Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Escalations |
249; 130; 101; 48; 29; 51 | — |
| PRIMARY Time to Treatment Escalation |
288.21; 278.47; 221.95; 308.11; 240.39; 219.47 | — |
| SECONDARY Time to First Step Up Treatment Escalation |
611.33; 599.17; 268.07; 555.69 | — |
| SECONDARY Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
281; 164; 31; 63; 256; 127 | — |
| SECONDARY Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
348; 197; 40; 71; 315; 162 | — |
| SECONDARY Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
253; 155; 32; 57; 224; 131 | — |
| SECONDARY Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
308; 175; 38; 65; 280; 136 | — |
| SECONDARY Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
21; 15; 1; 8; 22; 13 | — |
| SECONDARY Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
72; 47; 4; 21; 71; 40 | — |
| SECONDARY Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
94; 65; 8; 28; 96; 61 | — |
| SECONDARY Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
162; 101; 17; 45; 143; 97 | — |
| SECONDARY Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
238; 125; 27; 55; 208; 104 | — |
| SECONDARY Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
-1.47; -1.36; -1.03; -1.69; -1.52; -1.49 | — |
| SECONDARY Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
-1.55; -1.40; -1.04; -1.63; -1.72; -1.52 | — |
| SECONDARY Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
-27.71; -22.23; -44.73; -26.48; -29.00; -25.74 | — |
| SECONDARY Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
6.73; 5.31; 8.82; 6.52; 8.73; 6.12 | — |
| SECONDARY Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
174; 114; 18; 47; 157; 102 | — |
| SECONDARY Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
0.119; 0.109; 0.079; 0.102; 0.134; 0.110 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
4.83; 3.59; 3.71; 3.35; 5.57; 4.25 | — |
| SECONDARY Mean Number of Days of Drug Survival at Months 12 and 24 |
339.83; 341.17; 233.30; 337.36; 534.49; 542.15 | — |
| SECONDARY Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 |
43; 19; 5; 11; 41; 26 | — |
Eligibility Criteria
Inclusion Criteria
Patients aged ≥ 18 years
Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist
Patient is eligible for Tofacitinib treatment according to 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
Contraindications according to Xeljanz® SmPC
Receipt of any investigational drug within 3 months before study inclusion
Patients who have received any previous treatment with Tofacitinib or other JAK inhibitors
Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the study.
Data sourced from ClinicalTrials.gov (NCT03387423). 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.