Trial Outcomes & Findings for Reveal the Level of Anxiety in Patients With Crohn's Disease Receiving Adalimumab (NCT NCT01428115)
NCT ID: NCT01428115
Last Updated: 2014-11-03
Results Overview
The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.
COMPLETED
83 participants
Baseline and Visit 3 [Month 6]
2014-11-03
Participant Flow
Participant milestones
| Measure |
Adalimumab
Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
|
|---|---|
|
Overall Study
STARTED
|
83
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
Adalimumab
Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
|
|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Lost to Follow-up
|
10
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Reveal the Level of Anxiety in Patients With Crohn's Disease Receiving Adalimumab
Baseline characteristics by cohort
| Measure |
Adalimumab
n=83 Participants
Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
|
|---|---|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
|
Participants with Comorbidities
Yes
|
18 participants
n=99 Participants
|
|
Participants with Comorbidities
No
|
65 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and Visit 3 [Month 6]Population: All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.
The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.
Outcome measures
| Measure |
Adalimumab
n=59 Participants
Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change in State Trait Anxiety Index (STAI) State Scores From Baseline to After 6 Months of Treatment With Adalimumab
|
-1.7 scores on a scale
Standard Deviation 9.8
|
PRIMARY outcome
Timeframe: Baseline and Visit 3 [Month 6]Population: All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.
The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.
Outcome measures
| Measure |
Adalimumab
n=57 Participants
Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change in State Trait Anxiety Index (STAI) Trait Scores From Baseline to After 6 Months of Treatment With Adalimumab
|
-9.0 scores on a scale
Standard Deviation 9.2
|
PRIMARY outcome
Timeframe: Baseline and Visit 3 [Month 6]Population: All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.
HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.
Outcome measures
| Measure |
Adalimumab
n=59 Participants
Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab
Case to Normal
|
1 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab
Case to Suggestive
|
2 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab
Normal to Normal
|
33 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab
Normal to Suggestive
|
5 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab
Normal to Case
|
2 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab
Suggestive to Normal
|
5 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab
Suggestive to Suggestive
|
7 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab
Suggestive to Case
|
0 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab
Case to Case
|
4 participants
|
PRIMARY outcome
Timeframe: Baseline and Visit 3 [Month 6]Population: All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.
HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.
Outcome measures
| Measure |
Adalimumab
n=59 Participants
Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab
Normal to Normal
|
47 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab
Normal to Suggestive
|
8 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab
Normal to Case
|
0 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab
Suggestive to Normal
|
0 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab
Suggestive to Suggestive
|
2 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab
Suggestive to Case
|
0 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab
Case to Normal
|
1 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab
Case to Suggestive
|
1 participants
|
|
Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab
Case to Case
|
0 participants
|
SECONDARY outcome
Timeframe: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]Population: All data were analyzed as observed and missing values were not replaced by any imputation method.
The sIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). A higher score indicates a better HRQoL.
Outcome measures
| Measure |
Adalimumab
n=77 Participants
Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
|
|---|---|
|
Short Inflammatory Bowel Disease Questionnaire (sIBDQ) Scores by Visit
Visit 3 [N=63]
|
5.22 scores on a scale
Standard Deviation 1.06
|
|
Short Inflammatory Bowel Disease Questionnaire (sIBDQ) Scores by Visit
Visit 1 [N=77]
|
4.58 scores on a scale
Standard Deviation 1.21
|
|
Short Inflammatory Bowel Disease Questionnaire (sIBDQ) Scores by Visit
Visit 2 [N=48]
|
5.19 scores on a scale
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]Population: All data were analyzed as observed and missing values were not replaced by any imputation method.
Harvey-Bradshaw Index (HBI) is for use in the assessment and quantification of symptoms and the present level of disease activity of patients with Crohn's disease. It is a validated clinical index for Crohn's disease, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25 with higher scores indicating higher disease activity. The scores were classified as follows: less than 5 is remission, 5 to 7 is mild, 8 to 16 is moderate, and greater than 16 is severe.
Outcome measures
| Measure |
Adalimumab
n=76 Participants
Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
|
|---|---|
|
Harvey-Bradshaw Index (HBI) Scores by Visit
Visit 1: Remission [N=76]
|
22 participants
|
|
Harvey-Bradshaw Index (HBI) Scores by Visit
Visit 1: Mild [N=76]
|
26 participants
|
|
Harvey-Bradshaw Index (HBI) Scores by Visit
Visit 2: Remission [N=50]
|
38 participants
|
|
Harvey-Bradshaw Index (HBI) Scores by Visit
Visit 2: Mild [N=50]
|
6 participants
|
|
Harvey-Bradshaw Index (HBI) Scores by Visit
Visit 2: Moderate [N=50]
|
6 participants
|
|
Harvey-Bradshaw Index (HBI) Scores by Visit
Visit 2: Severe [N=50]
|
0 participants
|
|
Harvey-Bradshaw Index (HBI) Scores by Visit
Visit 3: Remission [N=60]
|
39 participants
|
|
Harvey-Bradshaw Index (HBI) Scores by Visit
Visit 3: Mild [N=60]
|
11 participants
|
|
Harvey-Bradshaw Index (HBI) Scores by Visit
Visit 3: Moderate [N=60]
|
10 participants
|
|
Harvey-Bradshaw Index (HBI) Scores by Visit
Visit 3: Severe [N=60]
|
0 participants
|
|
Harvey-Bradshaw Index (HBI) Scores by Visit
Visit 1: Moderate [N=76]
|
27 participants
|
|
Harvey-Bradshaw Index (HBI) Scores by Visit
Visit 1: Severe [N=76]
|
1 participants
|
SECONDARY outcome
Timeframe: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]Population: All data were analyzed as observed and missing values were not replaced by any imputation method.
The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.
Outcome measures
| Measure |
Adalimumab
n=79 Participants
Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
|
|---|---|
|
State Trait Anxiety Index (STAI) State Scores by Visit
Visit 1 [N=79]
|
40.4 scores on a scale
Standard Deviation 10.7
|
|
State Trait Anxiety Index (STAI) State Scores by Visit
Visit 2 [N=49]
|
38.1 scores on a scale
Standard Deviation 10.2
|
|
State Trait Anxiety Index (STAI) State Scores by Visit
Visit 3 [N=61]
|
38.0 scores on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]Population: All data were analyzed as observed and missing values were not replaced by any imputation method.
The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.
Outcome measures
| Measure |
Adalimumab
n=77 Participants
Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
|
|---|---|
|
State Trait Anxiety Index (STAI) Trait Scores by Visit
Visit 1 [N=77]
|
38.9 scores on a scale
Standard Deviation 10.8
|
|
State Trait Anxiety Index (STAI) Trait Scores by Visit
Visit 2 [N=48]
|
38.1 scores on a scale
Standard Deviation 11.2
|
|
State Trait Anxiety Index (STAI) Trait Scores by Visit
Visit 3 [N=61]
|
37.0 scores on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]Population: All data were analyzed as observed and missing values were not replaced by any imputation method.
HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.
Outcome measures
| Measure |
Adalimumab
n=79 Participants
Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
|
|---|---|
|
Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit
Visit 1: Normal [N=79]
|
52 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit
Visit 1: Suggestive [N=79]
|
16 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit
Visit 1: Case [N=79]
|
11 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit
Visit 2: Normal [N=50]
|
32 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit
Visit 2: Suggestive [N=50]
|
12 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit
Visit 2: Case [N=50]
|
6 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit
Visit 3: Normal [N=61]
|
40 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit
Visit 3: Suggestive [N=61]
|
14 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit
Visit 3: Case [N=61]
|
7 participants
|
SECONDARY outcome
Timeframe: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]Population: All data were analyzed as observed and missing values were not replaced by any imputation method.
HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.
Outcome measures
| Measure |
Adalimumab
n=79 Participants
Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
|
|---|---|
|
Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit
Visit 1: Suggestive [N=79]
|
5 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit
Visit 1: Case [N=79]
|
5 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit
Visit 2: Normal [N=50]
|
41 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit
Visit 3: Case [N=61]
|
1 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit
Visit 1: Normal [N=79]
|
69 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit
Visit 2: Suggestive [N=50]
|
7 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit
Visit 2: Case [N=50]
|
2 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit
Visit 3: Normal [N=61]
|
49 participants
|
|
Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit
Visit 3: Suggestive [N=61]
|
11 participants
|
Adverse Events
Adalimumab
Serious adverse events
| Measure |
Adalimumab
n=83 participants at risk
40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/83 • From the time of informed consent up to 70 days following the intake of the last dose of physician-prescribed treatment
Only Serious Adverse Events were required to collect, therefore other Adverse Events were not collected
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
1.2%
1/83 • From the time of informed consent up to 70 days following the intake of the last dose of physician-prescribed treatment
Only Serious Adverse Events were required to collect, therefore other Adverse Events were not collected
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
1.2%
1/83 • From the time of informed consent up to 70 days following the intake of the last dose of physician-prescribed treatment
Only Serious Adverse Events were required to collect, therefore other Adverse Events were not collected
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
1.2%
1/83 • From the time of informed consent up to 70 days following the intake of the last dose of physician-prescribed treatment
Only Serious Adverse Events were required to collect, therefore other Adverse Events were not collected
|
|
General disorders
Drug ineffective
|
1.2%
1/83 • From the time of informed consent up to 70 days following the intake of the last dose of physician-prescribed treatment
Only Serious Adverse Events were required to collect, therefore other Adverse Events were not collected
|
|
Nervous system disorders
Paraesthesia
|
1.2%
1/83 • From the time of informed consent up to 70 days following the intake of the last dose of physician-prescribed treatment
Only Serious Adverse Events were required to collect, therefore other Adverse Events were not collected
|
|
Gastrointestinal disorders
Anal Abscess
|
2.4%
2/83 • From the time of informed consent up to 70 days following the intake of the last dose of physician-prescribed treatment
Only Serious Adverse Events were required to collect, therefore other Adverse Events were not collected
|
|
Gastrointestinal disorders
Crohn's disease
|
1.2%
1/83 • From the time of informed consent up to 70 days following the intake of the last dose of physician-prescribed treatment
Only Serious Adverse Events were required to collect, therefore other Adverse Events were not collected
|
Other adverse events
Adverse event data not reported
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER