Trial · NCT02092467
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| 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 |
| SECONDARY | Number of Participants With Reasons For Permanent or Temporary Discontinuation of Study Medication | 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 | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 | Baseline, Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 | Full Analysis Set (FAS): all participants randomized and received at least one dose of drug. Mixed model for repeated measures used without imputation for missing values. Analyses included data while participants were receiving drug. Only visits with N \> 50 participants in each treatment group included in analyses. Number of Participants Analyzed: number of participants included in mixed model for repeated measures. Number Analyzed: number of participants evaluable for each specified time point. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 | Baseline, Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 | FAS: all participants randomized and received at least one dose of drug. Mixed model for repeated measures used without imputation for missing values. Analyses included data while participants were receiving drug. Only visits with N \> 50 participants in each treatment group included in analyses. Number of Participants Analyzed: number of participants included in mixed model for repeated measures. Number Analyzed: number of participants evaluable for each specified time point. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 | Baseline, Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 | FAS: all participants randomized and received at least one dose of drug. Mixed model for repeated measures used without imputation for missing values. Analyses included data while participants were receiving drug. Only visits with N \> 50 participants in each treatment group included in analyses. Number of Participants Analyzed: number of participants included in mixed model for repeated measures. Number Analyzed: number of participants evaluable for each specified time point. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria | Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72 | FAS included all participants randomized in study and received at least one dose of randomized investigational drug. Analyses included data while participants were receiving the study drug. 'Number Analyzed' signifies number of participants evaluable for each specified time point. Last Observation Carried Forward (LOCF) applied for missing components and composite binary outcome was calculated. The percentages were calculated using numbers of participants evaluable at each visit as denominators. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 | Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72 | FAS included all participants randomized in the study and received at least one dose of investigational drug. Analyses included the data while the participants were receiving the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for each specified time point. LOCF was applied for missing components, and then composite binary outcome was calculated. The percentages were calculated using the numbers of participants evaluable at each visit as the denominators. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 | Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72 | FAS included all participants randomized in the study and received at least one dose of investigational drug. Analyses included the data while the participants were receiving the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for each specified time point. LOCF was applied for missing components, and then composite binary outcome was calculated. The percentages were calculated using the numbers of participants evaluable at each visit as the denominators. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 | Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72 | FAS included all participants randomized in the study and received at least one dose of investigational drug. Analyses included the data while the participants were receiving the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for each specified time point. LOCF was applied for missing components, and then composite binary outcome was calculated. The percentages were calculated using the numbers of participants evaluable at each visit as the denominators. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 | Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72 | FAS included all participants randomized in the study and received at least one dose of investigational drug. Analyses included the data while the participants were receiving the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for each specified time point. LOCF was applied for missing components, and then composite binary outcome was calculated. The percentages were calculated using the numbers of participants evaluable at each visit as the denominators. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 | Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72 | FAS included all participants randomized in the study and received at least one dose of investigational drug. Analyses included the data while the participants were receiving the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for each specified time point. LOCF was applied for missing components, and then composite binary outcome was calculated. The percentages were calculated using the numbers of participants evaluable at each visit as the denominators. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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