Trial · NCT03649971
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change from Baseline in Rectal/pouch Polyp Burden at Week 24 | Baseline, Week 24 | Percentage change from baseline in rectal/pouch polyp burden (sum of the polyp diameters) at Week 24 will be determined through endoscopy. |
| Secondary | Percentage Change from Baseline in Number of Colorectal Polyps | Baseline, Weeks 24 and 52 | Percentage change from baseline in number of colorectal polyps will be determined. |
| Secondary | Percentage Change from Baseline in Number of J-pouch Polyps | Baseline, Weeks 24 and 52 | Percentage change from baseline in number of J-pouch polyps will be determined. |
| Secondary | Percentage Change from Baseline in J-pouch Polyp Burden | Baseline, Weeks 24 and 52 | Percentage change from baseline in J-pouch polyp burden (sum of polyp diameters) will be determined. |
| Secondary | Percentage Change from Baseline in Number of Duodenal Polyps | Baseline, Weeks 24 and 52 | Percentage change from baseline in number of duodenal polyps will be determined. |
| Secondary | Percentage Change from Baseline in Duodenal Polyp Burden | Baseline, Weeks 24 and 52 | Percentage change from baseline in duodenal polyp burden (sum of polyp diameters) will be determined. |
| Secondary | Change in International Society for Gastrointestinal Hereditary Tumors (InSiGHT) Stage | Baseline, Weeks 24 and 52 | Change in InSiGHT stage will be determined. Various stages of InSiGHT staging system are defined as: Stage 0: 0-10 polyps, all less than (\<)5 millimeter (mm); Stage 1: 10-25 polyps, most \< 5 mm, none greater than (\>) 1 centimeter (cm); Stage 2: 10-25 polyps, any \> 1 cm, amenable to complete removal; Stage 3: \> 25 polyps amenable to complete removal, or any incompletely removed sessile polyp, or any evidence of High-Grade Dysplasia (HGD), even if completely excised; and Stage 4: \> 25 polyps amenable to complete removal, or any incompletely excised sessile polyp showing HGD, any invasive cancer). |
| Secondary | Change in Spigelman Stage Score | Baseline, Weeks 24 and 52 | Change in Spigelman stage score will be determined. Spigelman classification system measures risk of developing duodenal cancer in familial adenomatous polyposis (FAP). It has been classified in following stages- Stage 0 (0 points); Stage 1 (1-4 points); Stage 2 (5-6 points); Stage 3 (7-8 points); and Stage 4 (9-12 points). The total score ranges from 0 to 12. Points are accumulated for polyps' number, size, histology and severity of dysplasia. Stage 1 indicates mild disease, whereas stage 3-4 indicates severe duodenal polyposis. |
| Secondary | Trough Concentration of Guselkumab | Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, and 48 | Serum samples will be analyzed to determine trough concentrations of guselkumab using a validated specific, and sensitive method. |
| Secondary | Number of Participants with Anti-guselkumab Antibodies | Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, and 48 | Number of participants with Anti-guselkumab antibodies will be determined. |
| Secondary | Anti-guselkumab Antibodies Serum Titers | Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, and 48 | Serum samples will be screened for antibodies binding to guselkumab and the titer of confirmed positive samples will be reported. |
| Secondary | Number of Participants with Adverse Events as a Measure of Safety | From Screening up to 60 Weeks | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Secondary | Number of Participants with Vital Sign Abnormalities as a Measure of Safety and Tolerability | From Screening up to 52 Weeks | Number of participants with vital sign abnormalities will be reported. Vital signs includes temperature, pulse/heart rate, respiratory rate and blood pressure. |
| Secondary | Number of Participants with Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability | From Screening up to 52 Weeks | Number of participants with clinical laboratory abnormalities will be reported. Blood samples for serum chemistry and hematology will be collected at predefined time points for clinical laboratory testing. |
| Secondary | Relative Changes to Baseline in Levels of Interleukin (IL)-23 Effector Proteins in Biopsy Tissue | Baseline, Weeks 12, 24, and 52 | Relative Changes to Baseline in levels of IL-23 effector proteins in biopsy tissue will be measured. |
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.
For software
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