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

NCT03992781 | Completed Results

• 2 other identifiers: A3921330NCT03992781
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 6

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• CUDOS Score: Baseline (Visit 1) and 12 Months (Visit 3)

  The CUDOS questionnaire assessed the level of depression in the past week. It consisted of 18 questions. For each question the participant indicated how well it described his/her feelings during past week on the following scale: 0 = not at all true, 1 = rarely true, 2 = sometimes true, 3 = often true and 4 = almost always true. The result of this questionnaire was the sum of responses to all questions and therefore the overall possible CUDOS score ranged from 0 to 72, higher score indicated more severe depression. Absolute values of CUDOS score at baseline (Visit 1) and 12 Months (Visit 3) are reported in descriptive data below. Mean relative change was calculated by averaging the relative changes of each of the participants (sum of all relative changes divided by the number of participants) and was reported in the statistical section.

  Baseline (Visit 1), 12 Months (Visit 3)

Secondary Outcomes (11)

• CUDOS Score: Baseline (Visit 1) and 6 Months (Visit 2)

  Baseline (Visit 1), 6 Months (Visit 2)

• CUXOS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)

  Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)

• JSEQ Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)

  Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)

• VAS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)

  Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)

• Number of Participants Who Took at Least 1 Concomitant Treatment of Mental Illness Per Study Visit

  Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)

Study Arms (1)

Newly prescribed tofacitinib

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with rheumatoid arthritis who are initiated on tofacitinib as part of a usual care setting.

You may qualify if:

• 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.

You may not qualify if:

• Patients unwilling/unable to fill in printed patient questionnaires.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (6)

Thomayerova nemocnice

Prague, Czech Republic, 140 59, Czechia

Location

Revmatologie s.r.o.

Brno, 63800, Czechia

Location

Rheuma s.r.o.

Břeclav, Czechia

Location

Artroscan, s.r.o.

Ostrava - Trebovice, Czechia

Location

Revmatologicky ustav

Prague, 12800, Czechia

Location

Revmatologicke centrum s.r.o.

Velké Bílovice, 69102, Czechia

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: June 20, 2019
• Study Start: July 23, 2020
• Primary Completion: February 7, 2024
• Study Completion: February 7, 2024
• Last Updated: April 6, 2025
• Results First Posted: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (6)