N/A
Completed N=198
Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients
Source: ClinicalTrials.gov NCT04079920 ↗Enrolled (actual)
198
Serious AEs
12.1%
Results posted
Jun 2025
Primary outcomePrimary: Percentage of Participants With Remission and Low Disease Activity (LDA) at Month 6 Assessed Using 28-Joint Disease Activity Score C-Reactive Protein (DAS28-4 CRP) — 29.6; 41.4 Percentage of participants
Summary
This is a 24-month, prospective, non-interventional, multi-center study with primary aim to identify baseline characteristics of patients that predict response at 6 months of treatment. The study also aims to describe the treatment patterns of RA patients prescribed tofacitinib in a real-world setting and assess the effect of treatment on patient quality of life and physical function. Finally the study will assess the use of healthcare resources and costs in patients with RA treated with tofacitinib in Greece.
The planned recruitment period is 12 months. The planned observation period of each patient is 12 months. In this time period up to 4 visits will be documented.
The study will be reviewed and approved by the Central Regulatory Committee for NIS and IRB Board of each participating site
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Remission and Low Disease Activity (LDA) at Month 6 Assessed Using 28-Joint Disease Activity Score C-Reactive Protein (DAS28-4 CRP) |
29.6; 41.4 | — |
| SECONDARY Percentage of Participants With Remission and LDA at Month 12 Assessed Using DAS28-4 CRP |
33.3; 55.3 | — |
| SECONDARY Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP) |
-1.25; -1.47; -1.73; -1.15; -1.42; -1.58 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3, 6 and 12 |
-0.25; -0.40; -0.40 | — |
| SECONDARY Number of Participants With Remission According to Simplified Disease Activity Index (SDAI) <=3.3 at Months 3, 6, and 12 |
12; 14; 22 | — |
| SECONDARY Number of Participants With Remission According to Clinical Disease Activity Index (CDAI) <=2.8 at Months 3, 6, and 12 |
11; 16; 24 | — |
| SECONDARY Number of Participants With Remission According to DAS28-4 ESR<2.6 at Months 3, 6, and 12 |
25; 30; 40 | — |
| SECONDARY Number of Participants With Remission According to DAS28-4 CRP <2.6 at Months 3, 6, and 12 |
31; 45; 49 | — |
| SECONDARY Number of Participants With LDA According to SDAI <=11 at Months 3, 6, and 12 |
54; 63; 74 | — |
| SECONDARY Number of Participants With LDA According to CDAI <=10 at Months 3, 6, and 12 |
56; 61; 73 | — |
| SECONDARY Number of Participants With LDA According to DAS28-4 ESR (<3.2) at Months 3, 6, and 12 |
46; 62; 65 | — |
| SECONDARY Number of Participants With LDA According to DAS28-4 CRP<=3.2 at Months 3, 6, and 12 |
59; 63; 82 | — |
| SECONDARY Percentage of Participants Achieving HAQ-DI Response at Months 3,6 and 12 |
56.6; 65.9; 71.3 | — |
| SECONDARY Change From Baseline in European Quality of Life (EuroQol) -5 Dimensions (EQ-5D) Health State Profile at Months 3, 6 and 12 |
0.18; 0.23; 0.23 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire Score at Months 3, 6 and 12 |
6.8; 7.21; 8.71 | — |
| SECONDARY Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12 |
-25.7; -29.9; -34.2; -30.42; -33.8; -37.04 | — |
| SECONDARY Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 |
3.9; 1.7; -0.08; 4.0; 4.2; 2.8 | — |
| SECONDARY Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 |
13.6; 34.3; 31.8; 17.7; 2.5; 2.0 | — |
| SECONDARY Patient Global Assessment (PtGA) at Baseline, Months 3, 6 and 12 |
59.0; 39.2; 35.8; 31.0 | — |
| SECONDARY Physician Global Assessment (PhGA) at Baseline, Months 3, 6 and 12 |
59.6; 35.9; 30.0; 27.1 | — |
| SECONDARY Number of Participants as Per Treatment Received |
59; 113; 1; 5; 2; 18 | — |
| SECONDARY Median Number of Visits to Rheumatologist or Other Rheumatoid Arthritis (RA) Specialist Since Last Visit |
0.0; 0.0; 1.0 | — |
| SECONDARY Number of Participants With Diagnostic Test Since Last Visit |
76; 59; 50 | — |
| SECONDARY Number of Participants According to the Type of Diagnostic Test |
69; 50; 42; 69; 55; 48 | — |
| SECONDARY Number of Diagnostic Tests Since Last Visit |
488; 292; 323 | — |
| SECONDARY Number of Participants Hospitalized Since Last Visit |
3; 0; 1 | — |
| SECONDARY Number of Participants Hospitalized in Daycare and Night Care Since Last Visit |
0; 0; 3; 1 | — |
| SECONDARY Mean Number of Days Participants Were Hospitalized Since Last Visit |
6.7 | — |
| SECONDARY Number of Participants According to Reason for Hospitalization Since Last Visit |
1; 0; 1; 0; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Adult subjects with moderately to severely active rheumatoid arthritis who start treatment with tofacitinib in usual clinical practice conditions in compliance with the label
- Patients aged ≥ 18 years
- Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist
- Patients with moderate to severe RA diagnosed according to local practice who have already been started on treatment with tofacitinib, for at most seven working days .
- Patients eligible for tofacitinib treatment according to current approved Summary of Product Characteristics (SmPC).
- 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.
Exclusion Criteria
- Patients meeting any of the following criteria will not be included in the study:
- Exclusion Criteria according to the Xeljanz® SmPC.
- Contraindications to Xeljanz® according to SmPC.
- Hypersensitivity to the active substance (tofacitinib) or to any of the excipients.
- Active tuberculosis (TB), serious infections, such as sepsis, or opportunistic infections.
- Receipt of any investigational drug within 3 months before study inclusion as well as currently not participating in an interventional clinical trial.
- Subjects who have received any previous treatment with tofacitinib or other JAK inhibitors.
- Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
Data sourced from ClinicalTrials.gov (NCT04079920). 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.