Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

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• Arthritis 3,554
• Arthritis, Rheumatoid 2,888

Keywords

• Rheumatoid Arthritis
• Good Post Marketing Study Practice
• Tofacitinib
• Xeljanz
• Regulatory Post Marketing Commitment Plan

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 9,968 is above the median of 155 across 1,057 observational studies indexed under Arthritis.

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Study population

Groups and cohorts

• Tofacitinib (Xeljanz)

  Tablets 5 mg BID

  Drug: Tofacitinib (Xeljanz)

• Standard of Care

  Standard of Care for Rheumatoid Arthritis

  Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc

Interventions

• DrugTofacitinib (Xeljanz)

  5 mg Tablet BID

• DrugEtanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc

  Etanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly

Primary outcomes

1. Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ

   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.

   Time frame: 36 months

2. Change in Disease Activity Based on Simplified Disease Activity Index (SDAI)

   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.

   Time frame: Baseline, 1, 6, 12, 24, 36 months

3. Change in Disease Activity Score Based on 28-joints Count (DAS28)

   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.

   Time frame: Baseline, 1, 6, 12, 24, 36 months

Secondary outcomes

1. Occurrence of Serious Infection Events

   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)

   Time frame: 12 months

2. Occurrence of Malignancy

   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 propensity score estimated by random forest (with upper limit of weighting)

   Time frame: 36 months

3. Occurrence of Death

   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

   Time frame: 36 months

Baseline characteristics

Related links

• To obtain contact information for a study center near you, click here. ↗

Study documents

• Study protocol · Feb 27, 2018
• Statistical analysis plan · Dec 6, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.