A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting

Résumé

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission). Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab. During the study, participants will visit their study clinic several times.

Éligibilité

Conception de l'étude

Critères de jugement

1. Critère de jugement principal

   Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14

   PRO-2 remission is defined as 7-day average of very soft or liquid stool frequency (SF) less than and equal to (\<=) 2.8, 7-day average of abdominal pain (AP) score \<= 1.0, and neither worse than baseline.

   Délai At Week 14

2. Critère de jugement principal

   Percentage of UC Participants With PRO-2 Remission at Week 14

   PRO-2 remission is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1.

   Délai At Week 14

3. Critère de jugement secondaire

   Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52

   PRO-2 remission for CD participants is defined as 7-day average of very soft or liquid SF \<= 2.8, 7-day average of AP score \<= 1.0, and neither worse than baseline. PRO-2 remission for UC participants is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1.

   Délai At Weeks 6 and 52

4. Critère de jugement secondaire

   Percentage of CD and UC Participants With Clinical Response at Weeks 6, 14, and 52

   CD clinical response is defined as greater than and equal to (\>=) 100 points decrease from baseline in CDAI score. UC clinical response is defined as reduction in complete Mayo score of \>=3 points and \>=30 percent (%) from baseline with an accompanying decrease in rectal bleeding sub-score of \>=1 point or absolute rectal bleeding sub-score of \<=1 point or an absolute rectal bleeding sub-score of \<=1 point, or a reduction in partial Mayo score of \>=2 points and \>=25% from baseline, if complete Mayo score was not performed at visit.

   Délai At Weeks 6, 14, and 52

5. Critère de jugement secondaire

   Percentage of CD Participants With Endoscopic Response at Week 52

   Endoscopic response is defined as a \>=50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 endoscopic variables: the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing.

   Délai At Week 52

6. Critère de jugement secondaire

   Percentage of CD Participants Achieving Endoscopic Remission at Week 52

   Endoscopic remission as per SES-CD is defined as a SES-CD score of 0 to 4, with no individual sub-score greater than 1. SES-CD evaluates 4 endoscopic variables: the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing.

   Délai At Week 52

7. Critère de jugement secondaire

   Percentage of UC Participants With Improvement of Endoscopic Appearance of the Mucosa at Week 52

   Improvement of endoscopic appearance of the mucosa is defined as Modified Mayo endoscopic sub-score (MMES) of 0 or 1.

   Délai At Week 52

8. Critère de jugement secondaire

   Percentage of UC Participants With Endoscopic Remission at Week 52

   Endoscopic remission is defined as a centrally read complete Mayo endoscopy sub-score of 0.

   Délai At Week 52

9. Critère de jugement secondaire

   Percentage of CD and UC Participants With Clinical Remission at Weeks 6, 14, and 52

   Clinical Remission for CD is defined as a CDAI \<150 point. Clinical remission for UC is defined as complete MS of \<=2 points and no participant sub-score greater than (\>) 1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, physician's global assessment \[PGA\]) score of \<=2 and no individual sub-score \>1.

   Délai At Weeks 6, 14, and 52

10. Critère de jugement secondaire

    Percentage of CD and UC Participants With Clinical Remission at Week 52

    Clinical remission for CD is defined as a CDAI \<150 point. Clinical remission for UC is defined as complete MS of \<=2 points and no participant sub-score \>1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, PGA) score of \<=2 and no individual sub-score \>1. Percentage of CD and UC participants with clinical remission at Week 52, among those participants who achieved clinical remission at Week 6 and 14 will be reported.

    Délai At Week 52

11. Critère de jugement secondaire

    Change From Baseline in C-reactive Protein (CRP) levels of CD and UC Participants at Weeks 6, 14, 26, and 52

    Change from baseline in CRP levels of CD and UC participants at Weeks 6, 14, 26, and 52 will be reported.

    Délai Baseline, Weeks 6, 14, 26, and 52

12. Critère de jugement secondaire

    Change From Baseline in Fecal Calprotectin Concentrations of CD and UC participants at Weeks 6, 14, and 52

    Change from baseline in fecal calprotectin concentrations of CD and UC participants at Weeks 6, 14, and 52 will be reported.

    Délai Baseline, Weeks 6, 14, and 52

13. Critère de jugement secondaire

    Percentage of CD and UC Participants With Serious Infections

    Percentage of CD and UC participants with serious infections will be reported.

    Délai Up to end of study (up to 72 weeks)

Dates

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

78 sites sont en recrutement

51 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

1. 15 septembre 2026

   Date d'achèvement avancée

   Primary completion advanced 153 days

   2027-10-01 → 2027-05-01

2. 15 septembre 2026

   Objectif de recrutement modifié

   Enrollment target revised down from 400 to 200

   400 → 200