Trial Outcomes & Findings for Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab Therapy (Study P04644AM1) (TERMINATED) (NCT NCT00521924)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

8 participants

Primary outcome timeframe

after 38 weeks

Results posted on

2017-04-12

Participant Flow

Due to poor enrollment rate, this trial was terminated prematurely. Eight patients had been enrolled from June 2007 to April 2008: 4 in each arm.

Participant milestones

Participant milestones
Measure	Infliximab + Basic Treatment 3 mg/kg infliximab plus basic treatment	Basic Treatment (DMARDs) Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs \[DMARDs\])
Overall Study STARTED	4	4
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab Therapy (Study P04644AM1) (TERMINATED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab + Basic Treatment n=4 Participants 3 mg/kg infliximab plus basic treatment	Basic Treatment (DMARDs) n=4 Participants Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs \[DMARDs\])	Total n=8 Participants Total of all reporting groups
Age, Customized	4 participants n=93 Participants	4 participants n=4 Participants	8 participants n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants

PRIMARY outcome

Timeframe: after 38 weeks

Population: This trial terminated early due to poor enrollment. Since none of the randomized patients reached Week 38, no change of DAS28 between baseline and Week 38 could be analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 14, 38, and 62

These were not prespecified key secondary outcomes; therefore, results will not be disclosed.

Outcome measures

Outcome data not reported

Adverse Events

Infliximab + Basic Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Basic Treatment (DMARDs)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

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 Principal Investigator (PI) has the right to publish/publicly present the results of the Study, but may not to publish/publicly present any interim results. PI must provide 45 days written notice to Sponsor prior to submission for publication/presentation to permit Sponsor to review drafts for publication which report any results arising out of the Study. Sponsor shall have the right to review and comment on any Public Presentation.
Publication restrictions are in place

Restriction type: OTHER