Trial Outcomes & Findings for Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy (NCT NCT00886795)

Last Updated: 2016-01-25

Results Overview

Participants were monitored for adverse events (AEs) at each visit. Cumulative AEs were tracked including specific AE, severity, and relationship on source documentation. Special attention was given to infusion-related events and hypersensitivity reactions. Assessment of Complete Blood Count (CBC) and Metabolic profile were also tracked.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

baseline, 3 month and 6 months

Results posted on

2016-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	Abatacept 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks. abatacept (Orencia ®): 4 infusions of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks. The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of \>60 kg, 60-100kg, or 100 kg respectively.
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Abatacept 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks. abatacept (Orencia ®): 4 infusions of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks. The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of \>60 kg, 60-100kg, or 100 kg respectively.
Overall Study Lack of Efficacy	1

Baseline Characteristics

Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abatacept n=4 Participants 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks. abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of \>60 kg, 60-100kg, or 100 kg respectively.
Age, Continuous	43 years STANDARD_DEVIATION 7.29 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 3 month and 6 months

Population: Participants who received all four doses.

Outcome measures

Outcome measures
Measure	Abatacept n=4 Participants 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks. abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of \>60 kg, 60-100kg, or 100 kg respectively.
Number of Participants With Adverse Events	3 participants

SECONDARY outcome

Timeframe: at each visit and at 3 months

Evaluations will occur at each visit after the first infusion. At 3 months, response will be recorded and patients with improvement will be eligible to move into the steroid and/or antihistamine tapering portion of the study. Improvement was determined by a reduction in the number of hives.

Outcome measures

Outcome measures
Measure	Abatacept n=4 Participants 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks. abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of \>60 kg, 60-100kg, or 100 kg respectively.
Number of Participants With Clinically Detectable Improvement	4 participants

Adverse Events

Abatacept

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Abatacept n=4 participants at risk 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks. abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of \>60 kg, 60-100kg, or 100 kg respectively.
Nervous system disorders Headache	50.0% 2/4 • Number of events 3 • 3 years Adverse events were collected by patient report at each study visit in response to open ended questioning.
Respiratory, thoracic and mediastinal disorders Common Cold	50.0% 2/4 • Number of events 2 • 3 years Adverse events were collected by patient report at each study visit in response to open ended questioning.
Respiratory, thoracic and mediastinal disorders Influenza	50.0% 2/4 • Number of events 2 • 3 years Adverse events were collected by patient report at each study visit in response to open ended questioning.
Musculoskeletal and connective tissue disorders Diastasis	25.0% 1/4 • Number of events 1 • 3 years Adverse events were collected by patient report at each study visit in response to open ended questioning.
Infections and infestations Ear Infection	25.0% 1/4 • Number of events 1 • 3 years Adverse events were collected by patient report at each study visit in response to open ended questioning.
Nervous system disorders Hypoesthesia	25.0% 1/4 • Number of events 1 • 3 years Adverse events were collected by patient report at each study visit in response to open ended questioning.
Musculoskeletal and connective tissue disorders Right Shoulder Pain	25.0% 1/4 • Number of events 1 • 3 years Adverse events were collected by patient report at each study visit in response to open ended questioning.
General disorders Rhinorrhea	25.0% 1/4 • Number of events 1 • 3 years Adverse events were collected by patient report at each study visit in response to open ended questioning.
Respiratory, thoracic and mediastinal disorders Sinus Infection	25.0% 1/4 • Number of events 1 • 3 years Adverse events were collected by patient report at each study visit in response to open ended questioning.
Skin and subcutaneous tissue disorders Tinea Pedis	25.0% 1/4 • Number of events 1 • 3 years Adverse events were collected by patient report at each study visit in response to open ended questioning.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	25.0% 1/4 • Number of events 1 • 3 years Adverse events were collected by patient report at each study visit in response to open ended questioning.

Additional Information

Clifton O. Bingham III, M.D.

Johns Hopkins University

Phone: 410-550-0578

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60