Trial Outcomes & Findings for Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease (NCT NCT00409617)
NCT ID: NCT00409617
Last Updated: 2011-10-10
Results Overview
5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Maximum total score for HBI is not specified, is dependent on number of diarrhea times each day and number of complications. Clinical remission = HBI less than 5. Highest total score at Baseline was 47. Missing data were imputed using non-responder imputation (NRI).
COMPLETED
PHASE3
945 participants
Week 20 of treatment
2011-10-10
Participant Flow
Participant milestones
| Measure |
Open Label Adalimumab 40 mg Every Other Week or Every Week
Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
|
|---|---|
|
Overall Study
STARTED
|
945
|
|
Overall Study
COMPLETED
|
785
|
|
Overall Study
NOT COMPLETED
|
160
|
Reasons for withdrawal
| Measure |
Open Label Adalimumab 40 mg Every Other Week or Every Week
Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
|
|---|---|
|
Overall Study
Adverse Event
|
57
|
|
Overall Study
Lack of Efficacy
|
54
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Protocol Violation
|
24
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Administrative reasons
|
1
|
|
Overall Study
Not described
|
14
|
Baseline Characteristics
Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
Baseline characteristics by cohort
| Measure |
Open Label Adalimumab 40 mg Every Other Week or Every Week
n=945 Participants
Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
|
|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
919 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age Continuous
|
35.3 years
STANDARD_DEVIATION 11.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
568 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
377 Participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia (Slovak Republic)
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
47 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
73 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
64 participants
n=5 Participants
|
|
Region of Enrollment
France
|
141 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
72 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
266 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 20 of treatmentPopulation: Intent-to-treat (ITT) population, defined as all participants who received at least 1 injection of adalimumab. Missing data were imputed using non-responder imputation; participants who discontinued the study prior to Week 20 and participants with no score on the Harvey-Bradshaw Index (missing value) at Week 20 were counted as "no" for remission.
5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Maximum total score for HBI is not specified, is dependent on number of diarrhea times each day and number of complications. Clinical remission = HBI less than 5. Highest total score at Baseline was 47. Missing data were imputed using non-responder imputation (NRI).
Outcome measures
| Measure |
Open Label Adalimumab 40 mg Every Other Week or Every Week
n=945 Participants
Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
|
|---|---|
|
Number of Participants in Clinical Remission at Treatment Week 20. Clinical Remission Defined as Harvey Bradshaw Index (HBI) Score Less Than 5.
|
492 Participants
4.26
|
SECONDARY outcome
Timeframe: Week 20 of treatmentPopulation: ITT Population, defined as all participants who received at least 1 injection of adalimumab. Missing data were imputed using non-responder imputation; participants who discontinued the study prior to Week 20 and participants with no score on the Harvey-Bradshaw Index (missing value) at Week 20 were counted as "no" for response.
5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Participants who had a decrease from Baseline of at least 3 points in HBI total score were considered responders. Missing data were imputed using non-responder imputation (NRI).
Outcome measures
| Measure |
Open Label Adalimumab 40 mg Every Other Week or Every Week
n=945 Participants
Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
|
|---|---|
|
Number of Participants Who Were Responders at Week 20 of Treatment. A Responder Was Defined as a Participant Who Had a Decrease of 3 or More on the HBI.
|
658 Participants
|
SECONDARY outcome
Timeframe: Week 20 of treatmentPopulation: 171 participants in the ITT population (participants who received at least 1 injection of adalimumab) had draining fistulas at baseline. Data were available for 148 of the 171 participants at Week 20 of treatment. Missing values were not imputed.
A count of the number of cutaneous fistulas draining was performed during each physical examination. Among participants who had draining fistulas at Baseline, the number of participants who had a reduction in the number of draining fistulas of at least 50% from Baseline to Week 20 of treatment was determined. Fistulas were classified as abdominal or perianal.
Outcome measures
| Measure |
Open Label Adalimumab 40 mg Every Other Week or Every Week
n=148 Participants
Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
|
|---|---|
|
Number of Participants Who Had a Reduction in Number of Draining Fistulas of at Least 50% From Baseline to Week 20
|
53 Participants
|
SECONDARY outcome
Timeframe: Week 20 of treatmentPopulation: 497 participants who received at least 1 injection of adalimumab (ITT population) had baseline EIM data. Missing data were imputed using non-responder imputation; participants who discontinued the study before Week 20 and participants with missing value at Week 20 were counted as "no" for resolution.
Number of participants who had EIM at baseline and had resolution of those manifestations at Week 20. EIM were skin lesions, eye lesions, joint complaints, CD-related hepatic disease, thrombosis, and nephrolithiasis. EIMs were determined by physical examination.
Outcome measures
| Measure |
Open Label Adalimumab 40 mg Every Other Week or Every Week
n=497 Participants
Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
|
|---|---|
|
Number of Participants Who Had Extra-intestinal Manifestations (EIM) at Baseline and Resolution by Week 20.
|
346 Participants
|
SECONDARY outcome
Timeframe: Week 20 of treatmentPopulation: The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. 907 participants had data available for calculating change in total score of SIBDQ. Missing values were imputed using LOCF.
10-item assessment of health-related quality of life (QoL) in patients with inflammatory bowel disease. Participant marks an option from 1 to 7 for each item. For some items, 1=None of the time; for other items, 1=All of the time. Value for all items are summed. Total score=10 to 70; a high score=good quality of life (QoL). An increase in score indicates improvement. An absolute change in the SIBDQ score of 9 is considered a minimum clinically important difference (MCID) for a patient.
Outcome measures
| Measure |
Open Label Adalimumab 40 mg Every Other Week or Every Week
n=907 Participants
Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
|
|---|---|
|
Mean Change in Total Score of Short Inflammatory Bowel Disease Questionnaire (SIBDQ) From Baseline to Week 20
|
13.2 Change in total score
Standard Deviation 13.39
|
SECONDARY outcome
Timeframe: Week 20 of treatmentPopulation: The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. 369 participants had data available for calculating change in Percent Work Time Missed. Missing values were imputed using LOCF.
Percent Work Time Missed (Absenteeism) due to CD is one component of the Work Productivity and Activity Impairment (WPAI) Questionnaire. Score of 0% = no impairment. A decrease in the mean indicates improvement.
Outcome measures
| Measure |
Open Label Adalimumab 40 mg Every Other Week or Every Week
n=369 Participants
Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
|
|---|---|
|
Mean Change in Percent Work Time Missed Due to Crohn's Disease From Baseline to Week 20 of Treatment
|
-10.8 Percent of work time missed
Standard Deviation 33.47
|
SECONDARY outcome
Timeframe: Week 20 of treatmentPopulation: The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. Data were available for 382 participants for the calculation of mean change in Percent Impairment While Working from Baseline to Week 20. Data were imputed using LOCF.
Percent impairment while working is a component of the Work Productivity and Activity Impairment measure. A score of 0% = no impairment. A decrease in mean score indicates lessening of impairment.
Outcome measures
| Measure |
Open Label Adalimumab 40 mg Every Other Week or Every Week
n=382 Participants
Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
|
|---|---|
|
Mean Change in Percent Impairment While Working From Baseline to Week 20 of Treatment
|
-20.0 Percent impairment at work
Standard Deviation 30.89
|
SECONDARY outcome
Timeframe: Week 20 of treatmentPopulation: The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. Data were available for 346 participants for the calculation of mean change in Overall Impairment from Baseline to Week 20. Data were imputed using LOCF.
6-items that assess impairment in work productivity and daily activity during the 7 days before the assessment. It measures the percentage of overall impairment in work productivity and daily activity due to CD. A WPAI score of 0% = no impairment and a score of 100% = total loss of work productivity or activity. An absolute change in WPAI score of 7% is considered the minimum clinically important difference (MCID).
Outcome measures
| Measure |
Open Label Adalimumab 40 mg Every Other Week or Every Week
n=346 Participants
Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
|
|---|---|
|
Mean Change in Overall Work Productivity and Activity Impairment Score From Baseline to Week 20
|
-21.8 Percent total impairment
Standard Deviation 34.29
|
SECONDARY outcome
Timeframe: Week 20 of treatmentPopulation: The ITT population, defined as participants who received at least 1 injection of adalimumab, was used. Data for 902 participants were available for calculating change from Baseline at Week 20 of treatment. Missing values were imputed by LOCF.
Daily activity is one component of the Work Productivity and Activity Impairment Questionnaire. 0% = no impairment. A decrease in the mean indicates improvement.
Outcome measures
| Measure |
Open Label Adalimumab 40 mg Every Other Week or Every Week
n=902 Participants
Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
|
|---|---|
|
Mean Change in Activity Impairment Score From Baseline to Week 20
|
-23.6 Percent activity impairment
Standard Deviation 30.58
|
Adverse Events
Open Label Adalimumab 40 mg Every Other Week or Every Week
Serious adverse events
| Measure |
Open Label Adalimumab 40 mg Every Other Week or Every Week
Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
|
|---|---|
|
Gastrointestinal disorders
CD
|
5.7%
54/945
|
|
Gastrointestinal disorders
Abdominal pain
|
0.85%
8/945
|
|
Infections and infestations
Perianal abscess
|
0.63%
6/945
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.53%
5/945
|
|
Gastrointestinal disorders
Subileus
|
0.53%
5/945
|
|
Gastrointestinal disorders
Vomiting
|
0.42%
4/945
|
|
Infections and infestations
Abdominal abscess
|
0.32%
3/945
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.32%
3/945
|
|
General disorders
Chest pain
|
0.32%
3/945
|
|
Psychiatric disorders
Depression
|
0.32%
3/945
|
|
Nervous system disorders
Dizziness
|
0.32%
3/945
|
|
Musculoskeletal and connective tissue disorders
Fistula discharge
|
0.32%
3/945
|
|
Infections and infestations
Herpes zoster
|
0.32%
3/945
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.32%
3/945
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.32%
3/945
|
|
General disorders
Pyrexia
|
0.32%
3/945
|
|
Blood and lymphatic system disorders
Anaemia
|
0.21%
2/945
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.11%
1/945
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.11%
1/945
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.11%
1/945
|
|
Cardiac disorders
Angina pectoris
|
0.11%
1/945
|
|
Cardiac disorders
Atrial fibrillation
|
0.11%
1/945
|
|
Cardiac disorders
Cardiovascular disorder
|
0.11%
1/945
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.11%
1/945
|
|
Gastrointestinal disorders
Anal fistula
|
0.11%
1/945
|
|
Gastrointestinal disorders
Anal skin tags
|
0.11%
1/945
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.21%
2/945
|
|
Gastrointestinal disorders
Diarrhoea
|
0.11%
1/945
|
|
Gastrointestinal disorders
Enteritis
|
0.11%
1/945
|
|
Gastrointestinal disorders
Enterocolonic fistula
|
0.11%
1/945
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.11%
1/945
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.11%
1/945
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.11%
1/945
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrrhage
|
0.11%
1/945
|
|
Gastrointestinal disorders
Ileitis
|
0.11%
1/945
|
|
Gastrointestinal disorders
Ileorectal fistula
|
0.11%
1/945
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.11%
1/945
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.11%
1/945
|
|
Gastrointestinal disorders
Intestinal functional disorder
|
0.11%
1/945
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.21%
2/945
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.11%
1/945
|
|
Gastrointestinal disorders
Nausea
|
0.21%
2/945
|
|
Gastrointestinal disorders
Pancreatitis
|
0.11%
1/945
|
|
Gastrointestinal disorders
Peritonitis
|
0.11%
1/945
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.11%
1/945
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.21%
2/945
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.21%
2/945
|
|
Gastrointestinal disorders
Asthenia
|
0.11%
1/945
|
|
General disorders
Disease progression
|
0.11%
1/945
|
|
General disorders
Influenza like illness
|
0.11%
1/945
|
|
General disorders
Malaise
|
0.11%
1/945
|
|
Hepatobiliary disorders
Biliary colic
|
0.11%
1/945
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.11%
1/945
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.11%
1/945
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.11%
1/945
|
|
Infections and infestations
Abdominal wall abscess
|
0.11%
1/945
|
|
Infections and infestations
Abscess
|
0.21%
2/945
|
|
Infections and infestations
Abscess intestinal
|
0.11%
1/945
|
|
Infections and infestations
Anogenital warts
|
0.11%
1/945
|
|
Infections and infestations
Bacterial infection
|
0.11%
1/945
|
|
Infections and infestations
Bronchiectasis
|
0.11%
1/945
|
|
Infections and infestations
Bronchitis
|
0.11%
1/945
|
|
Infections and infestations
Bronchopneumonia
|
0.11%
1/945
|
|
Infections and infestations
Campylobacter intestinal infection
|
0.11%
1/945
|
|
Infections and infestations
Clostridial infection
|
0.21%
2/945
|
|
Infections and infestations
Clostridium difficile colitis
|
0.11%
1/945
|
|
Infections and infestations
Diverticulitis
|
0.21%
2/945
|
|
Infections and infestations
Enteritis infectious
|
0.11%
1/945
|
|
Infections and infestations
Enterocolitis bacterial
|
0.11%
1/945
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.11%
1/945
|
|
Infections and infestations
Folliculitis
|
0.11%
1/945
|
|
Infections and infestations
Gastroenteritis
|
0.21%
2/945
|
|
Infections and infestations
Gastroenteritis viral
|
0.21%
2/945
|
|
Infections and infestations
Infection
|
0.11%
1/945
|
|
Infections and infestations
Klebsiella sepsis
|
0.11%
1/945
|
|
Infections and infestations
Oesophageal candidiasis
|
0.11%
1/945
|
|
Infections and infestations
Pelvic abscess
|
0.11%
1/945
|
|
Infections and infestations
Perineal abscess
|
0.11%
1/945
|
|
Infections and infestations
Perirectal abscess
|
0.11%
1/945
|
|
Infections and infestations
Pharyngitis
|
0.11%
1/945
|
|
Infections and infestations
Pneumonia
|
0.11%
1/945
|
|
Infections and infestations
Pseudomembranous colitis
|
0.11%
1/945
|
|
Infections and infestations
Pyelonephritis
|
0.11%
1/945
|
|
Infections and infestations
Rectal abscess
|
0.21%
2/945
|
|
Infections and infestations
Sepsis
|
0.11%
1/945
|
|
Infections and infestations
Urinary tract infection
|
0.11%
1/945
|
|
Infections and infestations
Viral infection
|
0.11%
1/945
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.11%
1/945
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.11%
1/945
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.11%
1/945
|
|
Investigations
Colonoscopy
|
0.11%
1/945
|
|
Investigations
Diagnostic procedure
|
0.11%
1/945
|
|
Investigations
Platelet count decreased
|
0.11%
1/945
|
|
Investigations
Tuberculin test positive
|
0.11%
1/945
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.11%
1/945
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.11%
1/945
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.21%
2/945
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.11%
1/945
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.11%
1/945
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.21%
2/945
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.11%
1/945
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.11%
1/945
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.11%
1/945
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.11%
1/945
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.11%
1/945
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.11%
1/945
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.11%
1/945
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular thyroid cancer
|
0.11%
1/945
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.11%
1/945
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.11%
1/945
|
|
Nervous system disorders
Benign intracranial hypertension
|
0.11%
1/945
|
|
Nervous system disorders
Demyelination
|
0.11%
1/945
|
|
Nervous system disorders
Headache
|
0.21%
2/945
|
|
Nervous system disorders
Hypoaesthesia
|
0.11%
1/945
|
|
Nervous system disorders
Lethargy
|
0.11%
1/945
|
|
Nervous system disorders
Neuralgic amyotrophy
|
0.11%
1/945
|
|
Nervous system disorders
Neuropathy peripheral
|
0.11%
1/945
|
|
Nervous system disorders
Syncope
|
0.11%
1/945
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.18%
1/568
|
|
Psychiatric disorders
Panic attack
|
0.11%
1/945
|
|
Psychiatric disorders
Suicide attempt
|
0.11%
1/945
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.11%
1/945
|
|
Renal and urinary disorders
Nephritis
|
0.11%
1/945
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.21%
2/945
|
|
Renal and urinary disorders
Renal colic
|
0.11%
1/945
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.18%
1/568
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.18%
1/568
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.18%
1/568
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.18%
1/568
|
|
Reproductive system and breast disorders
Ovarian hemorrhage
|
0.18%
1/568
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.11%
1/945
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.21%
2/945
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.11%
1/945
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.11%
1/945
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.11%
1/945
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.11%
1/945
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.11%
1/945
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.21%
2/945
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.11%
1/945
|
|
Vascular disorders
Thrombosis
|
0.11%
1/945
|
|
Surgical and medical procedures
Abortion induced
|
0.35%
2/568
|
|
Surgical and medical procedures
Intestinal anastomosis
|
0.11%
1/945
|
|
Surgical and medical procedures
Medical device removal
|
0.11%
1/945
|
|
Endocrine disorders
Adrenal insufficiency
|
0.11%
1/945
|
|
Infections and infestations
Anal abscess
|
0.21%
2/945
|
|
Infections and infestations
Influenza
|
0.11%
1/945
|
|
Infections and infestations
Vaginal infection
|
0.18%
1/568
|
Other adverse events
| Measure |
Open Label Adalimumab 40 mg Every Other Week or Every Week
Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.6%
62/945
|
|
Gastrointestinal disorders
Crohn's disease
|
5.9%
56/945
|
|
Gastrointestinal disorders
Nausea
|
7.6%
72/945
|
|
Infections and infestations
Nasopharyngitis
|
14.4%
136/945
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.6%
72/945
|
|
Nervous system disorders
Headache
|
18.9%
179/945
|
Additional Information
Global Medical Services
Abbott
Results disclosure agreements
- Principal investigator is a sponsor employee Provide ABBOTT at least thirty (30) days prior to submission for review, ABBOTT shall return comments promptly. Proposed draft shall be delayed an additional sixty (60) days in addition to the Review Period.
- Publication restrictions are in place
Restriction type: OTHER