Arthritis, Rheumatoid
Conditions
Brief summary
The goal of this study is to implement instruments that would increase the treating physician's awareness of the necessary tuberculosis screening when starting a new patient on infliximab (Remicade) therapy who has not reacted sufficiently to disease-modifying preparations, including methotrexate.
Detailed description
This study used a non-probability sampling method.
Interventions
BIOLOGICALInfliximab
Patients with active rheumatoid arthritis (RA) confirmed with American College of Rheumatology (ACR) criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, 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
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with active rheumatoid arthritis confirmed with adequate clinical response(ACR) criteria who did not react sufficiently to disease-modifying preparations, including methotrexate, and who are receiving new treatment with infliximab.
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) per clinical testing as the first screening test was presented in three categories: * Yes * No * Missing |
| 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) per clinical testing as the first screening test was presented in three categories: * Yes * No * Missing |
| 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) per clinical testing as the first screening test was presented in three categories: * Yes * No * Missing |
| 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 of 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 |
Participant flow
Pre-assignment details
508 rheumatoid arthritis participants initially enrolled on study. An additional 68 participants with psoriatic arthritis (PsA) were enrolled but were not included in the analyses.
Participants by arm
| Arm | Count |
|---|---|
| Infliximab Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, 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 | 508 |
| Total | 508 |
Baseline characteristics
| Characteristic | Infliximab |
|---|---|
| Age, Continuous | 52.80 years STANDARD_DEVIATION 13.56 |
| Sex: Female, Male Female | 357 Participants |
| Sex: Female, Male Male | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 508 |
| serious Total, serious adverse events | 1 / 508 |
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 of 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: Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.
| 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 | 459 participant |
| Infliximab | Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment | No | 48 participant |
| 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 participant |
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) per clinical testing as the first screening test was presented in three categories: * Yes * No * Missing
Time frame: Baseline
Population: Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.
| 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 | 6 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 | 216 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 | 286 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) per clinical testing as the first screening test was presented in three categories: * Yes * No * Missing
Time frame: Baseline
Population: Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.
| 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 | 481 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 | 26 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) per clinical testing as the first screening test was presented in three categories: * Yes * No * Missing
Time frame: Baseline
Population: Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.
| 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 | 23 participants |
| Infliximab | Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment | No | 484 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 |