Trial Outcomes & Findings for Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED) (NCT NCT00818272)

Results Overview

In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (tuberculin sensitivity skin test by intradermal injection) as the first screening test was presented in three categories: * Yes * No * Missing (represents no entry, but may mean another test was performed as first screening test and documented)

Recruitment status

COMPLETED

Target enrollment

148 participants

Primary outcome timeframe

Baseline

Results posted on

2015-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	Infliximab Participants with confirmed diagnosis of severe active Crohn's disease (CD) and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
Overall Study STARTED	148
Overall Study COMPLETED	74
Overall Study NOT COMPLETED	74

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab n=148 Participants Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
Age, Continuous	36.01 years STANDARD_DEVIATION 11.13 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (tuberculin sensitivity skin test by intradermal injection) as the first screening test was presented in three categories: * Yes * No * Missing (represents no entry, but may mean another test was performed as first screening test and documented)

Outcome measures

Outcome measures
Measure	Infliximab n=148 Participants Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment Yes	92 Participants
Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment No	53 Participants
Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment Missing	3 Participants

PRIMARY outcome

Timeframe: Baseline

In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (multiple puncture tuberculin skin test) as the first screening test was presented in three categories: * Yes * No * Missing (represents no entry, but may mean another test was performed as first screening test and documented)

Outcome measures

Outcome measures
Measure	Infliximab n=148 Participants Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment Yes	40 Participants
Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment No	105 Participants
Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment Missing	3 Participants

PRIMARY outcome

Timeframe: Baseline

In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the in-vitro TB test (cellular blood test, i.e. gamma interferon release assays) as the first screening test was presented in three categories: * Yes * No * Missing (represents no entry, but may mean another test was performed as first screening test and documented)

Outcome measures

Outcome measures
Measure	Infliximab n=148 Participants Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment Yes	0 Participants
Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment No	90 Participants
Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment Missing	58 Participants

PRIMARY outcome

Timeframe: Baseline

In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised a TB screeing test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories: * Yes * No * Missing

Outcome measures

Outcome measures
Measure	Infliximab n=148 Participants Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment Yes	131 Participants
Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment No	14 Participants
Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment Missing	3 Participants

SECONDARY outcome

Timeframe: Baseline and time of first Infusion

Population: Data was analyzed for all CD participants whose data had been entered in the database and finalized by signature of the physician. 90 out of 148 participants available at enrollment completed the CDAI and 42 out of the 128 available participants at first infusion after screening (beginning of 2 year observation period) completed the CDAI.

The CDAI score is used to quantify the symptoms of participants with CD. The CDAI incorporates 8 items added together that are indicators of disease severity. Scores range from 0 to 600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. A decrease in CDAI over time indicates improvement in disease activity. CDAI was calculated at the time of enrollment (baseline) and at the time of first infusion.

Outcome measures

Outcome measures
Measure	Infliximab n=148 Participants Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
Assessment of Disease Activity by Means of the Crohn's Disease Activity Index (CDAI) at the Time of Enrollment and at the First Infusion CDAI at Time of Enrollment (N=90)	302.67 Score on a scale Standard Deviation 126.22
Assessment of Disease Activity by Means of the Crohn's Disease Activity Index (CDAI) at the Time of Enrollment and at the First Infusion CDAI at First Infusion (N=42)	323.21 Score on a scale Standard Deviation 131.45

Adverse Events

Infliximab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Trial results belong to the SPONSOR only, all investigators are not allowed to publish trial results without permission of the SPONSOR.
Publication restrictions are in place

Restriction type: OTHER