CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 191 enrolled
Drug / intervention
PF-04236921 +1 morebiological
Likely dose
PF-04236921 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01345318
NCT01345318Phase 2Completed
CompareCT.gov

A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)

Pfizer·interventional·Posted May 2, 2011·Updated Jan 12, 2024

In Brief

A Phase 2 clinical trial evaluating PF-04236921 for Crohn's Disease. Completed, enrolled 191 participants across 127 sites in 16 countries.

Detailed Summary

This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustralia, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, New Zealand, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2, 2011
Enrollment StartJun 1, 2011
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 15.2 years ago

Interventions

PF-04236921biological

Subjects entering this study will be given a 50 mg SC dose at baseline and then every 8 weeks through Week 40.

PF-04236921biological

Dose escalation to 100 mg SC every 8 weeks will be allowed for subjects who have either not responded at Week 8 or have relapsed during the study.