Trial Outcomes & Findings for Remicade Safety Line (Study P03236)(COMPLETED) (NCT NCT00748826)

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) per clinical testing as the first screening test was presented in three categories: * Yes * No * Missing

Recruitment status

COMPLETED

Target enrollment

576 participants

Primary outcome timeframe

Baseline

Results posted on

2015-09-03

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	508
Overall Study COMPLETED	207
Overall Study NOT COMPLETED	301

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Remicade Safety Line (Study P03236)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab n=508 Participants 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
Age, Continuous	52.80 years STANDARD_DEVIATION 13.56 • n=5 Participants
Sex: Female, Male Female	357 Participants n=5 Participants
Sex: Female, Male Male	151 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Infliximab n=508 Participants 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
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
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
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 outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Infliximab n=508 Participants 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
Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment Yes	23 participants
Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment No	484 participants
Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment Missing	1 participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Infliximab n=508 Participants 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
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
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
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 outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Infliximab n=508 Participants 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
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
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
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

Adverse Events

Infliximab

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infliximab n=508 participants at risk 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
Cardiac disorders Myocardial Infarction	0.20% 1/508 • Number of events 1

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