N/A
Completed N=73
Changes of Depression After First-year of Tofacitinib in RA Patients
Source: ClinicalTrials.gov NCT03992781 ↗Enrolled (actual)
73
Serious AEs
1.4%
Results posted
Apr 2025
Primary outcomePrimary: CUDOS Score: Baseline (Visit 1) and 12 Months (Visit 3) — 21.97; 9.29 Units on a scale — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CUDOS Score: Baseline (Visit 1) and 12 Months (Visit 3) |
21.97; 9.29 | <0.001 sig |
| SECONDARY CUDOS Score: Baseline (Visit 1) and 6 Months (Visit 2) |
21.97; 12.79 | <0.001 sig |
| SECONDARY CUXOS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3) |
20.45; 12.24; 8.21 | <0.001 sig |
| SECONDARY JSEQ Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3) |
9.40; 6.63; 5.48 | <0.001 sig |
| SECONDARY VAS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3) |
61.42; 33.58; 33.75 | <0.001 sig |
| SECONDARY Number of Participants Who Took at Least 1 Concomitant Treatment of Mental Illness Per Study Visit |
4; 1; 5; 2; 0; 3 | — |
| SECONDARY Number of Participants With Change in Dosage of Concomitant Medication Between 12 Months (Visit 3) and Baseline (Visit 1) |
1; 1; 3 | — |
| SECONDARY Absolute Change From Baseline in DAS28-4 (CRP) at 6 Months (Visit 2) and 12 Months (Visit 3) |
-3.01; -3.06 | — |
| SECONDARY Number of Participants Achieving Remission as Assessed by DAS28-4 (CRP) < 2.6 |
0; 27; 26 | — |
| SECONDARY Number of Participants Achieving LDA as Assessed by DAS28-4 (CRP) < 3.2 |
0; 40; 44 | — |
| SECONDARY Change From Baseline in EuroQol Five Dimension - 3 Level (EQ-5D-3L) Health State Profile at 6 Months (Visit 2) and 12 Months (Visit 3) |
0.157; 0.179 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
15 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03992781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.