month 12 of patients on Tofacitinib [ Time Frame: 12 months ]
    Drug survival at month 12 of patients on Tofacitinib (in combination therapy or monotherapy)
  • Drug survival at month 24 of patients on Tofacitinib [ Time Frame: 24 months ]
    Drug survival at month 24 of patients on Tofacitinib (in combination therapy or monotherapy)
  • Patient's satisfaction with Tofacitinib treatment over time [ Time Frame: 24 months ]
    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?".
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
 (submitted: December 21, 2017)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 11, 2023
Estimated Primary Completion Date February 11, 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
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2019