We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03992781
Recruitment Status : Active, not recruiting
First Posted : June 20, 2019
Last Update Posted : May 18, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 73 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 : January 22, 2024
Estimated Study Completion Date : January 22, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Newly prescribed tofacitinib
patients who were newly prescribed tofacitinib at baseline and who scored at least 11 points on CUDOS scale


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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).
  • Capable of understanding and signing a written informed consent form.
  • 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:

  • Patients unwilling/unable to fill in printed patient questionnaires.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992781


Locations
Layout table for location information
Czechia
Thomayerova nemocnice
Prague, Czech Republic, Czechia, 140 59
Rheuma s.r.o.
Breclav, Czechia
Revmatologie s.r.o.
Brno, Czechia, 63800
Mangala Hospital & Mangala Kidney Foundation
Karlovy Vary, Czechia
Artroscan, s.r.o.
Ostrava - Trebovice, Czechia
Revmatologicky ustav
Praha 2, Czechia, 12800
Revmatologicka ambulance
Sumperk, Czechia
Revmatologicke centrum s.r.o.
Velke Bilovice, Czechia, 69102
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03992781    
Other Study ID Numbers: A3921330
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: May 18, 2023
Last Verified: May 2023
Individual Participant Data (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.
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases