NCT03992781Completed
Changes of Depression After First-year of Tofacitinib in RA Patients
NON-INTERVENTIONAL STUDY TO REVIEW THE CHANGES OF DEPRESSION AFTER FIRST-YEAR OF TOFACITINIB TREATMENT IN RHEUMATOID ARTHRITIS (XELJANZ (Registered))
Source: ClinicalTrials.gov · Last updated 6 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 73 (actual)
- First submitted
- 24 May 2019
- Start date
- 23 Jul 2020
- Primary completion date
- 7 Feb 2024
- Lead sponsor
- Pfizer
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT03992781
What you commit to
- Study type: Observational
- Participants enrolled: 73
- From 23 Jul 2020 to the primary completion date, 7 Feb 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients unwilling/unable to fill in printed patient questionnaires.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rheuma s.r.o. Coordinator of this site? Confirm its status | Břeclav | Czechia | Unknown status |
| Revmatologie.s.r.o. Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Artroscan, s.r.o. Coordinator of this site? Confirm its status | Ostrava - Trebovice | Czechia | Unknown status |
| Thomayerova Nemocnice Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Revmatologicky ustav Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Revmatologicke centrum s.r.o. Coordinator of this site? Confirm its status | Velké Bílovice | Czechia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.