Phase 3 N=514 Randomized Quadruple-blind Treatment

Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

Crohn's Disease

Bottom Line

View on ClinicalTrials.gov: NCT02065570 ↗

Enrolled (actual)

514

Serious AEs

4.9%

Results posted

Feb 2021

Primary outcome: Primary: Percentage of Participants Who Achieved Clinical Remission at Week 4 — 43.7; 43.5 percentage of participants — p=0.939

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Adalimumab (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AbbVie
Primary completion: Jan 2020

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

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.

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02065570). 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.