Trial · 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)
NCT01369355, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2017-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI). Trials, record NCT01369355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01369355
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)
- NCT number
- NCT01369355
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,282 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Crohn's Disease, Colitis, IBD, Inflammatory Bowel Disease
- Interventions
- Placebo SC, Placebo IV, Ustekinumab 90 mg SC q8w, Ustekinumab 130 mg IV, Ustekinumab 90 mg SC q12w
- First posted
- 2011-06-08
- Last updated
- 2025-02-04
- Other registries' IDs
- eudract:2010-022760-12
- Results first posted
- 2017-02-23
- Limitations and caveats
- The global study was interrupted due to issues with the clinical supply.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Remission at Week 44 | Week 44 | Clinical remission at Week 44 was defined as a Crohn's Disease Activity Index (CDAI) score of \<150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). A decrease in CDAI over time indicates improvement in disease activity. |
| Secondary | Number of Participants With Clinical Response at Week 44 | Week 44 | Clinical response at Week 44 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (\>=) 100 points. Participants with a baseline CDAI score of \> = 220 to less than or equal (\< =) 248 were considered to be in clinical response if a CDAI score of less than (\<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity. |
| Secondary | Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study | Week 44 | Clinical remission at week 44 was defined as a CDAI score of \< 150 points among participants in clinical remission to ustekinumab at week 0 of maintenance study. |
| Secondary | Number of Participants With Corticosteroid-free Remission at Week 44 | Week 44 | Corticosteroid-free remission at Week 44 was defined as a CDAI score of \<150 points without receiving corticosteroids at Week 44. |
| Secondary | Number of Participants in Clinical Remission at Week 44 in the Subset of Participants Who Were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy | Week 44 | Clinical remission at Week 44 was defined as a CDAI score of \<150 points in the subset of participants who were refractory or Intolerant to tumor necrosis factor antagonist therapy. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinical Remission at Week 44 | Week 44 | The primary efficacy analysis population in this study was randomized participants (i.e., participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart. | participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Response at Week 44 | Week 44 | The primary efficacy analysis population in this study was randomized participants (i.e., participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart. | participants | NUMBER |
| SECONDARY | Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study | Week 44 | Analysis population included all randomized participants after the study was restarted (who were in clinical remission at Week 0 of maintenance study). 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | participants | NUMBER |
| SECONDARY | Number of Participants With Corticosteroid-free Remission at Week 44 | Week 44 | The primary efficacy analysis population in this study was randomized participants (i.e., participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart. | participants | NUMBER |
| SECONDARY | Number of Participants in Clinical Remission at Week 44 in the Subset of Participants Who Were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy | Week 44 | The primary efficacy analysis population in this study was randomized participants (i.e., participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinical Remission at Week 44 | Placebo Subcutaneously (SC) | 47 | participants | ||
| Number of Participants With Clinical Remission at Week 44 | Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w) | 63 | participants | ||
| Number of Participants With Clinical Remission at Week 44 | Ustekinumab 90 mg SC q8w | 68 | participants | ||
| Number of Participants With Clinical Response at Week 44 | Placebo Subcutaneously (SC) | 58 | participants | ||
| Number of Participants With Clinical Response at Week 44 | Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w) | 75 | participants | ||
| Number of Participants With Clinical Response at Week 44 | Ustekinumab 90 mg SC q8w | 76 | participants | ||
| Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study | Placebo Subcutaneously (SC) | 36 | participants | ||
| Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study | Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w) | 44 | participants | ||
| Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study | Ustekinumab 90 mg SC q8w | 52 | participants | ||
| Number of Participants With Corticosteroid-free Remission at Week 44 | Placebo Subcutaneously (SC) | 39 | participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Week 0 - Week 44 (Maintenance) | STARTED | Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance | 133 | |
| Week 0 - Week 44 (Maintenance) | STARTED | UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance | 132 | |
| Week 0 - Week 44 (Maintenance) | STARTED | UST-I-Rsp-UST-90 mg Q8W Maintenance | 132 | |
| Week 0 - Week 44 (Maintenance) | STARTED | Placebo (PBO)-I-Rsp - PBO Maintenance | 123 | |
| Week 0 - Week 44 (Maintenance) | STARTED | PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance | 285 | |
| Week 0 - Week 44 (Maintenance) | STARTED | UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance | 476 | |
| Week 0 - Week 44 (Maintenance) | STARTED | Placebo Long Term Extension (LTE) | 0 | |
| Week 0 - Week 44 (Maintenance) | STARTED | UST 90 mg SC Q12W LTE | 0 | |
| Week 0 - Week 44 (Maintenance) | STARTED | UST 90 mg SC Q8W LTE | 0 | |
| Week 0 - Week 44 (Maintenance) | COMPLETED | Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance | 102 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events3,192
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Ustekinumab Induction Responders(USTIRsp) Placebo Maintenance | 0 | 133 | |
| other | Anaemia | Blood and lymphatic system disorders | UST -I-Rsp -PBO Maintenance -UST-90mg SC Q8W- Maintenance | 0 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | UST-I-Rsp-UST 90 mg SC Every 12 Weeks (Q12W) Maintenance | 5 | 132 | |
| other | Anaemia | Blood and lymphatic system disorders | UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance | 1 | 29 | |
| other | Anaemia | Blood and lymphatic system disorders | UST-I-Rsp-UST 90 mg SC Q8W Maintenance | 3 | 131 | |
| other | Anaemia | Blood and lymphatic system disorders | UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance | 0 | 29 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo (PBO)-I-Rsp PBO Maintenance | 5 | 123 | |
| other | Anaemia | Blood and lymphatic system disorders | PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance | 6 | 285 | |
| other | Anaemia | Blood and lymphatic system disorders | UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance | 11 | 476 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Long Term Extension (LTE) | 2 | 151 |
1 to 10 of 3,192Source ClinicalTrials.gov
See all 3,192 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ustekinumab Induction Responders(USTIRsp) Placebo Maintenance | 0 | 133 |
| Total, all-cause mortality | UST -I-Rsp -PBO Maintenance -UST-90mg SC Q8W- Maintenance | 0 | 51 |
| Total, all-cause mortality | UST-I-Rsp-UST 90 mg SC Every 12 Weeks (Q12W) Maintenance | 0 | 132 |
| Total, all-cause mortality | UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance | 0 | 29 |
| Total, all-cause mortality | UST-I-Rsp-UST 90 mg SC Q8W Maintenance | 0 | 131 |
| Total, all-cause mortality | UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance | 0 | 29 |
| Total, all-cause mortality | Placebo (PBO)-I-Rsp PBO Maintenance | 0 | 123 |
| Total, all-cause mortality | PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance | 0 | 285 |
| Total, all-cause mortality | UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance | 0 | 476 |
| Total, all-cause mortality | Placebo Long Term Extension (LTE) | 0 | 151 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers17
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
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