Trial · NCT03464136
Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year
NCT03464136, Phase 3, Completed, Janssen Scientific Affairs, LLC; results first posted 2022-01-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year. Trials, record NCT03464136. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03464136
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year
- NCT number
- NCT03464136
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 386 participants, actual
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Conditions
- Crohn Disease
- Interventions
- Placebo for Ustekinumab, Placebo for Adalimumab, Ustekinumab (6 mg/kg), Ustekinumab (90 mg), Adalimumab (40 mg)
- First posted
- 2018-03-13
- Last updated
- 2025-04-29
- Other registries' IDs
- eudract:2017-004209-41
- Results first posted
- 2022-01-11
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Clinical Remission at Week 52 | Week 52 | Percentage of participants with clinical remission at Week 52 were assessed. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of less than (\<) 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. |
| Secondary | Percentage of Participants With Corticosteroid-free Remission at Week 52 | Week 52 | Percentage of participants with Corticosteroid-free remission at Week 52 were assessed. Corticosteroid-free remission was defined as CDAI score \<150 points at Week 52 and not taking any corticosteroids for at least 30 days prior to Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity. |
| Secondary | Percentage of Participants With Clinical Response at Week 52 | Week 52 | Percentage of participants with clinical response at Week 52 were assessed. Clinical response at Week 52 was defined as a reduction from baseline in the CDAI score of greater than or equal (\>=) 100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity. |
| Secondary | Percentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52 | Week 52 | PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools (total number of soft/liquid stools in the last 7 days) and abdominal pain (on a 4-point scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe). A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO-2 symptom remission was defined as an abdominal pain (AP) mean daily score at or below 1 and also stool frequency (SF) mean daily score at or below 3, that is, AP \<=1 and SF \<=3. PRO2 is a composite index consisting of weighted scoring of both variables. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease. |
| Secondary | Percentage of Participants With Clinical Remission at Week 16 | Week 16 | Percentage of participants with clinical remission (defined as CDAI \<150 points) at Week 16 were assessed. Clinical remission was defined as a CDAI score of \< 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. |
| Secondary | Percentage of Participants With Endoscopic Remission at Week 52 | Week 52 | Percentage of participants with endoscopic remission at Week 52 were assessed. Endoscopic remission was defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score less than or equal to (\<=) 3, or SES-CD =0 for participants who entered the study with a SES-CD =3 at Week 52. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis) each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. |
| Secondary | Percentage of Participants With Clinical Remission Through Week 52 | Weeks 2, 8, 16, 24, 32, 40, 48, and 52 | Percentage of participants with clinical remission at each postbaseline visit through Week 52 were reported. Clinical remission was defined as a CDAI score of \<150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. |
| Secondary | Percentage of Participants With Clinical Response Through Week 52 | Weeks 2, 8, 16, 24, 32, 40, 48, and 52 | Percentage of participants with clinical response at each postbaseline visit through Week 52 were reported. Clinical response through Week 52 was defined as a reduction from baseline in the CDAI score of \>=100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity. |
| Secondary | Percentage of Participants With Durable Clinical Response at Week 52 | Week 52 | Percentage of participants with durable clinical response at Week 52 were reported. Durable clinical response was defined as CDAI score decreased at least 100 from baseline or CDAI \<150 at Week 52 and was \>= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity. |
| Secondary | Percentage of Participants With Durable Clinical Remission at Week 52 | Week 52 | Percentage of participants with durable clinical remission at Week 52 were reported. Clinical remission was defined as CDAI score \<150 at Week 52 and was \>= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Clinical Remission at Week 52 | Week 52 | Full analysis set (FAS) which was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Corticosteroid-free Remission at Week 52 | Week 52 | FAS which was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response at Week 52 | Week 52 | FAS which was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52 | Week 52 | FAS which was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Remission at Week 16 | Week 16 | FAS which was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Endoscopic Remission at Week 52 | Week 52 | FAS among participants with SES-CD Score \>=3 at Baseline. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Remission Through Week 52 | Weeks 2, 8, 16, 24, 32, 40, 48, and 52 | FAS which was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response Through Week 52 | Weeks 2, 8, 16, 24, 32, 40, 48, and 52 | FAS which was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Durable Clinical Response at Week 52 | Week 52 | FAS which was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Durable Clinical Remission at Week 52 | Week 52 | FAS which was defined as all randomized participants. | percentage of participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Clinical Remission at Week 52 | Adalimumab | 61.0 | percentage of participants | ||
| Percentage of Participants With Clinical Remission at Week 52 | Ustekinumab | 64.9 | percentage of participants | ||
| Percentage of Participants With Corticosteroid-free Remission at Week 52 | Adalimumab | 57.4 | percentage of participants | ||
| Percentage of Participants With Corticosteroid-free Remission at Week 52 | Ustekinumab | 60.7 | percentage of participants | ||
| Percentage of Participants With Clinical Response at Week 52 | Adalimumab | 66.2 | percentage of participants | ||
| Percentage of Participants With Clinical Response at Week 52 | Ustekinumab | 72.3 | percentage of participants | ||
| Percentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52 | Adalimumab | 55.4 | percentage of participants | ||
| Percentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52 | Ustekinumab | 56.5 | percentage of participants | ||
| Percentage of Participants With Clinical Remission at Week 16 | Adalimumab | 60 | percentage of participants | ||
| Percentage of Participants With Clinical Remission at Week 16 | Ustekinumab | 57.1 | percentage of participants |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adalimumab | 195 | |
| Overall Study | STARTED | Ustekinumab | 191 | |
| Overall Study | COMPLETED | Adalimumab | 165 | |
| Overall Study | COMPLETED | Ustekinumab | 166 | |
| Overall Study | NOT COMPLETED | Adalimumab | 30 | |
| Overall Study | NOT COMPLETED | Ustekinumab | 25 |
Source ClinicalTrials.gov
Adverse events860
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 | Adalimumab | 7 | 195 | |
| other | Anaemia | Blood and lymphatic system disorders | Ustekinumab | 6 | 191 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Adalimumab | 1 | 195 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Ustekinumab | 1 | 191 | |
| other | Leukopenia | Blood and lymphatic system disorders | Adalimumab | 1 | 195 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ustekinumab | 1 | 191 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Adalimumab | 0 | 195 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Ustekinumab | 1 | 191 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Adalimumab | 1 | 195 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Ustekinumab | 1 | 191 |
1 to 10 of 860Source ClinicalTrials.gov
See all 860 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adalimumab | 1 | 195 |
| Total, all-cause mortality | Ustekinumab | 0 | 191 |
| Total, other adverse events | Adalimumab | 151 | 195 |
| Total, other adverse events | Ustekinumab | 152 | 191 |
| Total, serious adverse events | Adalimumab | 38 | 195 |
| Total, serious adverse events | Ustekinumab | 29 | 191 |
Source ClinicalTrials.gov
Papers3
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Adalimumab vs Ustekinumab: deaths from any cause | Trial comparisons |
| Adalimumab vs Ustekinumab: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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