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

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ClinicalTrials.gov Identifier: NCT03992781
Recruitment Status : Recruiting
First Posted : June 20, 2019
Last Update Posted : October 11, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

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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 : January 22, 2024
Estimated Study Completion Date : January 22, 2024

Resource links provided by the National Library of Medicine


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



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) ]


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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).
  • 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.

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


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
Mangala Hospital & Mangala Kidney Foundation Not yet recruiting
Karlovy Vary, Czechia
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
Revmatologicka ambulance Not yet recruiting
Sumperk, Czechia
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
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03992781    
Other Study ID Numbers: A3921330
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: October 11, 2021
Last Verified: October 2021
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:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases