Crohn's Disease
Conditions
Brief summary
This observational study is in line with the German educational plan with the aim to implement a tool to increase and monitor the awareness for tuberculosis screening and to reinforce the patient eligibility for a treatment with Remicade according to the Summary of Product Characteristics (SmPc).
Interventions
BIOLOGICALRemicade (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 of infliximab therapy 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).
Sponsors
Centocor, Inc.
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with Crohn's disease.
Exclusion criteria
* As per SmPC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment | 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) |
| Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment | 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) |
| Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment | 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) |
| Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Disease Activity by Means of the Crohn's Disease Activity Index (CDAI) at the Time of Enrollment and at the First Infusion | Baseline and time of first Infusion | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Infliximab 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). | 148 |
| Total | 148 |
Baseline characteristics
| Characteristic | Infliximab |
|---|---|
| Age, Continuous | 36.01 years STANDARD_DEVIATION 11.13 |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 148 |
| serious Total, serious adverse events | 0 / 148 |
Outcome results
Primary
Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment
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
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab | 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 |
| Infliximab | 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 |
| Infliximab | 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 |
Primary
Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment
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)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab | 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 |
| Infliximab | 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 |
| Infliximab | 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
Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment
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)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab | 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 |
| Infliximab | 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 |
| Infliximab | 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
Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment
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)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab | Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment | Yes | 40 Participants |
| Infliximab | Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment | No | 105 Participants |
| Infliximab | Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment | Missing | 3 Participants |
Secondary
Assessment of Disease Activity by Means of the Crohn's Disease Activity Index (CDAI) at the Time of Enrollment and at the First Infusion
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infliximab | 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 |
| Infliximab | 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 |