N/A
Completed N=314
IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT03981900 ↗
Enrolled (actual)
314
Serious AEs
20.7%
Results posted
Oct 2024
Primary outcomePrimary: Duration of Tofacitinib Drug Survival — 26.4 Months
Summary
Regarding Tofacitinib, newly introduced on the market, few data on drug retention and no data on the factors predictive of Tofacitinib drug survival in patients with RA are available.
Therefore, the primary objective of the DeFacTo study will be to identify the factors predictive of Tofacitinib drug survival in patients with RA.
As secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Tofacitinib Drug Survival |
26.4 | — |
| SECONDARY Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24 |
20.4; -5.2; -6.6; -8.4; -8.2; -8.8 | — |
| SECONDARY Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 |
13.2; 8.4; 7.3; 11.3; 5.6; -0.4 | — |
| SECONDARY Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Index 28 (DAS28)-4 Erythrocyte Sedimentation Rate (ESR) (<=3.2) |
7.2; 34.9; 46.4; 52.4; 57.0; 55.2 | — |
| SECONDARY Percentage of Participants With LDA According to DAS28-4 C Reactive Protein (CRP) (<=3.2) |
9.8; 46.2; 55.9; 69.3; 66.0; 71.9 | — |
| SECONDARY Percentage of Participants With LDA According to Simplified Disease Activity Index (SDAI) <=11 |
6.6; 39.4; 54.0; 67.2; 64.7; 68.2 | — |
| SECONDARY Percentage of Participants With LDA According to Clinical Disease Activity Index (CDAI) <=10 |
6.1; 41.8; 56.4; 67.0; 66.3; 68.8 | — |
| SECONDARY Percentage of Participants With Remission According to DAS28-4 ESR<2.6 |
3.6; 17.8; 27.6; 34.9; 32.6; 33.6 | — |
| SECONDARY Percentage of Participants With Remission According to DAS28-4 CRP <2.6 |
4.9; 29.3; 37.3; 46.4; 48.1; 48.9 | — |
| SECONDARY Percentage of Participants in Remission According to SDAI <=3.3 |
1.1; 6.7; 13.7; 23.1; 29.3; 31.0 | — |
| SECONDARY Percentage of Participants in Remission According to CDAI<=2.8 |
0.7; 6.7; 14.8; 21.5; 26.5; 26.2 | — |
| SECONDARY Percentage of Participants With Remission According to American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) 2011 Boolean Criteria |
2.7; 8.9; 14.9; 22.0; 24.6; 26.6 | — |
| SECONDARY Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24 |
4.850; -1.129; -1.419; -1.941; -1.764; -1.954 | — |
| SECONDARY Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24 |
4.526; -1.295; -1.498; -1.902; -1.909; -1.971 | — |
| SECONDARY Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) |
67; 61; 49; 97; 63; 51 | — |
| SECONDARY Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24 |
7.4; -4.2; -4.3; -4.9; -5.0; -5.1 | — |
| SECONDARY Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24 |
5.3; -3.0; -3.5; -3.9; -4.3; -4.4 | — |
| SECONDARY Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response |
156; 91; 124; 60; 149; 56 | — |
| SECONDARY Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24 |
51.5; -24.3; -31.3; -31.5; -36.6; -32.2 | — |
| SECONDARY Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 |
100; 139; 17; 89; 91; 7 | — |
| SECONDARY Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24 |
0.3987; 0.1314; 0.1767; 0.1886; 0.2362; 0.2190 | — |
| SECONDARY Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24 |
35.0; 3.5; 5.8; 5.9; 6.9; 6.9 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24 |
26.9; 3.9; 6.2; 6.2; 6.9; 6.8 | — |
| SECONDARY Number of Participants With Tofacitinib Tolerance Issue |
39 | — |
Eligibility Criteria
Inclusion Criteria
- Patient 18 years of age or older
- Patient in whom the diagnosis of moderate to severe active rheumatoid arthritis has been confirmed by a rheumatologist
- Patient for whom the rheumatologist decides to initiate treatment with Tofacitinib
- Patient informed of the study
Exclusion Criteria
- Patient participating in a randomised clinical trial.
- Patient presenting with a contraindication to prescription of Tofacitinib
- Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the trial.
Data sourced from ClinicalTrials.gov (NCT03981900). 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.