Trial Outcomes & Findings for Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery (NCT NCT00688636)

Last Updated: 2016-09-26

Results Overview

Endoscopic recurrence was defined as i2,i3,i4. We used the Rutgeerts' Endoscopic Scoring System. Scores as follows i0, no lesions; i1, 5 or fewer aphthous lesions; i2, more than 5 aphthous lesions with normal mucosa between the lesions or skip areas of larger lesions or lesions confined to the ileocolonic anastomosis; i3, diffuse, aphthous ileitis with diffusely inflamed mucosa; and i4, diffuse inflammation with large ulcers, nodules, and/or narrowing. Endoscopic recurrence was defined as i2,i3,i4 and endoscopic remission was defined as i0 or i1.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

one year

Results posted on

2016-09-26

Participant Flow

Between 2005 and 2007 there were 24 adult patients with ileal or ileocolonic Crohn's disease undergoing resection who participated in the study.

Participant milestones

Participant milestones
Measure	Infliximab infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks	Placebo placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
Overall Study STARTED	11	13
Overall Study COMPLETED	9	12
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Infliximab infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks	Placebo placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
Overall Study Adverse Event	2	1

Baseline Characteristics

Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab n=11 Participants infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks	Placebo n=13 Participants placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks	Total n=24 Participants Total of all reporting groups
Age, Continuous	43.0 years n=5 Participants	32.0 years n=7 Participants	38.0 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Population: The proportion of patients with endoscopic recurrence (\> or = i2) at 1 year after surgery

Outcome measures

Outcome measures
Measure	Infliximab n=11 Participants infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6	Placebo n=13 Participants placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year	1 participants	11 participants

SECONDARY outcome

Timeframe: One year

Population: CDAI score \> 200

The Crohn's Disease Activity Index (CDAI) is calculated by a measurement of symptoms, signs, and lab tests over a time period of the previous 7 days. The CDAI includes: Number of very soft stools; sum of abdominal pain ratings: (0=none, 1= mild, 2=moderate, 3=severe); general well being (0=well, 1=slightly below par, 2=poor, 3=very poor, 4=terrible); Symptoms or findings presumed related to Crohn's disease (present): arthritis or arthralgia, iritis or uveitis, erythema nodosum, pyoderma gangrenosum, aphthous stomatitis, anal fissure, fistula or perirectal abscess, other bowel related fistula, febrile episode over 100 degrees during past week, taking lomotil or opiates for diarrhea, abnormal mass (0=none; 0.4=questionable; 1=present) hematocrit \[(typical-current) X 6\] Normal average male = 47, female =42, body weight

Outcome measures

Outcome measures
Measure	Infliximab n=11 Participants infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6	Placebo n=13 Participants placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
Clinical Recurrence at One Year: Defined by Crohn's Disease Activity Index (CDAI) > 200	0 participants	5 participants

SECONDARY outcome

Timeframe: One year

Population: Histologic activity score

Histologic recurrence based on a histologic activity score and the presence of polymononuclear cells. The maximum score is 14 per biopsy site.

Outcome measures

Outcome measures
Measure	Infliximab n=11 Participants infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6	Placebo n=13 Participants placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
Histological Recurrence of Crohn's Disease as Determined From Biopsies of Neo-terminal Ileum Above the Ileocolonic Anastomosis	3 participants	11 participants

SECONDARY outcome

Timeframe: one year

The CRP was obtained at each study visit as a surrogate marker of inflammation. The CRP was recorded as milligram per deciliter (mg/dl). A normal CRP was 0-0.8 mg/dl; levels exceeding 0.8 mg/dl indicated inflammation.

Outcome measures

Outcome measures
Measure	Infliximab n=11 Participants infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6	Placebo n=13 Participants placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
C-reactive Protein Concentration as a Surrogate Marker of Inflammation	0.5 mg/dL Interval 0.05 to 0.8	0.6 mg/dL Interval 0.2 to 1.5

SECONDARY outcome

Timeframe: one year

erythrocyte sedimentation rate value - blood test

Outcome measures

Outcome measures
Measure	Infliximab n=11 Participants infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6	Placebo n=13 Participants placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
Mean Erythrocyte Sedimentation Rate	30 mm/h Interval 10.0 to 40.0	19 mm/h Interval 9.0 to 34.0

Adverse Events

Infliximab

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infliximab n=11 participants at risk infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks	Placebo n=13 participants at risk placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Number of events 1 • 12 months	0.00% 0/13 • 12 months

Other adverse events

Other adverse events
Measure	Infliximab n=11 participants at risk infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks	Placebo n=13 participants at risk placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
Infections and infestations Bronchitis	9.1% 1/11 • Number of events 1 • 12 months	0.00% 0/13 • 12 months
Infections and infestations Nasopharyngitis	9.1% 1/11 • Number of events 1 • 12 months	15.4% 2/13 • Number of events 2 • 12 months
Respiratory, thoracic and mediastinal disorders Lung nodules	0.00% 0/11 • 12 months	7.7% 1/13 • Number of events 1 • 12 months
Gastrointestinal disorders partial small-bowel obstruction	0.00% 0/11 • 12 months	7.7% 1/13 • Number of events 1 • 12 months
Infections and infestations Gastroenteritis	0.00% 0/11 • 12 months	7.7% 1/13 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders arthralgia	0.00% 0/11 • 12 months	15.4% 2/13 • Number of events 2 • 12 months
Infections and infestations pyleonephritis	9.1% 1/11 • Number of events 1 • 12 months	0.00% 0/13 • 12 months
General disorders fever	0.00% 0/11 • 12 months	7.7% 1/13 • Number of events 1 • 12 months
Immune system disorders lupus-like reaction	9.1% 1/11 • Number of events 1 • 12 months	0.00% 0/13 • 12 months
Infections and infestations abcess	9.1% 1/11 • Number of events 1 • 12 months	7.7% 1/13 • Number of events 1 • 12 months
Gastrointestinal disorders crohn's disease exacerbation	0.00% 0/11 • 12 months	7.7% 1/13 • Number of events 1 • 12 months
Immune system disorders Infusion reaction	18.2% 2/11 • Number of events 2 • 12 months	7.7% 1/13 • Number of events 1 • 12 months

Additional Information

Research Coordinator

Univerisity of Pittsburgh

Phone: 412-648-9173

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place