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Trial · NCT05431283

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primaryjoint response and steroid free joint responseweek 8evaluate the rate of patients achieving joint response and steroid free joint response on Ulcerative Colitis-associated spondyloarthropathy at week 8, 24, and 52
Primaryjoint response and steroid free joint responseweek 24evaluate the rate of patients achieving joint response on Ulcerative Colitis-associated spondyloarthropathy
Primaryjoint response and steroid free joint responseweek 52evaluate the rate of patients achieving joint response and steroid free joint response on Ulcerative Colitis-associated spondyloarthropathy
Secondaryclinical intestinal response CIRweek 8To assess the rate of patients achieving a clinical intestinal response CIR for Ulcerative Colitis
Secondaryclinical intestinal response CIRweek 24To assess the rate of patients achieving a clinical intestinal response CIR for Ulcerative Colitis
Secondaryclinical intestinal response CIRweek 52To assess the rate of patients achieving a clinical intestinal response CIR for Ulcerative Colitis
Secondarysteroid free clinical intestinal remissionweek 52To assess the rate of patients achieving a steroid free clinical intestinal remission for Ulcerative Colitis
Secondaryimpact of Ulcerative Colitisweek 8To assess the impact of Ulcerative Colitis and therapy with TOFA on Work Productivity and Activity Impairment through the administration of WPAI Questionnaire at baseline
Secondaryimpact of Ulcerative Colitisweek 24To assess the impact of Ulcerative Colitis and therapy with TOFA on Work Productivity and Activity Impairment through the administration of WPAI Questionnaire at baseline
Secondaryimpact of Ulcerative Colitisweek 52To assess the impact of Ulcerative Colitis and therapy with TOFA on Work Productivity and Activity Impairment through the administration of WPAI Questionnaire at baseline
Secondaryhealth-related quality of lifeweek 24 and 52To assess the health-related quality of life of the patients with the administration of the Short IBDQ at baseline
Secondaryhealth-related quality of lifeweek 52To assess the health-related quality of life of the patients with the administration of the Short IBDQ at baseline
Secondaryadverse events24 monthTo report the rate of adverse events with TOFA
Secondaryredictors of joint response JR, steroid free joint response SFJR, clinical intestinal response CIR, and steroid free clinical intestinal remission SFCIR24 monthTo assess the predictors of joint response JR, steroid free joint response SFJR, clinical intestinal response CIR, and steroid free clinical intestinal remission SFCIR

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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