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出境医 / 临床实验 / Changes of Depression After First-year of Tofacitinib in RA Patients

Changes of Depression After First-year of Tofacitinib in RA Patients

Study Description
Brief Summary:
12-month, single arm, prospective, non-interventional, multi-center study according to Czech legal definitions (Law 378/2007 Sb.).The primary objective of this study is to describe and evaluate the changes of depression level within 12 months from the start of tofacitinib therapy in patients with RA and at least minimal level of depression. Primary goal is to find out if treatment by tofacitinib reduces the depression by at least 10% during 12 months.

Condition or disease
Rheumatoid Arthritis

Study Design
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Study Type : Observational
Estimated Enrollment : 154 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NON-INTERVENTIONAL STUDY TO REVIEW THE CHANGES OF DEPRESSION AFTER FIRST-YEAR OF TOFACITINIB TREATMENT IN RHEUMATOID ARTHRITIS (XELJANZ (Registered))
Actual Study Start Date : July 23, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Change in Patient Self Assessment of Clinically Useful Depression Outcome Scale (CUDOS) [ Time Frame: Baseline, Visit 3 (12 months after start of Tofacitinib treatment) ]

Secondary Outcome Measures :
  1. Baseline value and relative change between visit 2 and baseline of CUDOS score [ Time Frame: Baseline, Visit 2 (6 months after start of Tofacitinib treatment) ]
  2. Changes in Clinically Useful Anxiety Outcome Scale (CUXOS) for evaluation of anxiety [ Time Frame: Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment) ]
  3. Changes in Jenkins Sleep Evaluation Questionnaire (JSEQ) for evaluation of insomnia [ Time Frame: Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment) ]
  4. Changes in Visual Analog Scale (VAS) score for evaluation of arthritis pain [ Time Frame: Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment) ]
  5. Counts of concomitant medication (antidepressants, analgesics, anxiolytics and hypnotics) together with doses for each and the change in number of used medicaments and in their dosage [ Time Frame: Baseline, Visit 3 (12 months after start of Tofacitinib treatment) ]
  6. Absolute change of DAS28 4 (Erythrocyte sedimentation rate (ESR)) [ Time Frame: Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment) ]
  7. Absolute change of DAS28 4 (C reactive protein (CRP)) [ Time Frame: Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with rheumatoid arthritis who are initiated on tofacitinib as part of a usual care setting.
Criteria

Inclusion Criteria:

  • Patients aged ≥18 years.
  • Moderate to severe activity of rheumatoid arthritis (DAS28 ≥3.2).
  • Patient for whom the physician decision has been made to initiate a treatment with Tofacitinib.
  • Patient with at least minimal level of depression (CUDOS questionnaire ≥11 points).
  • Patient who have been prescribed Tofacitinib treatment according to SmPC and SUKL's criteria for reimbursement.
  • 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 is a requirement for inclusion into this study.

Exclusion Criteria:

  • Contraindications according to Xeljanz® SmPC
  • Receipt of any investigational drug within 3 months before study inclusion.
  • Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the trial.
Contacts and Locations

Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Czechia
Thomayerova nemocnice Recruiting
Prague, Czech Republic, Czechia, 140 59
Rheuma s.r.o. Recruiting
Breclav, Czechia
Revmatologie s.r.o. Recruiting
Brno, Czechia, 63800
Revmatologie MUDr. Sirova s.r.o. Not yet recruiting
Ostrava - Moravska Ostrava, Czechia, 702 00
Artroscan, s.r.o. Recruiting
Ostrava - Trebovice, Czechia
Revmatologicky ustav Recruiting
Praha 2, Czechia, 12800
Medical Plus s.r.o. Not yet recruiting
Uherske Hradiste, Czechia, 68601
Revmatologicke centrum s.r.o. Recruiting
Velke Bilovice, Czechia, 69102
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Tracking Information
First Submitted Date May 24, 2019
First Posted Date June 20, 2019
Last Update Posted Date May 24, 2021
Actual Study Start Date July 23, 2020
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2019) 		Change in Patient Self Assessment of Clinically Useful Depression Outcome Scale (CUDOS) [ Time Frame: Baseline, Visit 3 (12 months after start of Tofacitinib treatment) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 18, 2019)
  • Baseline value and relative change between visit 2 and baseline of CUDOS score [ Time Frame: Baseline, Visit 2 (6 months after start of Tofacitinib treatment) ]
  • Changes in Clinically Useful Anxiety Outcome Scale (CUXOS) for evaluation of anxiety [ Time Frame: Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment) ]
  • Changes in Jenkins Sleep Evaluation Questionnaire (JSEQ) for evaluation of insomnia [ Time Frame: Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment) ]
  • Changes in Visual Analog Scale (VAS) score for evaluation of arthritis pain [ Time Frame: Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment) ]
  • Counts of concomitant medication (antidepressants, analgesics, anxiolytics and hypnotics) together with doses for each and the change in number of used medicaments and in their dosage [ Time Frame: Baseline, Visit 3 (12 months after start of Tofacitinib treatment) ]
  • Absolute change of DAS28 4 (Erythrocyte sedimentation rate (ESR)) [ Time Frame: Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment) ]
  • Absolute change of DAS28 4 (C reactive protein (CRP)) [ Time Frame: Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment) ]
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 Changes of Depression After First-year of Tofacitinib in RA Patients
Official Title NON-INTERVENTIONAL STUDY TO REVIEW THE CHANGES OF DEPRESSION AFTER FIRST-YEAR OF TOFACITINIB TREATMENT IN RHEUMATOID ARTHRITIS (XELJANZ (Registered))
Brief Summary 12-month, single arm, prospective, non-interventional, multi-center study according to Czech legal definitions (Law 378/2007 Sb.).The primary objective of this study is to describe and evaluate the changes of depression level within 12 months from the start of tofacitinib therapy in patients with RA and at least minimal level of depression. Primary goal is to find out if treatment by tofacitinib reduces the depression by at least 10% during 12 months.
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 Probability Sample
Study Population Patients with rheumatoid arthritis who are initiated on tofacitinib as part of a usual care setting.
Condition Rheumatoid Arthritis
Intervention Not Provided
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: June 18, 2019) 		154
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2023
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients aged ≥18 years.
  • Moderate to severe activity of rheumatoid arthritis (DAS28 ≥3.2).
  • Patient for whom the physician decision has been made to initiate a treatment with Tofacitinib.
  • Patient with at least minimal level of depression (CUDOS questionnaire ≥11 points).
  • Patient who have been prescribed Tofacitinib treatment according to SmPC and SUKL's criteria for reimbursement.
  • 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 is a requirement for inclusion into this study.

Exclusion Criteria:

  • Contraindications according to Xeljanz® SmPC
  • Receipt of any investigational drug within 3 months before study inclusion.
  • Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the trial.
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 Czechia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03992781
Other Study ID Numbers A3921330
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 May 2021

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