Phase 3
Completed N=514
Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease
Source: ClinicalTrials.gov NCT02065570 ↗Enrolled (actual)
514
Serious AEs
4.9%
Results posted
Feb 2021
Primary outcomePrimary: Percentage of Participants Who Achieved Clinical Remission at Week 4 — 43.7; 43.5 percentage of participants — p=0.939
◆ Published Evidence
Established
85citations · ~21 / year
Higher vs Standard Adalimumab Induction Dosing Regimens and Two Maintenance Strategies: Randomized SERENE CD Trial Results.
Summary
This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.
Linked Publications (5)
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Higher vs Standard Adalimumab Induction Dosing Regimens and Two Maintenance Strategies: Randomized SERENE CD Trial Results.
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Baseline TREM-1 Whole Blood Gene Expression Does Not Predict Response to Adalimumab Treatment in Patients with Ulcerative Colitis or Crohn's Disease in the SERENE Studies.
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HLA-DQA1*05 Associates With Anti-Tumor Necrosis Factor Immunogenicity and Low Adalimumab Trough Concentrations in Inflammatory Bowel Disease Patients From the SERENE Ulcerative Colitis and Crohn's Disease Studies.
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Assessing the Impact of Immunogenicity and Improving Prediction of Trough Concentrations: Population Pharmacokinetic Modeling of Adalimumab in Patients with Crohn's Disease and Ulcerative Colitis.
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Association of bile acid diarrhea with symptoms and disease activity in Crohn's disease: post-hoc clinical trial analysis of serum 7a-hydroxy-4cholestern-3-one, C4, in patients with active Crohn's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Clinical Remission at Week 4 |
43.7; 43.5 | 0.939 |
| PRIMARY Percentage of Participants With Endoscopic Response at Week 12 |
39.3; 42.9 | 0.462 |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
133; 185; 77; 76; 54; 75 | — |
| SECONDARY Percentage of Participants With Sustained Clinical Remission (Per CDAI) at Both Weeks 4 and 12 |
35.0; 39.0 | 0.269 |
| SECONDARY Percentage of Participants Who Achieve Clinical Response at Week 4 and Endoscopic Response at Week 12 |
20.4; 22.1 | 0.610 |
| SECONDARY Percentage of Participants With Clinical Remission at Week 12 |
51.5; 62.3 | 0.008 sig |
| SECONDARY Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 12 Among Participants Taking Corticosteroids at Baseline |
48.0; 52.9 | 0.336 |
| SECONDARY Percentage of Participants With Endoscopic Remission at Week 12 |
26.2; 28.6 | 0.694 |
| SECONDARY Change From Baseline in Fecal Calprotectin Level at Week 4 |
-1045.7; -1157.0 | 0.946 |
| SECONDARY Percentage of Participants With Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4 |
27.7; 32.5 | 0.293 |
| SECONDARY Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4 |
11.2; 14.3 | 0.304 |
| SECONDARY Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g and Endoscopic Remission at Week 12 |
7.3; 11.7 | 0.092 |
| SECONDARY Percentage of Participants Who Achieved an SES-CD ≤ 2 at Week 12 |
16.0; 20.1 | 0.278 |
| SECONDARY Percentage of Participants With Clinical Response at Week 4 |
70.9; 74.4 | 0.353 |
| SECONDARY Percentage of Participants With Clinical Response at Week 12 |
74.8; 83.4 | 0.015 sig |
| SECONDARY Percentage of Participants Achieving Response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain at Week 4 |
71.4; 74.7 | 0.394 |
| SECONDARY Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 12 |
73.3; 76.9 | 0.349 |
| SECONDARY Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 12 |
68.4; 76.0 | 0.054 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during the Screening Period.
- Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral corticosteroids and/or immunosuppressants.
- Mucosal ulceration on endoscopy.
Exclusion Criteria
- Subject with ulcerative colitis or indeterminate colitis.
- Subject who has had surgical bowel resections in the past 6 months or is planning resection.
- Subjects with an ostomy or ileoanal pouch.
- Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
- Subject who has short bowel syndrome.
- Chronic recurring infections or active Tuberculosis (TB).
Data sourced from ClinicalTrials.gov (NCT02065570) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.