Trial Outcomes & Findings for ACTHAR for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate (NCT NCT01984268)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

36 weeks

Results posted on

2021-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	Entire Study The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB.
Overall Study STARTED	15
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Entire Study The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB.
Overall Study Study Terminated	15

Baseline Characteristics

ACTHAR for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study n=15 Participants The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB.
Age, Customized >18	15 Participants n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	15 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	15 participants n=93 Participants

PRIMARY outcome

Timeframe: 36 weeks

Population: The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 weeks

Population: The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

Population: The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

Population: The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

Population: The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

Population: The study was placed on voluntary hold prior to completion by the PI. The voluntary hold stayed in place until the study's IRB approval expired. The study was subsequently closed by the IRB. The PI no longer has access to any data, and the PI has left the institution. No reportable study outcome data is available as determined by the IRB.

Outcome measures

Outcome data not reported

Adverse Events

Entire Study

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

Director, Office of Research Operations

Dartmouth-Hitchcock Medical Center

Phone: (603) 650-6340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place