N/A
Completed N=9,652
Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01932372 ↗Enrolled (actual)
9,652
Serious AEs
17.0%
Results posted
Oct 2024
Primary outcomePrimary: Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ — 41.60; 12.88 Percentage of Participants
Summary
The objective of this Surveillance is to verify the following subject matters concerning Tofacitinib (Xeljanz) under general practice.
1) Occurrence of adverse reactions, factors that may potentially affect safety and efficacy 2） Long-term safety (particularly, malignant tumors and serious infections) and efficacy
Occurrences of malignant tumors and serious infections will be compared with a control group.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ |
41.60; 12.88 | — |
| PRIMARY Change in Disease Activity Based on Simplified Disease Activity Index (SDAI) |
-10.16; -14.59; -15.97; -16.88; -17.37 | — |
| PRIMARY Change in Disease Activity Score Based on 28-joints Count (DAS28) |
-0.98; -1.52; -1.67; -1.82; -1.86 | — |
| SECONDARY Occurrence of Serious Infection Events |
6.86; 1.42 | — |
| SECONDARY Occurrence of Malignancy |
1.40; 0.88; 1.38; 0.98 | — |
| SECONDARY Occurrence of Death |
0.89; 0.26; 1.02; 0.39 | — |
Eligibility Criteria
Inclusion Criteria
- All patients receiving Tofacitinib (Xeljanz)
Exclusion Criteria
Not Applicable
Data sourced from ClinicalTrials.gov (NCT01932372). 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.