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

Pfizer

Status

Completed

Conditions

Rheumatoid Arthritis

Study type

Observational

Funder types

Industry

Identifiers

NCT03992781

A3921330

NCT03992781 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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