Trial Outcomes & Findings for Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED) (NCT NCT00818168)

NCT ID: NCT00818168

Last Updated: 2015-09-03

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: 320 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2015-09-03

Participant Flow

Participants were those with Ankylosing spondylitis (AS) starting treatment with Remicade at 26 sites in Germany from Jul 2003 through Dec 2010

Participant milestones

Measure	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)
Overall Study STARTED	320
Overall Study COMPLETED	250
Overall Study NOT COMPLETED	70

Reasons for withdrawal

Measure	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)
Overall Study Lack of Efficacy	18
Overall Study Pregnancy	2
Overall Study Withdrawal by Subject	16
Overall Study Lost to Follow-up	7
Overall Study Adverse Event	19
Overall Study Reason for Non-completion Not reported	6
Overall Study Participant Moved	2

Baseline Characteristics

Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED)

Baseline characteristics by cohort

Measure	Infliximab n=320 Participants 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)
Age, Continuous	40.99 years STANDARD_DEVIATION 12.02 • n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants
Sex: Female, Male Male	210 Participants n=5 Participants
Region of Enrollment Germany	320 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.

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

Measure	Infliximab n=320 Participants 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)
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
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
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: Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.

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

Measure	Infliximab n=320 Participants 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)
Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment Yes	8 Participants
Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment No	311 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: Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.

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

Measure	Infliximab n=320 Participants 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)
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
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
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 outcome

Timeframe: Baseline

Population: Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.

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

Outcome measures

Measure	Infliximab n=320 Participants 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)
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
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
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

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Infliximab n=320 Participants 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)
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
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

Adverse Events

Infliximab

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Infliximab n=320 participants at risk 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)
Immune system disorders anaphylactic shock	0.31% 1/320 • Number of events 1
Musculoskeletal and connective tissue disorders lupus-like disease	0.31% 1/320 • 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: ClinicalTrialsDisclosure@merck.com

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