Trial Outcomes & Findings for Enthesitis With Ultra Sonography Doppler in Spondyloarthropathies Treated With Infliximab (Study P04440) (NCT NCT00686894)

Last Updated: 2017-03-13

Results Overview

Two measures were to be used for each enthesis evaluation. 1.) Vascularization: yes/no. 2.) Area of hyper-vascularization: mm\^2 (continuous) using proprietary software. This study was terminated early due to slow recruitment. As a result, efficacy analyses were not performed.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

7 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Infliximab 5 mg/kg Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
Overall Study STARTED	7
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Infliximab 5 mg/kg Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
Overall Study Relapse	2
Overall Study Protocol Violation	4

Baseline Characteristics

Enthesitis With Ultra Sonography Doppler in Spondyloarthropathies Treated With Infliximab (Study P04440)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab 5 mg/kg n=7 Participants Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Infliximab 5 mg/kg n=7 Participants Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
The Number of Enthesitis Between Week 4 and Week 12 Evaluated Using Power Doppler Ultrasonography (PDUS) and Proprietary Software.	0 Number of Enthesitis

Adverse Events

Infliximab 5 mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Infliximab 5 mg/kg n=7 participants at risk Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
Ear and labyrinth disorders Vertigo	14.3% 1/7 • Number of events 1
Gastrointestinal disorders Constipation	14.3% 1/7 • Number of events 1
Gastrointestinal disorders Nausea	14.3% 1/7 • Number of events 1
Infections and infestations Oral Herpes	14.3% 1/7 • Number of events 1
Skin and subcutaneous tissue disorders Pruritis	14.3% 1/7 • Number of events 1
Skin and subcutaneous tissue disorders Pruritis Generalised	14.3% 1/7 • Number of events 1
Skin and subcutaneous tissue disorders Rash	14.3% 1/7 • Number of events 2
Skin and subcutaneous tissue disorders Skin Plaque	14.3% 1/7 • Number of events 1

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI agrees not to publish or publicly present any interim results of the study without prior written consent of the sponsor. The PI further agrees to provide 45 days written notice to the sponsor prior to submission for publication or presentation to permit the sponsor to review copies of abstracts or manuscripts for publication which report any results of the study. The sponsor shall have the right to review and comment on any presentation.
Publication restrictions are in place

Restriction type: OTHER