Trial · NCT01932372
Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis
NCT01932372, Completed, Pfizer; results first posted 2024-10-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis. Trials, record NCT01932372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01932372
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis
- NCT number
- NCT01932372
- Status
- Completed
- Enrollment
- 9,968 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Rheumatoid Arthritis
- Interventions
- Tofacitinib (Xeljanz), Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc
- First posted
- 2013-08-30
- Last updated
- 2024-10-26
- Results first posted
- 2024-10-26
- Limitations and caveats
According to the protocol, only three events, Serious Infection, Malignancy, and Death were collected in the control group for comparison with the Xeljanz group and other serious AEs or non-serious AEs were not to be collected although all AEs were collected in Xeljanz group. However several serious and non-serious AEs other than three events were incidentally reported by the investigators in the control group. Note that these AEs do not represent all AEs occurred in the control group.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ | 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. |
| Primary | Change in Disease Activity Based on Simplified Disease Activity Index (SDAI) | 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. |
| Primary | Change in Disease Activity Score Based on 28-joints Count (DAS28) | 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. |
| Secondary | Occurrence of Serious Infection Events | 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) |
| Secondary | Occurrence of Malignancy | 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 propensity score estimated by random forest (with upper limit of weighting) |
| Secondary | Occurrence of Death | 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 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ | 36 months | The MTX adherent safety analysis set (n=4574) comprised of participants who received XELJANZ Tablets 5 mg at least once for the treatment of poorly controlled RA despite continuous use of MTX, excluding participants who did not meet the conditions to receive MTX, participated in a clinical trial, or transferred to another hospital. | Percentage of Participants | NUMBER |
| SECONDARY | Occurrence of Serious Infection Events | 12 months | The MTX adherent comparative safety analysis set comprised of participants who satisfied the inclusion criteria and had received XELJANZ Tablets 5 mg or other treatment at least once for the treatment of poorly controlled RA despite continuous use of MTX. | Incidence rate; participants /100 PY | NUMBER |
| SECONDARY | Occurrence of Malignancy | 36 months | The MTX adherent comparative safety analysis set comprised of participants who satisfied the inclusion criteria and had received XELJANZ Tablets 5 mg or other treatment at least once for the treatment of poorly controlled RA despite continuous use of MTX. | Incidence rate; participants /100 PY | NUMBER |
| SECONDARY | Occurrence of Death | 36 months | The MTX adherent comparative safety analysis set comprised of participants who satisfied the inclusion criteria and had received XELJANZ Tablets 5 mg or other treatment at least once for the treatment of poorly controlled RA despite continuous use of MTX. | Mortality rate; participants /100 PY | NUMBER |
| PRIMARY | Change in Disease Activity Based on Simplified Disease Activity Index (SDAI) | Baseline, 1, 6, 12, 24, 36 months | The MTX adherent efficacy analysis set (n=4455) comprised of participants who received XELJANZ Tablets 5 mg at least once for the treatment of poorly controlled RA despite continuous use of MTX, excluding participants who were confirmed ineligible or not assessable for effectiveness. Of the 4455 MTX adherent efficacy analysis set, the participants with available results at each evaluation point are described. | Scores on a scale | MEAN |
| PRIMARY | Change in Disease Activity Score Based on 28-joints Count (DAS28) | Baseline, 1, 6, 12, 24, 36 months | The MTX adherent efficacy analysis set (n=4455) comprised of participants who received XELJANZ Tablets 5 mg at least once for the treatment of poorly controlled RA despite continuous use of MTX, excluding participants who were confirmed ineligible or not assessable for effectiveness. Of the 4455 MTX adherent efficacy analysis set, the participants with available results at each evaluation point are described. | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ | XELJANZ (MTX Adherent Safety Analysis Set) | ADR | 41.60 | Percentage of Participants | |
| Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ | XELJANZ (MTX Adherent Safety Analysis Set) | Serious ADR | 12.88 | Percentage of Participants | |
| Occurrence of Serious Infection Events | XELJANZ (MTX Adherent Comparative Safety Analysis Set) | 6.86 | 95% Confidence Interval 5.96 to 7.86 | Incidence rate; participants /100 PY | |
| Occurrence of Serious Infection Events | Control (MTX Adherent Comparative Safety Analysis Set) | 1.42 | 95% Confidence Interval 0.97 to 2.00 | Incidence rate; participants /100 PY | |
| Occurrence of Malignancy | XELJANZ (MTX Adherent Comparative Safety Analysis Set) | Incidence rate | 1.40 | 95% Confidence Interval 1.18 to 1.66 | Incidence rate; participants /100 PY |
| Occurrence of Malignancy | Control (MTX Adherent Comparative Safety Analysis Set) | Incidence rate | 0.88 | 95% Confidence Interval 0.66 to 1.15 | Incidence rate; participants /100 PY |
| Occurrence of Malignancy | XELJANZ (MTX Adherent Comparative Safety Analysis Set) | SIR | 1.38 | 95% Confidence Interval 1.16 to 1.62 | Incidence rate; participants /100 PY |
| Occurrence of Malignancy | Control (MTX Adherent Comparative Safety Analysis Set) | SIR | 0.98 | 95% Confidence Interval 0.73 to 1.28 | Incidence rate; participants /100 PY |
| Occurrence of Death | XELJANZ (MTX Adherent Comparative Safety Analysis Set) | Mortality rate | 0.89 | 95% Confidence Interval 0.72 to 1.10 | Mortality rate; participants /100 PY |
| Occurrence of Death | Control (MTX Adherent Comparative Safety Analysis Set) | Mortality rate | 0.26 | 95% Confidence Interval 0.15 to 0.43 | Mortality rate; participants /100 PY |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | XELJANZ (Safety Analysis Set) | 7,054 | |
| Overall Study | STARTED | Control (MTX Adherent Comparative Safety Analysis Set) | 2,598 | |
| Overall Study | XELJANZ (Safety Analysis Set) | XELJANZ (Safety Analysis Set) | 7,021 | |
| Overall Study | XELJANZ (Safety Analysis Set) | Control (MTX Adherent Comparative Safety Analysis Set) | 2,419 | |
| Overall Study | XELJANZ (MTX Adherent Safety Analysis Set) | XELJANZ (Safety Analysis Set) | 4,574 | |
| Overall Study | XELJANZ (MTX Adherent Safety Analysis Set) | Control (MTX Adherent Comparative Safety Analysis Set) | 0 | |
| Overall Study | XELJANZ (MTX Adherent Comparative Safety Analysis Set) | XELJANZ (Safety Analysis Set) | 3,731 | |
| Overall Study | XELJANZ (MTX Adherent Comparative Safety Analysis Set) | Control (MTX Adherent Comparative Safety Analysis Set) | 0 | |
| Overall Study | COMPLETED | XELJANZ (Safety Analysis Set) | 7,021 | |
| Overall Study | COMPLETED | Control (MTX Adherent Comparative Safety Analysis Set) | 2,419 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,824
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hepatic function abnormal | Hepatobiliary disorders | XELJANZ (Safety Analysis Set) | 284 | 7,021 | |
| other | Hepatic function abnormal | Hepatobiliary disorders | XELJANZ (MTX Adherent Comparative Safety Analysis Set) | 194 | 3,731 | |
| other | Hepatic function abnormal | Hepatobiliary disorders | Control (MTX Adherent Comparative Safety Analysis Set) | 3 | 2,419 | |
| other | Bronchitis | Infections and infestations | XELJANZ (Safety Analysis Set) | 167 | 7,021 | |
| other | Bronchitis | Infections and infestations | XELJANZ (MTX Adherent Comparative Safety Analysis Set) | 98 | 3,731 | |
| other | Bronchitis | Infections and infestations | Control (MTX Adherent Comparative Safety Analysis Set) | 2 | 2,419 | |
| other | Herpes zoster | Infections and infestations | XELJANZ (Safety Analysis Set) | 547 | 7,021 | |
| other | Herpes zoster | Infections and infestations | XELJANZ (MTX Adherent Comparative Safety Analysis Set) | 325 | 3,731 | |
| other | Herpes zoster | Infections and infestations | Control (MTX Adherent Comparative Safety Analysis Set) | 15 | 2,419 | |
| other | Nasopharyngitis | Infections and infestations | XELJANZ (Safety Analysis Set) | 203 | 7,021 |
1 to 10 of 1,824Source ClinicalTrials.gov
See all 1,824 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | XELJANZ (Safety Analysis Set) | 188 | 7,021 |
| Total, all-cause mortality | XELJANZ (MTX Adherent Comparative Safety Analysis Set) | 98 | 3,731 |
| Total, all-cause mortality | Control (MTX Adherent Comparative Safety Analysis Set) | 16 | 2,419 |
| Total, other adverse events | XELJANZ (Safety Analysis Set) | 1,340 | 7,021 |
| Total, other adverse events | XELJANZ (MTX Adherent Comparative Safety Analysis Set) | 814 | 3,731 |
| Total, other adverse events | Control (MTX Adherent Comparative Safety Analysis Set) | 28 | 2,419 |
| Total, serious adverse events | XELJANZ (Safety Analysis Set) | 1,351 | 7,021 |
| Total, serious adverse events | XELJANZ (MTX Adherent Comparative Safety Analysis Set) | 773 | 3,731 |
| Total, serious adverse events | Control (MTX Adherent Comparative Safety Analysis Set) | 112 | 2,419 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37405710 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01932372
GET https://conductscience.org/api/trials/v1/NCT01932372/results?page=2