Ulcerative Colitis
Conditions
Keywords
Xeljanz, Ulcerative colitis, UC, Long-term
Brief summary
Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice
Detailed description
This investigation aims to examine the safety and effectiveness of Xeljanz in post-marketing clinical settings when it is administered chronically to patients with ulcerative colitis, based on the approval conditions.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with ulcerative colitis treated with XELJANZ * Patients naive to XELJANZ in the treatment of ulcerative colitis
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reactions | 60 weeks | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XELJANZ in a participant who received XELJANZ. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XELJANZ was assessed by the physician. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| XELJANZ Tablets 5 mg (Tofacitinib Citrate) Participants who received XELJANZ as indicated in the approved local product document were observed for a period of 60 weeks. The dosage can be adjusted as per physician's discretion. | 1,995 |
| Total | 1,995 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Contract violation/deficiency | 12 |
| Overall Study | Invalid registration | 3 |
| Overall Study | No adverse event information - No revisit | 4 |
| Overall Study | No treatment information | 2 |
Baseline characteristics
| Characteristic | XELJANZ Tablets 5 mg (Tofacitinib Citrate) | — |
|---|---|---|
| Age, Customized ≥15 and <65 years | 1770 Participants | — |
| Age, Customized <15 years | 12 Participants | — |
| Age, Customized ≥65 years | 213 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex/Gender, Customized Female | 782 Participants | — |
| Sex/Gender, Customized Male | 1208 Participants | — |
| Sex/Gender, Customized Unknown | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 1,995 |
| other Total, other adverse events | 586 / 1,995 |
| serious Total, serious adverse events | 103 / 1,995 |
Outcome results
Primary
Number of Participants With Adverse Drug Reactions
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XELJANZ in a participant who received XELJANZ. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XELJANZ was assessed by the physician.
Time frame: 60 weeks
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received XELJANZ at least once. Participants with contract violation/deficiency, invalid registration, no treatment information, and no adverse event information - no revisit were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XELJANZ Tablets 5 mg (Tofacitinib Citrate) | Number of Participants With Adverse Drug Reactions | ADR | 466 Participants |
| XELJANZ Tablets 5 mg (Tofacitinib Citrate) | Number of Participants With Adverse Drug Reactions | Serious ADR | 46 Participants |