Deze website met internetadres http://www.pfizerpro.nl en alle hierop vermelde informatie is uitsluitend gericht op inwoners van Nederland.
Menu
Close
Onderaan de pagina kunt u bijwerkingen melden.
Menu
Close
Trial Design
Baseline
Characteristics
Eligibility Criteria
Efficacy
Endpoints
ELEVATE UC 52 and ELEVATE UC 12 were randomized, multicenter, double-blind, placebo-controlled trials in patients 16 to 80 years of age with moderately to severely active UC1,2
Co-primary endpoints: Clinical remission at week 12 (ELEVATE UC 52 and ELEVATE UC 12) and week 52 (ELEVATE UC 52)2
Primary efficacy analysis was done in patients with a baseline mMS† of 5 to 9 (ELEVATE UC 52: n=409; ELEVATE UC 12: n=334)1,2
ELEVATE UC 52 used a treat-through trial design, which may more closely reflect clinical practice than a responder re-randomization trial.2,3
The treat-through trial design of ELEVATE UC 52 may more accurately represent clinical practice2,3
A treat-through trial reflects outcomes for all patients who started therapy, not just those who responded during induction3
Includes nonresponders and patients who respond late to treatment, representing real-world practice3,4
ELEVATE UC 52 (N=433) | ELEVATE UC 12 (N=354) | |
---|---|---|
Mean age | 40 years | 40 years |
Gender (female) | 45% | 41% |
Modified Mayo score (mMS) | ||
4 | 6% | 6% |
5-7 (moderate) | 67% | 67% |
>7 (severe) | 28% | 27% |
Biologic/JAK inhibitor (JAKi) exposure | ||
Biologic or JAKi naive | 70% | 67% |
Biologic or JAKi prior exposure | 30% | 33% |
>1 biologic or JAKi exposed | 14% | 18% |
Patients with isolated proctitis | 8% | 8% |
Concomitant treatment for UC at baseline | ||
Oral corticosteroids | 31% | 28% |
Oral aminosalicylates (5-ASAs) | 77% | 83% |
Patients 16 to 80 years of age with moderately to severely active ulcerative colitis (UC)* and a documented history of inadequate response, a loss of response, or an intolerance to ≥1 therapy approved for the treatment of UC†
Patients with isolated proctitis at baseline (<10 cm rectal involvement) who met other eligibility criteria could enroll in both trials, with enrollment capped at 15% of total patients‡
Patients were allowed to receive concomitant treatment for UC before trial screening, provided they were on:
Previous treatment with ≥3 biologics or ≥2 biologics + a JAK inhibitor
A high risk of requiring a colectomy in the next 3 months (per investigator)
A clinically relevant cardiac condition§
ELEVATE UC 52 | ELEVATE UC 12 | ||||
---|---|---|---|---|---|
Endpoints | Definitions | Week 12 | Week 52 | Week 12 | |
Primary endpoint | Clinical remission |
| ![]() | ![]() | ![]() |
Key secondary endpoints | Endoscopic improvement |
| ![]() | ![]() | ![]() |
Symptomatic remission |
| ||||
Histologic-endoscopic mucosal improvement |
| ||||
Corticosteroid-free clinical remission |
| N/A | ![]() | N/A | |
Sustained clinical remission |
| ||||
Other prespecified secondary endpoint | Clinical response |
| ![]() | ![]() | ![]() |
Read about clinical remission seen in patients on VELSIPITY.
Wilt u een bijwerking melden? Ga dan naar de 'Bijwerkingen melden' pagina en klik vervolgens op u van toepassing zijnde button.
De informatie die op deze website wordt aangeboden is uitsluitend bedoeld voor zorgverleners in Nederland. Bent u geen zorgverlener, maar patiënt of consument, ga dan naar www.pfizer.nl.
2025 Pfizer© Alle rechten voorbehouden.
Tab Number 5