Trial Outcomes & Findings for Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115 (NCT NCT02185014)

Last Updated: 2018-11-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

252 participants

Primary outcome timeframe

Week 40

Results posted on

2018-11-14

Participant Flow

Participants who completed Study M14-115 (NCT02185014) were eligible to enroll in this study.

Participant milestones

Participant milestones
Measure	Adalimumab Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.
Overall Study STARTED	252
Overall Study COMPLETED	198
Overall Study NOT COMPLETED	54

Reasons for withdrawal

Reasons for withdrawal
Measure	Adalimumab Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.
Overall Study Adverse Event	18
Overall Study Withdrew Consent	8
Overall Study Lost to Follow-up	4
Overall Study Lack of Efficacy	14
Overall Study Requires Alternative/Prohibited Therapy	5
Overall Study Subject Noncompliance	1
Overall Study Other	4

Baseline Characteristics

Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adalimumab n=252 Participants Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.
Age, Continuous	37.5 years STANDARD_DEVIATION 12.71 • n=5 Participants
Sex: Female, Male Female	139 Participants n=5 Participants
Sex: Female, Male Male	113 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	245 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	229 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Simplified endoscopic score for crohn's disease (SES-CD)	14.2 units on a scale STANDARD_DEVIATION 6.74 • n=5 Participants

PRIMARY outcome

Timeframe: Week 40

Population: All enrolled participants who had endoscopic improvement at Week 0 in Study M14-347 (end of lead-in Study M14-115 \[NCT02185014\])

Outcome measures

Outcome measures
Measure	Adalimumab n=76 Participants Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.
Percentage of Participants With Endoscopic Improvement at Week 40 in Participants With Endoscopic Improvement at Week 0	31.6 percentage of participants Interval 21.1 to 42.0

Adverse Events

Adalimumab

Serious events: 27 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adalimumab n=252 participants at risk Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.40% 1/252 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).
Gastrointestinal disorders CROHN'S DISEASE	5.6% 14/252 • Number of events 16 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).
Gastrointestinal disorders ILEAL STENOSIS	0.40% 1/252 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).
Gastrointestinal disorders INTESTINAL OBSTRUCTION	1.2% 3/252 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	1.6% 4/252 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).
General disorders NON-CARDIAC CHEST PAIN	0.40% 1/252 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).
Infections and infestations ANAL ABSCESS	1.2% 3/252 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.40% 1/252 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.40% 1/252 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).
Nervous system disorders HEADACHE	0.40% 1/252 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).
Renal and urinary disorders NEPHROLITHIASIS	0.40% 1/252 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).

Other adverse events

Other adverse events
Measure	Adalimumab n=252 participants at risk Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.
Gastrointestinal disorders CROHN'S DISEASE	11.9% 30/252 • Number of events 31 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).
Gastrointestinal disorders NAUSEA	6.0% 15/252 • Number of events 21 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	5.2% 13/252 • Number of events 13 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).
Musculoskeletal and connective tissue disorders ARTHRALGIA	7.1% 18/252 • Number of events 20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

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