Trial Outcomes & Findings for Tocilizumab for the Treatment of Behcet's Syndrome (NCT NCT01693653)

NCT ID: NCT01693653

Last Updated: 2019-02-15

Results Overview

The study was terminated. No data were collected for this Outcome Measure.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

9 months

Results posted on

2019-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Tocilizumab tocilizumab infusion every 4 weeks over 3 months Tocilizumab: Intravenous infusions every 4 weeks for 3 doses.	Placebo placebo infusion 0.9% sodium chloride every 4 weeks over 3 months Tocilizumab: Intravenous infusions every 4 weeks for 3 doses.
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tocilizumab for the Treatment of Behcet's Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tocilizumab n=1 Participants tocilizumab infusion every 4 weeks over 3 months Tocilizumab: Intravenous infusions every 4 weeks for 3 doses.	Placebo placebo infusion 0.9% sodium chloride every 4 weeks over 3 months Tocilizumab: Intravenous infusions every 4 weeks for 3 doses.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex/Gender, Customized	1 participants n=5 Participants	—	1 participants n=5 Participants
Race/Ethnicity, Customized	1 particpants n=5 Participants	—	1 particpants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: The study was terminated. No data were collected for this Outcome Measure.

The study was terminated. No data were collected for this Outcome Measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Terminated due to low enrollments. Data for 1 subject not analyzed.

The study was terminated. No data were collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Terminated due to low enrollments. Data for 1 subject not analyzed.

The study was terminated. No data were collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Terminated due to low enrollments. Data for 1 subject not analyzed.

The study was terminated. No data were collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Terminated due to low enrollments. Data for 1 subject not analyzed.

The study was terminated. No data were collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Terminated due to low enrollments. Data for 1 subject not analyzed.

The study was terminated. No data were collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Terminated due to low enrollments. Data for 1 subject not analyzed.

The study was terminated. No data were collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Terminated due to low enrollments. Data for 1 subject not analyzed.

The study was terminated. No data were collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Terminated due to low enrollments. Data for 1 subject not analyzed.

The study was terminated. No data were collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 moths

Population: Terminated due to low enrollments. Data for 1 subject not analyzed.

The study was terminated. No data were collected for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

Tocilizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Yusuf Yazici

NYU Langone Medical Center, Center for Musculoskeletal Care

Phone: 646-501-7400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place