0 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZPrimary· 36 months
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XELJANZ in a participant who received XELJANZ. A serious adverse event/adverse drug reaction (SADR) was a treatment-related adverse event 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.
ADR
Group
Value
95% CI
XELJANZ (MTX Adherent Safety Analysis Set)
41.60
Serious ADR
Group
Value
95% CI
XELJANZ (MTX Adherent Safety Analysis Set)
12.88
Occurrence of Serious Infection EventsSecondary· 12 months
Comparison of time to serious infection between XELJANZ group and control group.
Hazard ratio (unadjusted): Baseline characteristics are unadjusted Hazard ratio (adjusted 1): Adjusted by propensity score estimated by logistic regression Hazard ratio (adjusted 2): Adjusted by propensity score estimated by random forest Hazard ratio (adjusted 3): Adjusted by propensity score estimated by logistic regression (with upper limit of weighting) Hazard ratio (adjusted 4): Adjusted by propensity score estimated by random forest (with upper limit of weighting)
Control (MTX Adherent Comparative Safety Analysis Set)
1.42
0.97 – 2.00
Occurrence of MalignancySecondary· 36 months
Comparison of time to malignancy between XELJANZ group and control group. The standard incidence ratio (SIR) was calculated using the general Japanese population as the reference population.
Hazard ratio (unadjusted): Baseline characteristics are unadjusted Hazard ratio (adjusted 1): Adjusted by propensity score estimated by logistic regression Hazard ratio (adjusted 2): Adjusted by propensity score estimated by random forest Hazard ratio (adjusted 3): Adjusted by propensity score estimated by logistic regression (with upper limit of weighting) Hazard ratio (adjusted 4): Adjusted by propensit
Control (MTX Adherent Comparative Safety Analysis Set)
0.98
0.73 – 1.28
Occurrence of DeathSecondary· 36 months
Comparison of time to death between XELJANZ group and control group. The standardized mortality ratio (SMR) was calculated using the general Japanese population as the reference population.
Hazard ratio (unadjusted): Baseline characteristics are unadjusted
Control (MTX Adherent Comparative Safety Analysis Set)
0.39
0.23 – 0.64
Change in Disease Activity Based on Simplified Disease Activity Index (SDAI)Primary· Baseline, 1, 6, 12, 24, 36 months
The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS, and C-reactive protein (CRP) (mg/dL). SDAI is defined as follows: ≤3.3, disease remission; \>3.3 to ≤11, low disease activity, \>11 to ≤26, moderate disease activity; and \>26, high disease activity. SDAI was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI.
Group
Value
95% CI
XELJANZ (MTX Adherent Efficacy Analysis Set) At 1 Month From Baseline
-10.16
-10.69 – -9.62
XELJANZ (MTX Adherent Efficacy Analysis Set) At 6 Months From Baseline
-14.59
-15.10 – -14.07
XELJANZ (MTX Adherent Efficacy Analysis Set) At 12 Months From Baseline
-15.97
-16.62 – -15.32
XELJANZ (MTX Adherent Efficacy Analysis Set) At 24 Months From Baseline
-16.88
-17.64 – -16.12
XELJANZ (MTX Adherent Efficacy Analysis Set) At 36 Months From Baseline
-17.37
-18.21 – -16.53
Change in Disease Activity Score Based on 28-joints Count (DAS28)Primary· Baseline, 1, 6, 12, 24, 36 months
DAS28 is the numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, PtGA assessed on 0-10 cm VAS, and the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]). DAS28 is defined as follows: \<2.6, disease remission; ≥2.6 to \<3.2, low disease activity, ≥3.2 to ≤5.1, moderate disease activity; and \>5.1, high disease activity. DAS28 was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI.
Group
Value
95% CI
XELJANZ (MTX Adherent Efficacy Analysis Set) At 1 Month From Baseline
-0.98
-1.04 – -0.92
XELJANZ (MTX Adherent Efficacy Analysis Set) At 6 Months From Baseline
-1.52
-1.58 – -1.46
XELJANZ (MTX Adherent Efficacy Analysis Set) At 12 Months From Baseline
-1.67
-1.75 – -1.59
XELJANZ (MTX Adherent Efficacy Analysis Set) At 24 Months From Baseline
-1.82
-1.91 – -1.73
XELJANZ (MTX Adherent Efficacy Analysis Set) At 36 Months From Baseline
-1.86
-1.96 – -1.76
Adverse events — posted to ClinicalTrials.gov
Time frame: 36 months.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 26 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01932372.