Trial Outcomes & Findings for Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED) (NCT NCT00724243)

Results Overview

The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Participants can be scored on a range of 0 to 10, with lower scores indicating less disease activity.

Recruitment status

COMPLETED

Target enrollment

33 participants

Primary outcome timeframe

Baseline, Week 14, and Week 54

Results posted on

2015-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Infliximab Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
Overall Study STARTED	33
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Infliximab Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
Overall Study Lack of Efficacy	10
Overall Study Adverse Event	5

Baseline Characteristics

Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab n=33 Participants Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
Age, Continuous	43.38 years STANDARD_DEVIATION 10.74 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Slovakia	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 14, and Week 54

Population: Thirty-three participants had a DAS 28 score at the beginning of treatment. Twenty-eight participants had a DAS 28 score at Week 14. Twenty-two participants had a DAS 28 score at Week 54.

The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Participants can be scored on a range of 0 to 10, with lower scores indicating less disease activity.

Outcome measures

Outcome measures
Measure	Infliximab n=33 Participants Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment Baseline	7.11 Units on a Scale Standard Deviation 0.65
Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment Week 14	2.94 Units on a Scale Standard Deviation 1.22
Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment Week 54	3.27 Units on a Scale Standard Deviation 1.59

PRIMARY outcome

Timeframe: Week 14 and Week 54

Response to treatment was assessed by EULAR response criteria. According to these criteria, participants were characterized as good, moderate, or non-responders based on both DAS level attained and change in DAS. Good response was defined as \>1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of \>0.6 but ≤1.2 and DAS attained during follow-up of \>3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.

Outcome measures

Outcome measures
Measure	Infliximab n=33 Participants Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria Week 14	27 Participants
Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria Week 54	19 Participants

Adverse Events

Infliximab

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Infliximab n=33 participants at risk Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
General disorders Allergic reactions to infusion	12.1% 4/33 • Number of events 4

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contractor agrees to acknowledge his contractual relationship with Sponsor in his lecturing or publication activities in relation to subject matter and/or in relation to any other matter concerning Sponsor. However, unless Sponsor's prior consent was given, Contractor shall not specify in more detail the content or subject matter of his contract. Contractor shall not publish or provide to 3rd parties for publication purposes any results of his activities without Sponsor's prior written consent.
Publication restrictions are in place

Restriction type: OTHER