Spondylitis, Ankylosing
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 of tuberculosis screening and to reinforce the patient eligibility for a treatment with Remicade according to the Summary of Product Characteristics (SmPc).
Detailed description
This study population was chosen from a non-probability sample.
Interventions
BIOLOGICALInfliximab
Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
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 ankylosing spondylitis.
Exclusion criteria
* As per Summary of Product Characteristics (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 | 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 screening 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 Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the Time of Enrollment and at the First Infusion | Baseline and time of first infusion | The BASDAI score was calculated based on the responses to questions 1-6, with each component rated on a scale of 0 (best) to 10 (worst) based on the severity of various characteristics. A decrease in BASDAI over time indicated improvement in disease activity. The score corresponded to the sum of the point values from questions 1-4 and the mean of the point values from questions 5 and 6, subsequently divided by five. BASDAI was calculated at the time of enrollment (baseline) and at the time of first infusion. |
Participant flow
Recruitment details
Participants were those with Ankylosing spondylitis (AS) starting treatment with Remicade at 26 sites in Germany from Jul 2003 through Dec 2010
Participants by arm
| Arm | Count |
|---|---|
| Infliximab Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC) | 320 |
| Total | 320 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 19 |
| Overall Study | Lack of Efficacy | 18 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Participant Moved | 2 |
| Overall Study | Pregnancy | 2 |
| Overall Study | Reason for Non-completion Not reported | 6 |
| Overall Study | Withdrawal by Subject | 16 |
Baseline characteristics
| Characteristic | Infliximab |
|---|---|
| Age, Continuous | 40.99 years STANDARD_DEVIATION 12.02 |
| Region of Enrollment Germany | 320 participants |
| Sex: Female, Male Female | 110 Participants |
| Sex: Female, Male Male | 210 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 320 |
| serious Total, serious adverse events | 2 / 320 |
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 screening 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
Population: Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.
| 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 | 290 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 | 29 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 | 1 Participants |
Primary
Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting
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
Population: Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.
| 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 | Yes | 9 Participants |
| Infliximab | Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting | No | 154 Participants |
| Infliximab | Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting | Missing | 157 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
Population: Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.
| 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 | 310 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 | 9 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 | 1 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
Population: Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.
| 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 | 8 Participants |
| Infliximab | Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment | No | 311 Participants |
| Infliximab | Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment | Missing | 1 Participants |
Secondary
Assessment of Disease Activity by Means of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the Time of Enrollment and at the First Infusion
The BASDAI score was calculated based on the responses to questions 1-6, with each component rated on a scale of 0 (best) to 10 (worst) based on the severity of various characteristics. A decrease in BASDAI over time indicated improvement in disease activity. The score corresponded to the sum of the point values from questions 1-4 and the mean of the point values from questions 5 and 6, subsequently divided by five. BASDAI 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 AS patients whose data was entered into the database and finalized by signature of the physician.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infliximab | Assessment of Disease Activity by Means of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the Time of Enrollment and at the First Infusion | BASDAI at Time of Enrollment (n=268) | 5.15 Units on a scale | Standard Deviation 2.14 |
| Infliximab | Assessment of Disease Activity by Means of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the Time of Enrollment and at the First Infusion | BASDAI at First Infusion (n=82) | 5.19 Units on a scale | Standard Deviation 2.35 |