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Trial · NCT05576051

Outcomes21

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYClinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX)At month 6 follow up visit
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Number Analyzed (n) signifies number of participants evaluable for specified rows.
Units on a scaleMEAN
SECONDARYCDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTXAt month 6 follow up visit
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, n signifies number of participants evaluable for specified rows. Due to change in planned analysis, data for TNFi initiators after 11/6/2012 combination and monotherapy arms were not evaluable for CDAI score outcome measure as CDAI score data were not available in medical records for any participant in TNFi initiators after 11/6/2012 combination and monotherapy arms.
Units on a scaleMEAN
SECONDARYCDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTXAt month 6 follow up visit
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Number Analyzed signifies number of participants evaluable for specified rows.
Units on a scaleMEAN
SECONDARYCDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi MonotherapyAt month 6 follow up visit
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Number Analyzed signifies number of participants evaluable for specified rows.
Units on a scaleMEAN
SECONDARYCDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTXAt month 6 follow up visit
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Number Analyzed signifies number of participants evaluable for specified rows.
Units on a scaleMEAN
SECONDARYCDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi MonotherapyAt month 6 follow up visit
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Number Analyzed signifies number of participants evaluable for specified rows.
Units on a scaleMEAN
SECONDARYNumber of Participants With Modified American College of Rheumatology 20% (mACR20) at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With MTXAt month 6 follow up visit
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall number of Participants Analyzed (N) signifies number of participants evaluable for this outcome measure.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With mACR20 at 6 Months for TNFi Monotherapy vs TNFi Combination With MTXAt month 6 follow up visit
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, N signifies number of participants evaluable for this outcome measure. Due to change in planned analysis, data for TNFi initiators after 11/6/2012 combination and monotherapy arms were not evaluable for mACR20 outcome measure as mACR20 data were not available in medical records for any participant in TNFi initiators after 11/6/2012 combination and monotherapy arms.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTXAt month 6 follow up visit
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi MonotherapyAt month 6 follow up visit
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTXAt month 6 follow up visit
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi MonotherapyAt month 6 follow up visit
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants According to Line of Therapy at TNFi InitiationAt baseline
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012At baseline
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants According to Line of Therapy at Tofacitinib InitiationAt baseline
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYMedian CDAI Score at Baseline- TNFi InitiatorAt baselineAnalysis population included all eligible participants whose medical records were retrieved and observed in this study.Units on a scaleMEDIAN
SECONDARYMedian CDAI Score at Baseline- Tofacitinib InitiatorAt baselineAnalysis population included all eligible participants whose medical records were retrieved and observed in this study.Units on a scaleMEDIAN
SECONDARYMedian CDAI Score at Baseline- TNFi Initiator After 11-6-2012At baselineAnalysis population included all eligible participants whose medical records were retrieved and observed in this study.Units on a scaleMEDIAN
SECONDARYNumber of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi InitiationAt baseline
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012At baseline
Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
ParticipantsCOUNT_OF_PARTICIPANTS

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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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