Trial · NCT02092467
Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
NCT02092467, Phase 4, Completed, Pfizer; results first posted 2021-08-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis. Trials, record NCT02092467. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02092467
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
- NCT number
- NCT02092467
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 4,372 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Arthritis, Rheumatoid
- Interventions
- tofacitinib, tofacitinib, adalimumab, etanercept
- First posted
- 2014-03-20
- Last updated
- 2021-08-17
- Other registries' IDs
- eudract:2013-003177-99
- Results first posted
- 2021-08-17
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC) | Baseline up to last contact date (maximum up to 72 months) | Incidence rate (number of participants with event per 100 participant year \[PY\]) was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Malignancy events, excluding NMSC were adjudicated by a steering committee. The risk period (RP) was the last contact date. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP. |
| Primary | Incidence Rate of Adjudicated Major Adverse Cardiovascular Events (MACE) | Baseline up to last contact date (maximum up to 72 months) | MACE included the cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke of any classification, including reversible focal neurologic defects with imaging evidence of a new cerebral lesion consistent with ischemia or hemorrhage. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP. |
| Secondary | Incidence Rate of Non-fatal Stroke | Baseline up to last contact date (maximum up to 72 months) | Non-fatal stroke included reversible focal neurologic defects with imaging evidence of a new cerebral lesion consistent with ischemia or hemorrhage. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP. |
| Secondary | Incidence Rate of Non-fatal Myocardial Infarction | Baseline up to last contact date (maximum up to 72 months) | Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP. |
| Secondary | Incidence Rate of Adjudicated Opportunistic Infection Events Including Tuberculosis | Baseline up to last contact date (maximum up to 72 months) | Opportunistic infections (OI) were reviewed and adjudicated by the opportunistic infection review committee (OIRC). Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP. |
| Secondary | Incidence Rate of Adjudicated Hepatic Events | Baseline up to last contact date (maximum up to 72 months) | Hepatic events (adjudicated) included drug-induced liver injury (DILI) - probable, highly likely and definite, DILI - listed separately, DILI - cases meeting classification and severity, participants with elevations of transaminase levels greater than (\>) 1\* upper limit of normal (ULN), greater than or equal to (\>=) 3\*ULN, \>=5\*ULN (based on laboratory values). Incidence rate was the total number of participants with admissible events divided by total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was minimum of The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. Last contact date was maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). In case of death, last contact date was death date. First events counted within RP. Participant did not have an event or had an event outside risk period were censored at end of RP. |
| Secondary | Incidence Rate of Adjudicated Cardiovascular Events Other Than Major Adverse Cardiovascular Events (MACE) | Baseline up to last contact date (maximum up to 72 months) | Cardiovascular events (adjudicated) were death (coronary and non-coronary), MI, all coronary revascularization, unstable angina, new ischemic heart disease, stroke (fatal and non-fatal), transient ischemic attack (TIA), congestive heart failure (CHF), peripheral arterial vascular disease (PAVD), deep vein thrombosis, pulmonary embolism, arterial embolism, arterial thrombosis. Incidence rate was total number of participants with admissible events divided by total (for all qualifying participants) time at risk for cohort/treatment group of interest. Risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. Last contact date was maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). In case of death, last contact date was death date. First events counted within RP. Participant did not have an event or had an event outside risk period were censored at end of RP. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs: Baseline up to minimum of last contact date or last study treatment dose date+28 days (maximum up to 72 months); SAEs: Baseline up to minimum of last contact date (maximum up to 72 months) | AE was any untoward medical occurrence post treatment; event need not necessarily had causal relationship with treatment or usage. SAE: any untoward medical occurrence at any dose: resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly. TEAE: event that occurred for first time during effective duration of treatment and not seen prior to start of treatment or event seen prior to start of treatment but increase in severity during treatment. Risk period (RP) for AE: minimum of last contact date or last study treatment dose date+28 days. RP for SAEs: last contact date. Last contact date was maximum: AE start, AE stop, last study visit, withdrawal and telephone contact. In case of death, last contact was death date. First events counted within RP. Participant did not have event or had event outside risk period were censored at end of RP. |
| Secondary | Number of Participants With Clinically Significant Abnormal Laboratory Parameters | Baseline up to last contact date (maximum up to 72 months) | Clinically significant laboratory abnormalities: Hematology: hemoglobin, hematocrit, erythrocytes with primary criteria as less than \[\<\] 0.8\* lower limit of normal \[LLN\]), platelets (\<0.5\* LLN; \>1.75\* ULN), leukocytes (\<0.6\*LLN; \>1.5\*ULN), lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes (\<0.8\*LLN; \>1.2\*ULN), eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes (\>1.2\*ULN); urinalysis: urine glucose, urine protein, urine hemoglobin, and leukocyte esterase (\>=1); chemistry: bilirubin, indirect bilirubin (\>1.5\*ULN) aspartate aminotransferase, alanine aminotransferase (\>3.0\*ULN), creatinine, triglycerides, cholesterol (\>1.3\*ULN) and HDL cholesterol (\<0.8\*LLN). Risk period (RP) was minimum of last contact date or last study treatment dose date+28 days. Last contact date was (date of death or maximum of dates: AE start, AE stop, last study visit, withdrawal, telephone contact). Participants without event or event outside RP were censored at end of RP. |
| Secondary | Incidence Rate of Adjudicated All-Cause Deaths | Baseline up to last contact date (maximum up to 72 months) | All-cause death was defined as the death due to any cause during the course of study. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Incidence rate of all-cause deaths (adjudicated by Adjudication Committee) was reported in this outcome measure. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC) | Baseline up to last contact date (maximum up to 72 months) | SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi). | participants with event/100 PY | NUMBER |
| PRIMARY | Incidence Rate of Adjudicated Major Adverse Cardiovascular Events (MACE) | Baseline up to last contact date (maximum up to 72 months) | SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi). | participants with event/100 PY | NUMBER |
| SECONDARY | Incidence Rate of Non-fatal Stroke | Baseline up to last contact date (maximum up to 72 months) | SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi). | participants with event/100 PY | NUMBER |
| SECONDARY | Incidence Rate of Non-fatal Myocardial Infarction | Baseline up to last contact date (maximum up to 72 months) | SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi). | participants with event/100 PY | NUMBER |
| SECONDARY | Incidence Rate of Adjudicated Opportunistic Infection Events Including Tuberculosis | Baseline up to last contact date (maximum up to 72 months) | SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi). | participants with event/100 PY | NUMBER |
| SECONDARY | Incidence Rate of Adjudicated Hepatic Events | Baseline up to last contact date (maximum up to 72 months) | SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi). | participants with event/100 PY | NUMBER |
| SECONDARY | Incidence Rate of Adjudicated Cardiovascular Events Other Than Major Adverse Cardiovascular Events (MACE) | Baseline up to last contact date (maximum up to 72 months) | SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi). | participants with event/100 PY | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs: Baseline up to minimum of last contact date or last study treatment dose date+28 days (maximum up to 72 months); SAEs: Baseline up to minimum of last contact date (maximum up to 72 months) | SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormal Laboratory Parameters | Baseline up to last contact date (maximum up to 72 months) | Analysis population included all participants from SAS with an abnormal baseline with at least one observation of the given laboratory test while on study treatment or during lag time. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence Rate of Adjudicated All-Cause Deaths | Baseline up to last contact date (maximum up to 72 months) | SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi). | participants with event/100 PY | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group1,010
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC) | Tofacitinib 5 mg BID | 1.13 | 95% Confidence Interval 0.87 to 1.45 | participants with event/100 PY | |
| Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC) | Tofacitinib 10 mg BID | 1.13 | 95% Confidence Interval 0.86 to 1.45 | participants with event/100 PY | |
| Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC) | All Tofacitinib | 1.13 | 95% Confidence Interval 0.94 to 1.35 | participants with event/100 PY | |
| Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC) | TNFi | 0.77 | 95% Confidence Interval 0.55 to 1.04 | participants with event/100 PY | |
| Incidence Rate of Adjudicated Major Adverse Cardiovascular Events (MACE) | Tofacitinib 5 mg BID | 0.91 | 95% Confidence Interval 0.67 to 1.21 | participants with event/100 PY | |
| Incidence Rate of Adjudicated Major Adverse Cardiovascular Events (MACE) | Tofacitinib 10 mg BID | 1.05 | 95% Confidence Interval 0.78 to 1.38 | participants with event/100 PY | |
| Incidence Rate of Adjudicated Major Adverse Cardiovascular Events (MACE) | All Tofacitinib | 0.98 | 95% Confidence Interval 0.79 to 1.19 | participants with event/100 PY | |
| Incidence Rate of Adjudicated Major Adverse Cardiovascular Events (MACE) | TNFi | 0.73 | 95% Confidence Interval 0.52 to 1.01 | participants with event/100 PY | |
| Incidence Rate of Non-fatal Stroke | Tofacitinib 5 mg BID | 0.27 | 95% Confidence Interval 0.15 to 0.45 | participants with event/100 PY | |
| Incidence Rate of Non-fatal Stroke | Tofacitinib 10 mg BID | 0.33 | 95% Confidence Interval 0.19 to 0.53 | participants with event/100 PY |
1 to 10 of 1,010Source ClinicalTrials.gov
See all 1,010 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tofacitinib 5 mg BID | 1,457 | |
| Overall Study | STARTED | Tofacitinib 10 mg BID | 1,457 | |
| Overall Study | STARTED | TNFi | 1,458 | |
| Overall Study | Treated | Tofacitinib 5 mg BID | 1,455 | |
| Overall Study | Treated | Tofacitinib 10 mg BID | 1,456 | |
| Overall Study | Treated | TNFi | 1,451 | |
| Overall Study | COMPLETED | Tofacitinib 5 mg BID | 1,053 | |
| Overall Study | COMPLETED | Tofacitinib 10 mg BID | 998 | |
| Overall Study | COMPLETED | TNFi | 1,060 | |
| Overall Study | NOT COMPLETED | Tofacitinib 5 mg BID | 404 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2,091
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 | Anaemia | Blood and lymphatic system disorders | Tofacitinib 5 mg BID | 75 | 1,455 | |
| other | Anaemia | Blood and lymphatic system disorders | Tofacitinib 10 mg BID | 100 | 1,456 | |
| other | Anaemia | Blood and lymphatic system disorders | TNFi | 73 | 1,451 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Tofacitinib 5 mg BID | 107 | 1,455 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Tofacitinib 10 mg BID | 151 | 1,456 | |
| other | Lymphopenia | Blood and lymphatic system disorders | TNFi | 36 | 1,451 | |
| other | Diarrhoea | Gastrointestinal disorders | Tofacitinib 5 mg BID | 99 | 1,455 | |
| other | Diarrhoea | Gastrointestinal disorders | Tofacitinib 10 mg BID | 81 | 1,456 | |
| other | Diarrhoea | Gastrointestinal disorders | TNFi | 74 | 1,451 | |
| other | Nausea | Gastrointestinal disorders | Tofacitinib 5 mg BID | 67 | 1,455 |
1 to 10 of 2,091Source ClinicalTrials.gov
See all 2,091 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tofacitinib 5 mg BID | 49 | 1,455 |
| Total, all-cause mortality | Tofacitinib 10 mg BID | 66 | 1,456 |
| Total, all-cause mortality | TNFi | 38 | 1,451 |
| Total, other adverse events | Tofacitinib 5 mg BID | 1,108 | 1,455 |
| Total, other adverse events | Tofacitinib 10 mg BID | 1,127 | 1,456 |
| Total, other adverse events | TNFi | 1,056 | 1,451 |
| Total, serious adverse events | Tofacitinib 5 mg BID | 373 | 1,455 |
| Total, serious adverse events | Tofacitinib 10 mg BID | 420 | 1,456 |
| Total, serious adverse events | TNFi | 339 | 1,451 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
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/NCT02092467
GET https://conductscience.org/api/trials/v1/NCT02092467/registered?page=2