Crohn's Disease
Conditions
Keywords
Crohn's Disease
Brief summary
The purpose of this study is to evaluate the long term efficacy, safety, and tolerability of repeated administration of adalimumab in participants with Crohn's disease.
Interventions
DRUGAdalimumab
Adalimumab pre-filled syringe, administered by subcutaneous injection
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\- Subject successfully enrolled in and completed Study M14-115 (NCT02185014), including the Week 12 ileocolonoscopy.
Exclusion criteria
* If the Week 12 (Study M14-115; NCT02185014) colonoscopy shows evidence of dysplasia or malignancy. * Subject is not in compliance with prior and concomitant medication requirements throughout M14-115 (NCT02185014). * Subject who developed active Tuberculosis (TB) during M14-115 (NCT02185014), or subject who is non compliant with prophylaxis for latent tuberculosis (TB) initiated per M14-115 (NCT02185014) procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Endoscopic Improvement at Week 40 in Participants With Endoscopic Improvement at Week 0 | Week 40 | Endoscopic improvement defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of ≤4 and at least a 2-point reduction compared with Study M14-115 (NCT02185014) Baseline and no subscore greater than 1 in any individual endoscopic variable. 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. Nonresponder imputation (NRI) was used for missing data. |
Participant flow
Pre-assignment details
Participants who completed Study M14-115 (NCT02185014) were eligible to enroll in this study.
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks. | 252 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 18 |
| Overall Study | Lack of Efficacy | 14 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Other | 4 |
| Overall Study | Requires Alternative/Prohibited Therapy | 5 |
| Overall Study | Subject Noncompliance | 1 |
| Overall Study | Withdrew Consent | 8 |
Baseline characteristics
| Characteristic | Adalimumab |
|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 12.71 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 245 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 229 Participants |
| Sex: Female, Male Female | 139 Participants |
| Sex: Female, Male Male | 113 Participants |
| Simplified endoscopic score for crohn's disease (SES-CD) | 14.2 units on a scale STANDARD_DEVIATION 6.74 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 252 |
| other Total, other adverse events | 63 / 252 |
| serious Total, serious adverse events | 27 / 252 |
Outcome results
Primary
Percentage of Participants With Endoscopic Improvement at Week 40 in Participants With Endoscopic Improvement at Week 0
Endoscopic improvement defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of ≤4 and at least a 2-point reduction compared with Study M14-115 (NCT02185014) Baseline and no subscore greater than 1 in any individual endoscopic variable. 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. Nonresponder imputation (NRI) was used for missing data.
Time frame: Week 40
Population: All enrolled participants who had endoscopic improvement at Week 0 in Study M14-347 (end of lead-in Study M14-115 \[NCT02185014\])
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants With Endoscopic Improvement at Week 40 in Participants With Endoscopic Improvement at Week 0 | 31.6 percentage of participants |