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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
514
Percentage of Participants Who Achieved Clinical Remission at Week 4
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 4
Percentage of Participants With Endoscopic Response at Week 12
Endoscopic response was scored using the Simplified Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 \[none\] to 3 \[very large\]; ulcerated surface ranging from 0 \[none\] to 3 \[\>30%\]; affected surface ranging from 0 \[none\] to 3 \[\>75%\], and narrowing ranging from 0 \[none\] to 3 \[cannot be passed\]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD total score \> 50% from Baseline (or for a Baseline SES-CD of 4, at least a 2 point reduction from Baseline) at Week 12.
Time frame: Week 12
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Adverse event (AE): any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. Serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. TEAEs: any event that began or worsened in severity after the first dose of study drug in the induction or maintenance study. Events with unknown severity were counted as severe. Events with unknown relationship to study drug were counted as drug-related.
Time frame: From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).
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Birmingham Gastroenterology Associates O.C /ID# 137282
Birmingham, Alabama, United States
Digestive Health Specialists of the Southeast /ID# 122483
Dothan, Alabama, United States
Moore UC San Diego Cancer Center /ID# 119053
La Jolla, California, United States
Axis Clinical Trials /ID# 130390
Los Angeles, California, United States
Rocky Mountain Gastroenterology /ID# 119038
Wheat Ridge, Colorado, United States
Medical Research Ctr CT /ID# 119037
Hamden, Connecticut, United States
Gastroenterology Group Naples /ID# 122493
Naples, Florida, United States
Internal Med Specialists /ID# 137737
Orlando, Florida, United States
Shafran Gastroenterology Ctr /ID# 119057
Winter Park, Florida, United States
Winship Cancer Institute of Emory University /ID# 136851
Atlanta, Georgia, United States
...and 133 more locations
Percentage of Participants With Sustained Clinical Remission (Per CDAI) at Both Weeks 4 and 12
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 4 and Week 12
Percentage of Participants Who Achieve Clinical Response at Week 4 and Endoscopic Response at Week 12
Clinical response was scored using CDAI, which assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. Clinical response was defined as a decrease in CDAI ≥ 70 points from Baseline. Endoscopic response was scored using the SES-CD, which evaluates 4 endoscopic variables (ulcer size ranging from 0 \[none\] to 3 \[very large\]; ulcerated surface ranging from 0 \[none\] to 3 \[\>30%\]; affected surface ranging from 0 \[none\] to 3 \[\>75%\], and narrowing ranging from 0 \[none\] to 3 \[cannot be passed\]) in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD total score \>50% from Baseline (or for Baseline SES-CD of 4, at least a 2-point reduction from Baseline) at Week 12.
Time frame: Week 12
Percentage of Participants With Clinical Remission at Week 12
Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 12
Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 12 Among Participants Taking Corticosteroids at Baseline
Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 12
Percentage of Participants With Endoscopic Remission at Week 12
Endoscopic remission was scored using the SES-CD.The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 \[none\] to 3 \[very large\]; ulcerated surface ranging from 0 \[none\] to 3 \[\>30%\]; affected surface ranging from 0 \[none\] to 3 \[\>75%\], and narrowing ranging from 0 \[none\] to 3 \[cannot be passed\]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic remission was defined as SES-CD ≤ 4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable.
Time frame: Week 12
Change From Baseline in Fecal Calprotectin Level at Week 4
Time frame: Baseline, Week 4
Percentage of Participants With Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4
Time frame: Week 4
Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4
Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 4
Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g and Endoscopic Remission at Week 12
Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. Endoscopic remission was scored using the SES-CD.The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 \[none\] to 3 \[very large\]; ulcerated surface ranging from 0 \[none\] to 3 \[\>30%\]; affected surface ranging from 0 \[none\] to 3 \[\>75%\], and narrowing ranging from 0 \[none\] to 3 \[cannot be passed\]) in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic remission was defined as SES-CD ≤ 4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable.
Time frame: Week 12
Percentage of Participants Who Achieved an SES-CD ≤ 2 at Week 12
The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 \[none\] to 3 \[very large\]; ulcerated surface ranging from 0 \[none\] to 3 \[\>30%\]; affected surface ranging from 0 \[none\] to 3 \[\>75%\], and narrowing ranging from 0 \[none\] to 3 \[cannot be passed\]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease.
Time frame: Week 12
Percentage of Participants With Clinical Response at Week 4
Clinical response was scored using CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. Clinical response was defined as a decrease in CDAI ≥ 70 points from baseline.
Time frame: Week 4
Percentage of Participants With Clinical Response at Week 12
Clinical response was scored using CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. Clinical response was defined as a decrease in CDAI ≥ 70 points from Baseline.
Time frame: Week 12
Percentage of Participants Achieving Response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain at Week 4
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score ≥ 8.
Time frame: Week 4
Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 12
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score ≥ 8.
Time frame: Week 12
Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 12
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The IBDQ Fatigue item score range is from 1 (severe problem) to 7 (normal health). Response is defined as an increase of IBDQ Fatigue item score ≥ 1.
Time frame: Week 12