RAPIDA: Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02148718
• Collaborator: Laboratorio Echevarne (Other), Pivotal S.L. (Industry)
• Enrollment: 100
• Arm: 1
• Actual Duration (Months): 31

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the rapidity of onset of clinical response to adalimumab therapy in patients with luminal Crohn's disease.

Condition or Disease	Intervention/Treatment	Phase
Moderate to Severe Crohn's Disease	Biological: adalimumab	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Rapidity of Onset of Response to Adalimumab in Luminal Crohn's Disease (RAPIDA Study)
• Actual Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adalimumab Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).	Biological: adalimumab; Adalimumab pre-filled syringe, administered by subcutaneous injection; Other Names: Humira, ABT-D2E7

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Clinical Response at Day 4 [Day 4]

   Clinical response defined as a decrease of at least 3 points in Harvey-Bradshaw Index (HBI) score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.

Secondary Outcome Measures

1. Percentage of Participants With Clinical Response at Week 1 [Week 1]

   Clinical response defined as a decrease of at least 3 points in HBI score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.

2. Percentage of Participants With Clinical Remission at Weeks 2 and 4 [Weeks 2 and 4]

   Clinical remission defined as HBI < 5. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.

3. European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Index Score: Change From Baseline to Week 12 [Baseline (Week 0) and Week 12]

   The EQ-5D-3L is a standardized instrument for use as a measure of health-related quality of life (HRQoL) and consists of 2 components: The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. The EQ-5D visual analog scale (VAS) is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively. A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L Index Score are presented.

4. European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Visual Analog Scale (VAS): Change From Baseline to Week 12 [Baseline (Week 0) and Week 12]

   The EQ-5D-3L is a standardized instrument for use as a measure of HRQoL and consists of 2 components: The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively. A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented.

5. Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12 [Baseline (Week 0) and Week 12]

   The IBDQ-36 is used to assess the HRQoL related to bowel symptoms. The IBDQ-36 overall score is calculated as the sum of thirty-six items, each scored on a 1 to 7 likert point scale, and ranges from 7 to 252. The highest score indicates the best HRQoL related to bowel symptoms. A positive change in IBDQ-36 overall score indicates an improvement in HRQoL due to inflammatory bowel disease. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented.

6. Fatigue Impact Scale for Daily Use (D-FIS): Change From Baseline to Week 12 [Baseline (Week 0) and Week 12]

   The D-FIS is used to measure the impact of fatigue on the daily lives of persons. The D-FIS overall score was calculated as the sum of eight items, each scored on a 0 to 4 point scale, and ranges from 0 to 32. A higher score indicates a higher impact of fatigue on daily life. A negative change in D-FIS Overall Score means an improvement in HRQoL due to fatigue. Mean Baseline and mean change from Baseline to Week 12 are presented.

7. Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hemoglobin [Baseline (Week 0) and Week 12]

   Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin, and coagulation (activated partial thromboplastin time [aPTT], international normalized ratio [INR], and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 are presented.

8. Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hematocrit [Baseline (Week 0) and Week 12]

   Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.

9. Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets [Baseline (Week 0) and Week 12]

   Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.

10. Change From Baseline to Week 12 in Analytic Markers of Inflammation: Erythrocytes [Baseline (Week 0) and Week 12]

    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.

11. Change From Baseline to Week 12 in Analytic Markers of Inflammation: Sedimentation Rate (ESR) [Baseline (Week 0) and Week 12]

    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.

12. Change From Baseline to Week 12 in Analytic Markers of Inflammation: C-reactive Protein (CRP) [Baseline (Week 0) and Week 12]

    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.

13. Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fecal Calprotectin [Baseline (Week 0) and Week 12]

    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.

14. Change From Baseline to Week 12 in Analytic Markers of Inflammation: Activated Partial Thromboplastin Time (aPTT) [Baseline (Week 0) and Week 12]

    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.

15. Change From Baseline to Week 12 in Analytic Markers of Inflammation: International Normalized Ratio (INR) [Baseline (Week 0) and Week 12]

    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.

16. Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fibrinogen [Baseline (Week 0) and Week 12]

    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.

17. Percentage of Participants With Clinical Response at Day 4 or Week 12 and Clinical Remission at Week 12 [Up to Week 12]

    The percentage of participants with clinical response (defined as decrease of at least 3 points in HBI score) at Day 4 or Week 1 and clinical remission (defined as a HBI < 5) at Week 12.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Crohn's disease (CD) diagnosed within, at least, the previous 4 months.

• Patients with active luminal (Harvey-Bradshaw Index [HBI] ≥ 8) moderate to- severe CD.

• No response to a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant.

• If receiving any of the following treatments, their dose should be stable during the periods indicated:

• Aminosalicylates for, at least, the last 4 weeks

• Probiotics for, at least, the last 4 weeks

• Analgesics for, at least, the last 4 weeks

• Antidiarrheals for, at least, the last 4 weeks

• CD-related antibiotics for, at least, the last 4 weeks

• Azathioprine, 6-mercaptopurine or methotrexate for, at least, the last 12 weeks

• If receiving any of the following treatments, their dose should not have been increase in the past two weeks (the dose reduction is permitted):

• Oral budesonide (maximum dose of 9 mg/day)

• Oral prednisone or equivalent (maximum dose of 40mg/day)

Exclusion Criteria:

• Previous treatment with any anti-Tumor Necrosis Factor agent

• Surgical bowel resection within the previous 6 months, ostomy, extensive bowel resection (> 100 cm), short bowel syndrome

• Fistulising Crohn's disease

• Treatment with cyclosporine or tacrolimus within the previous 8 weeks

• Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from screening, congestive heart failure of worse than grade II New York criteria (New York Heart Association Functional Classification).

• Subject with an ostomy or ileoanal pouch, proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis (Subjects with a previous ileo-rectal anastomosis are not excluded).

• Screening laboratory values (according to central laboratory)

• Known hepatitis C (HC) infection.

• Serologic evidence of hepatitis B (HB) infection based on the results of testing for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc) and hepatitis B surface antibody (anti-HBs) antibodies.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie
• Laboratorio Echevarne
• Pivotal S.L.

Investigators

• Principal Investigator: Ignacio Marín, PhD, Hospital General Universitario Gregorio Marañon

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related info.

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02148718
• Other Study ID Numbers: W13-984; 2013-004781-34
• First Posted: May 28, 2014
• Last Update Posted: Mar 1, 2018
• Last Verified: Feb 1, 2018

• Keywords provided by AbbVie: Crohn's Disease
• Additional relevant MeSH terms: Crohn Disease; Adalimumab

Study Results

Participant Flow

Pre-assignment Detail	A total of 100 participants were enrolled in the study; 14 participants did not receive study drug and are excluded from the analyses.

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Period Title: Overall Study
STARTED	86
COMPLETED	55
NOT COMPLETED	31

Baseline Characteristics

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Overall Participants	86
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.73 (12.16)
Sex: Female, Male (Count of Participants)
Female	49 57%
Male	37 43%
Region of Enrollment (participants) [Number]
Spain	86 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Clinical Response at Day 4
Description	Clinical response defined as a decrease of at least 3 points in Harvey-Bradshaw Index (HBI) score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.
Time Frame	Day 4

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	86
Number (95% Confidence Interval) [percentage of participants]	61.63 71.7%

2. Secondary Outcome

Title	Percentage of Participants With Clinical Response at Week 1
Description	Clinical response defined as a decrease of at least 3 points in HBI score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	86
Number (95% Confidence Interval) [percentage of participants]	75.58 87.9%

3. Secondary Outcome

Title	Percentage of Participants With Clinical Remission at Weeks 2 and 4
Description	Clinical remission defined as HBI < 5. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.
Time Frame	Weeks 2 and 4

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	86
Week 2	54.65 63.5%
Week 4	62.79 73%

4. Secondary Outcome

Title	European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Index Score: Change From Baseline to Week 12
Description	The EQ-5D-3L is a standardized instrument for use as a measure of health-related quality of life (HRQoL) and consists of 2 components: The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. The EQ-5D visual analog scale (VAS) is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively. A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L Index Score are presented.
Time Frame	Baseline (Week 0) and Week 12

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	82
Baseline	0.62 (0.22)
Change from Baseline to Week 12	0.14 (0.25)

5. Secondary Outcome

Title	European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Visual Analog Scale (VAS): Change From Baseline to Week 12
Description	The EQ-5D-3L is a standardized instrument for use as a measure of HRQoL and consists of 2 components: The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively. A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented.
Time Frame	Baseline (Week 0) and Week 12

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	82
Baseline	55.36 (18.52)
Change from Baseline to Week 12	15.37 (21.36)

6. Secondary Outcome

Title	Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12
Description	The IBDQ-36 is used to assess the HRQoL related to bowel symptoms. The IBDQ-36 overall score is calculated as the sum of thirty-six items, each scored on a 1 to 7 likert point scale, and ranges from 7 to 252. The highest score indicates the best HRQoL related to bowel symptoms. A positive change in IBDQ-36 overall score indicates an improvement in HRQoL due to inflammatory bowel disease. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented.
Time Frame	Baseline (Week 0) and Week 12

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	78
Baseline	145.1 (35.83)
Change from Baseline to Week 12	44.72 (37.98)

7. Secondary Outcome

Title	Fatigue Impact Scale for Daily Use (D-FIS): Change From Baseline to Week 12
Description	The D-FIS is used to measure the impact of fatigue on the daily lives of persons. The D-FIS overall score was calculated as the sum of eight items, each scored on a 0 to 4 point scale, and ranges from 0 to 32. A higher score indicates a higher impact of fatigue on daily life. A negative change in D-FIS Overall Score means an improvement in HRQoL due to fatigue. Mean Baseline and mean change from Baseline to Week 12 are presented.
Time Frame	Baseline (Week 0) and Week 12

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	79
Baseline	14.45 (8.53)
Change from Baseline to Week 12	-4.69 (8.44)

8. Secondary Outcome

Title	Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hemoglobin
Description	Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin, and coagulation (activated partial thromboplastin time [aPTT], international normalized ratio [INR], and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 are presented.
Time Frame	Baseline (Week 0) and Week 12

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	84
Baseline	13.01 (1.40)
Change from Baseline to Week 12	0.27 (0.97)

9. Secondary Outcome

Title	Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hematocrit
Description	Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Time Frame	Baseline (Week 0) and Week 12

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	84
Baseline	39.47 (3.99)
Change from Baseline to Week 12	0.86 (2.79)

10. Secondary Outcome

Title	Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
Description	Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Time Frame	Baseline (Week 0) and Week 12

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	84
Leukocytes Baseline	8.11 (3.23)
Leukocytes Change from Baseline to Week 12	-1.62 (2.87)
Neutrophils Baseline	5.61 (2.86)
Neutrophils Change from Baseline to Week 12	-1.99 (2.87)
Lymphocytes Baseline	1.80 (0.94)
Lymphocytes Change from Baseline to Week 12	0.39 (0.76)
Monocytes Baseline	0.50 (0.25)
Monocytes Change from Baseline to Week 12	-0.009 (0.219)
Eosinophils Baseline	0.17 (0.15)
Eosinophils Change from Baseline to Week 12	-0.010 (0.095)
Basophils Baseline	0.02 (0.02)
Basophils Change from Baseline to Week 12	0.003 (0.033)
Platelets Baseline	316.1 (90.1)
Platelets Change from Baseline to Week 12	-40.4 (76.4)

11. Secondary Outcome

Title	Change From Baseline to Week 12 in Analytic Markers of Inflammation: Erythrocytes
Description	Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Time Frame	Baseline (Week 0) and Week 12

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	84
Baseline	4.37 (0.51)
Change from Baseline to Week 12	0.052 (0.308)

12. Secondary Outcome

Title	Change From Baseline to Week 12 in Analytic Markers of Inflammation: Sedimentation Rate (ESR)
Description	Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Time Frame	Baseline (Week 0) and Week 12

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	84
Baseline	19.49 (18.38)
Change from Baseline to Week 12	-7.48 (14.26)

13. Secondary Outcome

Title	Change From Baseline to Week 12 in Analytic Markers of Inflammation: C-reactive Protein (CRP)
Description	Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Time Frame	Baseline (Week 0) and Week 12

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	85
Baseline	11.06 (16.2)
Change from Baseline to Week 12	-7.61 (16.4)

14. Secondary Outcome

Title	Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fecal Calprotectin
Description	Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Time Frame	Baseline (Week 0) and Week 12

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	74
Baseline	1,550.4 (2,798.4)
Change from Baseline to Week 12	-1,043.8 (2,895.3)

15. Secondary Outcome

Title	Change From Baseline to Week 12 in Analytic Markers of Inflammation: Activated Partial Thromboplastin Time (aPTT)
Description	Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Time Frame	Baseline (Week 0) and Week 12

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	85
Baseline	30.58 (3.89)
Change from Baseline to Week 12	0.76 (3.97)

16. Secondary Outcome

Title	Change From Baseline to Week 12 in Analytic Markers of Inflammation: International Normalized Ratio (INR)
Description	Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Time Frame	Baseline (Week 0) and Week 12

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	85
Baseline	1.05 (0.06)
Change from Baseline to Week 12	0.02 (0.07)

17. Secondary Outcome

Title	Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fibrinogen
Description	Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Time Frame	Baseline (Week 0) and Week 12

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	85
Baseline	374.5 (68.17)
Change from Baseline to Week 12	-43.6 (65.7)

18. Secondary Outcome

Title	Percentage of Participants With Clinical Response at Day 4 or Week 12 and Clinical Remission at Week 12
Description	The percentage of participants with clinical response (defined as decrease of at least 3 points in HBI score) at Day 4 or Week 1 and clinical remission (defined as a HBI < 5) at Week 12.
Time Frame	Up to Week 12

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
Measure Participants	86
Number [percentage of participants]	58.90 68.5%

Adverse Events

Time Frame	Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
Adverse Event Reporting Description	TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Arm/Group Title	Adalimumab
Arm/Group Description	Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
All Cause Mortality
	Adalimumab
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Adalimumab
	Affected / at Risk (%)	# Events
Total	2/86 (2.3%)
Gastrointestinal disorders
Crohn's disease	1/86 (1.2%)
General disorders
Pyrexia	1/86 (1.2%)
Infections and infestations
Pneumonia	1/86 (1.2%)
Other (Not Including Serious) Adverse Events
	Adalimumab
	Affected / at Risk (%)	# Events
Total	35/86 (40.7%)
Blood and lymphatic system disorders
Anaemia	1/86 (1.2%)
Ear and labyrinth disorders
Ear pain	1/86 (1.2%)
Eye disorders
Eyelid disorder	1/86 (1.2%)
Lacrimation increased	1/86 (1.2%)
Presbyopia	1/86 (1.2%)
Gastrointestinal disorders
Abdominal mass	5/86 (5.8%)
Abdominal pain	3/86 (3.5%)
Aphthous ulcer	2/86 (2.3%)
Crohn's disease	1/86 (1.2%)
Diarrhoea	3/86 (3.5%)
Haemorrhoids	1/86 (1.2%)
Subileus	1/86 (1.2%)
Vomiting	6/86 (7%)
General disorders
Asthenia	2/86 (2.3%)
Fatigue	1/86 (1.2%)
General physical health deterioration	1/86 (1.2%)
Pyrexia	2/86 (2.3%)
Immune system disorders
Drug hypersensitivity	1/86 (1.2%)
Infections and infestations
Cellulitis	1/86 (1.2%)
Conjunctivitis	1/86 (1.2%)
Folliculitis	1/86 (1.2%)
Herpes virus infection	3/86 (3.5%)
Influenza	4/86 (4.7%)
Nasopharyngitis	1/86 (1.2%)
Pharyngitis	3/86 (3.5%)
Pharyngotonsillitis	1/86 (1.2%)
Rash pustular	1/86 (1.2%)
Respiratory tract infection	2/86 (2.3%)
Rotavirus infection	1/86 (1.2%)
Tooth infection	1/86 (1.2%)
Urinary tract infection	3/86 (3.5%)
Investigations
Blood triglycerides increased	1/86 (1.2%)
Transaminases increased	1/86 (1.2%)
Weight decreased	1/86 (1.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	4/86 (4.7%)
Arthritis	1/86 (1.2%)
Flank pain	1/86 (1.2%)
Muscular weakness	1/86 (1.2%)
Sacroiliitis	1/86 (1.2%)
Nervous system disorders
Headache	1/86 (1.2%)
Migraine	1/86 (1.2%)
Psychiatric disorders
Anxiety	1/86 (1.2%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	1/86 (1.2%)
Skin and subcutaneous tissue disorders
Alopecia	2/86 (2.3%)
Eczema	1/86 (1.2%)
Erythema	1/86 (1.2%)
Psoriasis	4/86 (4.7%)
Rash	2/86 (2.3%)
Skin lesion	1/86 (1.2%)
Vascular disorders
Hypertension	1/86 (1.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.