# A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)

> **NCT01369355** · PHASE3 · COMPLETED · sponsor: **Janssen Research & Development, LLC** · enrollment: 1282 (actual)

## Conditions studied

- Crohn's Disease
- Colitis
- IBD
- Inflammatory Bowel Disease

## Interventions

- **DRUG:** Placebo SC
- **DRUG:** Placebo IV
- **DRUG:** Ustekinumab 90 mg SC q8w
- **DRUG:** Ustekinumab 130 mg IV
- **DRUG:** Ustekinumab 90 mg SC q12w

## Key facts

- **NCT ID:** NCT01369355
- **Lead sponsor:** Janssen Research & Development, LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-09-13
- **Primary completion:** 2015-06-10
- **Final completion:** 2019-10-01
- **Target enrollment:** 1282 (ACTUAL)
- **Last updated:** 2025-02-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01369355

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01369355, "A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT01369355. Licensed CC0.

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