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

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NCT03992781

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
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 Not yet recruiting
Estimated Enrollment
 (submitted: June 18, 2019)		154
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2022
Estimated Primary Completion Date October 31, 2022   (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 Center1-800-718-1021[email protected]
Listed Location Countries Not Provided
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2019