Trial Outcomes & Findings for Abatacept in Treating Adults With Mild Relapsing Wegener's Granulomatosis (NCT NCT00468208)

Last Updated: 2016-01-18

Results Overview

This study examined the safety profile of this agent when used in Wegener's granulomatosis. Information was gathered on all adverse events with specific events being identified in the protocol for analysis that included the following: * Infection * Infusion reactions * Cytopenias * Transaminase elevation * Skin reactions * GI side effects * Malignancy All adverse events were reportable for this study.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Measured continuously from the screening visit through to the 6 month post-treatment study visit, up to 3 years and 4 months.

Results posted on

2016-01-18

Participant Flow

Recruitment began in February 2008 and the final subject was enrolled in June 2010. Subjects were recruited through the clinical practices of each site investigator.

At a screening visit, participants underwent procedures to establish inclusion/exclusion criteria and then signed the informed consent form.

Participant milestones

Participant milestones
Measure	Open-label Abatacept Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination. Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study: * 500 mg of abatacept for body weight less than 60 kg * 750 mg of abatacept for body weight between 60 and 100 kg * 1000 mg of abatacept for body weight greater than 100 kg Abatacept was administered in a 30-minute intravenous infusion.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Abatacept in Treating Adults With Mild Relapsing Wegener's Granulomatosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-label Abatacept n=20 Participants Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination. Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study: * 500 mg of abatacept for body weight less than 60 kg * 750 mg of abatacept for body weight between 60 and 100 kg * 1000 mg of abatacept for body weight greater than 100 kg Abatacept was administered in a 30-minute intravenous infusion.
Age, Categorical <=18 years	1 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Age, Continuous	45.1 years STANDARD_DEVIATION 16.8 • n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	11 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	20 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	20 participants n=99 Participants

PRIMARY outcome

Timeframe: Measured continuously from the screening visit through to the 6 month post-treatment study visit, up to 3 years and 4 months.

Population: This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.

Outcome measures

Outcome measures
Measure	Open-label Abatacept n=20 Participants Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination. Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study: * 500 mg of abatacept for body weight less than 60 kg * 750 mg of abatacept for body weight between 60 and 100 kg * 1000 mg of abatacept for body weight greater than 100 kg Abatacept was administered in a 30-minute intravenous infusion.
Safety of Abatacept - Number of Participants With Adverse Events Serious adverse events	7 participants
Safety of Abatacept - Number of Participants With Adverse Events Non-serious adverse events	16 participants
Safety of Abatacept - Number of Participants With Adverse Events Infection	14 participants
Safety of Abatacept - Number of Participants With Adverse Events Infusion related (systemic)	1 participants
Safety of Abatacept - Number of Participants With Adverse Events Infusion related( intravenous site reaction)	1 participants
Safety of Abatacept - Number of Participants With Adverse Events Cytopenia	4 participants

SECONDARY outcome

Timeframe: Measured monthly until common closing or early termination,up to 3 years and 4 months.

Disease remission was measured by a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 0. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63.

Outcome measures

Outcome measures
Measure	Open-label Abatacept n=20 Participants Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination. Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study: * 500 mg of abatacept for body weight less than 60 kg * 750 mg of abatacept for body weight between 60 and 100 kg * 1000 mg of abatacept for body weight greater than 100 kg Abatacept was administered in a 30-minute intravenous infusion.
Disease Remission	16 participants

SECONDARY outcome

Timeframe: Measured monthly until common closing or early termination, up to 3 years and 4 months.

Disease improvement was measured by a reduction in the Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG). The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63.

Outcome measures

Outcome measures
Measure	Open-label Abatacept n=20 Participants Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination. Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study: * 500 mg of abatacept for body weight less than 60 kg * 750 mg of abatacept for body weight between 60 and 100 kg * 1000 mg of abatacept for body weight greater than 100 kg Abatacept was administered in a 30-minute intravenous infusion.
Disease Improvement	18 participants

SECONDARY outcome

Timeframe: Number assessed at the time of common closing, up to 3 years and 4 months.

The number of subjects that reached the common closing date.

Outcome measures

Outcome measures
Measure	Open-label Abatacept n=20 Participants Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination. Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study: * 500 mg of abatacept for body weight less than 60 kg * 750 mg of abatacept for body weight between 60 and 100 kg * 1000 mg of abatacept for body weight greater than 100 kg Abatacept was administered in a 30-minute intravenous infusion.
Meeting Common Closing	14 participants

SECONDARY outcome

Timeframe: Measured monthly until common closing or early termination, up to 3 years and 4 months.

Disease relapse was measured by a rise in the Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of greater than or equal to 1 after achieving remission. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63.

Outcome measures

Outcome measures
Measure	Open-label Abatacept n=20 Participants Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination. Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study: * 500 mg of abatacept for body weight less than 60 kg * 750 mg of abatacept for body weight between 60 and 100 kg * 1000 mg of abatacept for body weight greater than 100 kg Abatacept was administered in a 30-minute intravenous infusion.
Disease Relapse	3 participants

Adverse Events

Open-label Abatacept

Serious events: 7 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Open-label Abatacept n=20 participants at risk Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination. Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study: * 500 mg of abatacept for body weight less than 60 kg * 750 mg of abatacept for body weight between 60 and 100 kg * 1000 mg of abatacept for body weight greater than 100 kg Abatacept was administered in a 30-minute intravenous infusion.
Infections and infestations Infection - Dental	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Ocular	10.0% 2/20 • Number of events 2 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Lung	5.0% 1/20 • Number of events 2 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Upper airway	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Gastrointestinal	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Respiratory, thoracic and mediastinal disorders Obstruction/stenosis of airway	5.0% 1/20 • Number of events 2 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.

Other adverse events

Other adverse events
Measure	Open-label Abatacept n=20 participants at risk Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination. Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study: * 500 mg of abatacept for body weight less than 60 kg * 750 mg of abatacept for body weight between 60 and 100 kg * 1000 mg of abatacept for body weight greater than 100 kg Abatacept was administered in a 30-minute intravenous infusion.
Immune system disorders Allergy/immunology - Allergic reaction/hypersensitivity	5.0% 1/20 • Number of events 9 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Immune system disorders Allergy/immunology	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Ear and labyrinth disorders Auditory/Ear	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Ear and labyrinth disorders Auditory/Ear - Otitis	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Blood and lymphatic system disorders Blood/Bone marrow - Hemoglobin	10.0% 2/20 • Number of events 2 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Blood and lymphatic system disorders Blood/Bone marrow - Leukocytes	10.0% 2/20 • Number of events 2 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Blood and lymphatic system disorders Blood/Bone marrow - Lymphopenia	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	25.0% 5/20 • Number of events 10 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Skin and subcutaneous tissue disorders Dermatology/Skin - Injection site reaction	5.0% 1/20 • Number of events 2 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Skin and subcutaneous tissue disorders Dermatology/Skin - Photosensitivity	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Endocrine disorders Endocrine - Thyroid function high	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Endocrine disorders Endocrine - Thyroid function low	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Gastrointestinal disorders Gastrointestinal - Other	10.0% 2/20 • Number of events 2 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Gastrointestinal disorders Gastrointestinal - Hemorrhoids	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Gastrointestinal disorders Gastrointestinal - Mucositis/stomatitis	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Other	20.0% 4/20 • Number of events 5 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Abdomen	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Bronchus	10.0% 2/20 • Number of events 2 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Lung	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Middle ear	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Nose	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Sinus	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Skin	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Soft tissue	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Stomach	10.0% 2/20 • Number of events 2 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Upper airway	15.0% 3/20 • Number of events 5 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Infections and infestations Infection - Urinary tract	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Metabolism and nutrition disorders Metabolic/Laboratory - Creatinine	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Metabolism and nutrition disorders Metabolic/Laboratory - Glucose high	5.0% 1/20 • Number of events 6 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Metabolism and nutrition disorders Metabolic/Laboratory - Sodium high	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Metabolism and nutrition disorders Metabolic/Laboratory - Triglyceride high	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue	20.0% 4/20 • Number of events 4 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Eye disorders Ocular/Visual - Other	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Eye disorders Ocular/Visual - Vision blurred	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Eye disorders Ocular/Visual - Vision photophobia	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Eye disorders Ocular/Visual - Watery eye (epiphora, tearing)	10.0% 2/20 • Number of events 2 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
General disorders Pain - Back pain	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper respiratory	20.0% 4/20 • Number of events 5 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper respiratory - Cough	5.0% 1/20 • Number of events 1 • Adverse event data was collected for subjects from time of signed consent through common close out of the study. The total timeframe of adverse event collection for the study was 3 years, 3 months. All serious adverse events related to study participation were reported and were recorded and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) manual v3.0.

Additional Information

Carol A Langford, MD MHS

Vasculitis Clinical Research Consortium

Phone: 216-445-6056

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place