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Investigating Re-Dosing With Otelixizumab in Adults With Newly-Diagnosed Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01222078
Recruitment Status : Terminated (A Phase 3 study recently reported and demonstrated that the dose of otelixizumab in OTX113390 is not effective.)
First Posted : October 18, 2010
Results First Posted : June 16, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Intervention Biological: otelixizumab
Enrollment 1
Recruitment Details The study was conducted at one site in France during the period 22 November 2010 to 19 May 2011 and was planned to enroll 8 participants. But only one participant was enrolled and received a single course of study medication. No participants were re-dosed.
Pre-assignment Details  
Arm/Group Title Otelixizumab
Hide Arm/Group Description Participant received a single dose of otelixizumab intravenous (IV) infusions each given over a 30 minute period on 8 consecutive days in order: 0.1 milligrams (mg), 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before start of infusion (SOI), 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Early termination of the study             1
Arm/Group Title Otelixizumab
Hide Arm/Group Description Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
31 [1]   (NA)
[1]
Only one participant enrolled
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)
Hide Description AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Study was early terminated and participant withdrew on study Day 164.
Time Frame Up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population consisted of participants who had received at least one dose of infusion.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Participants
Any AEs 1
Any SAEs 0
2.Primary Outcome
Title Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Hide Description Blood pressure was assessed at sitting position at Baseline and 1 to 7 hours of post-infusion of first treatment period. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Time Frame Baseline and up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study the data was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Mean Change From Baseline in Respiration Rate
Hide Description Respiration rate was assessed at sitting position at Baseline and post-treatment. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Time Frame Baseline and up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study the data was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Mean Change From Baseline in Temperature
Hide Description Temperature was recorded at sitting position at Baseline and post treatment. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Time Frame Baseline and up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study the data was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Primary Outcome
Title Mean Change From Baseline in Heart Rate
Hide Description Heart rate was recorded at sitting position at Baseline and post-treatment period. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Time Frame Baseline and up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study the data was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Number of Participants With Values Outside the Normal Range for Vitals
Hide Description Vital included assessment of SBP, DBP, respiration rate, heart rate and temperature were assessed at sitting position. Participant did not received re-dose of second treatment period and withdrew on study Day 164 because of early study termination.
Time Frame Up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Participants
SBP and DBP 1
Respiration rate 1
Heart rate 1
Temperature 0
7.Primary Outcome
Title Mean Change From Baseline in Value of Albumin and Total Protein
Hide Description Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Time Frame Baseline and up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study the data was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Primary Outcome
Title Mean Change From Baseline in Value of Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Follicle Stimulating Hormone, Gamma Glutamyl Tranferase and Lactate Dehydrogenase
Hide Description Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Time Frame Baseline and up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study the data was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Primary Outcome
Title Mean Change From Baseline in Value of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid
Hide Description Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Time Frame Baseline and up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study the data was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Primary Outcome
Title Mean Change From Baseline in Value of Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Magnesium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen
Hide Description Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Time Frame Baseline and up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study the data was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Primary Outcome
Title Mean Change From Baseline in Value of Estradiol
Hide Description Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Time Frame Baseline and up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study the data was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Primary Outcome
Title Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and White Blood Cell Count
Hide Description Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Time Frame Baseline and up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study the data was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
13.Primary Outcome
Title Mean Change From Baseline in Glycosylated Hemoglobin Value
Hide Description Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Time Frame Baseline and up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study the data was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
14.Primary Outcome
Title Mean Change From Baseline in Hemoglobin Value
Hide Description Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Time Frame Baseline and up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study the data was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
15.Primary Outcome
Title Mean Change From Baseline in Red Blood Cell Count
Hide Description Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Time Frame Baseline and up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study the data was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
16.Primary Outcome
Title Mean Epstein-Barr Virus (EBV) Viral Load
Hide Description Levels of EBV were assessed periodically using Quantitative Polymerase Chain Reaction. If a participant had an EBV viral load of >=10,000 copies per 10^6 Peripheral Blood Mononuclear Cells (PBMCs) at any visit, the test was repeated as soon as possible to confirm this result. If the result was confirmed, the test was repeated weekly for 2 weeks or until the count decreases to < 10,000 copies per 10^6 PBMCs, whichever was longer. The EBV Load remained zero throughout the study. Participant did not received re-dose of second treatment period and withdrew on study Day 164 because of early study termination. The viral load was to measure using unit copies per 10^6 Peripheral Blood Mononuclear Cells (PBMCs)
Time Frame Up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: Copies per 10^6 PBMCs
0 [1]   (NA)
[1]
The value remained zero throughout the study
17.Primary Outcome
Title Mean Change in Total Lymphocyte Count
Hide Description Total lymphocyte count was planned to be analyzed up to Month 24.
Time Frame Baseline and up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study this endpoint was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
18.Primary Outcome
Title Mean Change in CD4+ and CD8+ T-cell Counts
Hide Description CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.
Time Frame Days 1, 4 and 8 of each treatment course
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: Percent total lymphocytes
NA [1]   (NA)
[1]
As study was early terminated, data was not analyzed
19.Primary Outcome
Title Mean Change in Circulating Peripheral T Lymphocytes
Hide Description Circulating peripheral T lymphocytes were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.
Time Frame Days 1, 4 and 8 of each treatment course
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: GI/L
NA [1]   (NA)
[1]
As study was early terminated, data was not analyzed.
20.Primary Outcome
Title Mean Change in Circulating Peripheral CD4+ and CD8+ Subset Counts
Hide Description Circulating peripheral CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.
Time Frame Days 1, 4 and 8 of each treatment course
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: Percent total lymphocytes
NA [1]   (NA)
[1]
As study was early terminated, data was not analyzed
21.Primary Outcome
Title Mean Serum Levels of Anti-otelixizumab Binding Antibodies
Hide Description Antibodies to otelixizumab were planned to be measured at Baseline and at specified post-Baseline visits using a validated immunoassay. If a positive result was detected, the samples were analyzed further in a neutralizing antibody assay to determine if the antibodies were neutralizing. The 12 and 24 month samples were only be taken if a participant had a positive result for antibodies at the last tested time point (Month 9) or if the Month 9 test results were not available.
Time Frame Up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study the data was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
22.Primary Outcome
Title Proportion of Anti-otelixizumab Neutralizing Antibodies
Hide Description Antibodies to otelixizumab were planned to be measured at Baseline and at specified post-Baseline visits using a validated immunoassay. If a positive result was detected, the samples were analyzed further in a neutralizing antibody assay to determine if the antibodies were neutralizing. The 12 and 24 month samples were only be taken if a participant had a positive result for antibodies at the last tested time point (Month 9) or if the Month 9 test results were not available.
Time Frame Up to Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Because of the early termination of the study the data was not collected.
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Mean Circulating Peripheral T Lymphocytes Count
Hide Description Circulating peripheral T lymphocytes were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.
Time Frame Day 1, 4 and 8 of each treatment course
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Safety Population
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: GI/L
NA [1]   (NA)
[1]
As study was early terminated, data was not analyzed
24.Secondary Outcome
Title Mean Circulating CD4+ and CD8+ Subset Counts
Hide Description Circulating peripheral CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.
Time Frame Days 1, 4 and 8 of each treatment course
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Safety Population
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: Percent total lymphocytes
NA [1]   (NA)
[1]
As study was early terminated, data was not analyzed
25.Secondary Outcome
Title Mean Saturation of CD3 Antigen on Peripheral Blood T Cells
Hide Description Assessment of CD3 antigen was planned to be done on Day 1, 4 and 8 of first treatment course. The data was planned to be presented with unit Molecules of Equivalent Soluble Fluorochrome (MESF). Because of the early termination of the study the data was not analyzed.
Time Frame Days 1, 4 and 8 of each treatment course
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Safety Population
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: MESF
NA [1]   (NA)
[1]
As study was early terminated, data was not analyzed
26.Secondary Outcome
Title Mean Individual Serum Concentrations of Otelixizumab
Hide Description Because of the early termination of the study the data was not analyzed.
Time Frame Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course
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Safety Population
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: Nanograms per milliliter (ng/mL)
NA [1]   (NA)
[1]
As study was early terminated, data was not analyzed
27.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of Otelixizumab
Hide Description Because of the early termination of the study the data was not analyzed.
Time Frame Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course
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Safety Population
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: ng/mL
NA [1]   (NA)
[1]
As study was early terminated, data was not analyzed
28.Secondary Outcome
Title Time to Cmax (Tmax) of Otelixizumab
Hide Description Because of the early termination of the study the data was not analyzed.
Time Frame Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course
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Safety Population
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 1
Median (Full Range)
Unit of Measure: hours
NA [1] 
(NA to NA)
[1]
Value could not be determined due to insufficient quantifiable concentrations and the study was early terminated.
29.Secondary Outcome
Title Area Under the Serum Concentration-time Curve [AUC(0-tlast)] of Otelixizumab
Hide Description Because of the early termination of the study the data was not analyzed.
Time Frame Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course
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Safety Population
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: Hours times nanograms per milliliter
NA [1]   (NA)
[1]
Value could not be determined due to insufficient quantifiable concentrations and the study was early terminated.
30.Secondary Outcome
Title Time of Last Observed Quantifiable Concentration (Tlast) of Otelixizumab
Hide Description Because of the early termination of the study the data was not analyzed.
Time Frame Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course
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Safety Population
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 1
Median (Full Range)
Unit of Measure: hours
NA [1] 
(NA to NA)
[1]
Value could not be determined due to insufficient quantifiable concentrations and the study was early terminated.
31.Secondary Outcome
Title Terminal Phase Half-life (Thalf) of Otelixizumab
Hide Description Because of the early termination of the study the data was not analyzed.
Time Frame Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course
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Safety Population
Arm/Group Title Otelixizumab
Hide Arm/Group Description:
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
Overall Number of Participants Analyzed 1
Median (Full Range)
Unit of Measure: hours
NA [1] 
(NA to NA)
[1]
Value could not be determined due to insufficient quantifiable concentrations and the study was early terminated.
Time Frame All AEs and SAEs were reported since first dose of investigational product up to Month 24.
Adverse Event Reporting Description Safety Population consisted of participants who had received at least one dose of infusion.
 
Arm/Group Title Otelixizumab
Hide Arm/Group Description Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
All-Cause Mortality
Otelixizumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Otelixizumab
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Otelixizumab
Affected / at Risk (%)
Total   1/1 (100.00%) 
Gastrointestinal disorders   
Dyspepsia  1  1/1 (100.00%) 
General disorders   
Pyrexia  1  1/1 (100.00%) 
Nervous system disorders   
Headache  1  1/1 (100.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/1 (100.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary with a conclusion.
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01222078     History of Changes
Other Study ID Numbers: 113390
First Submitted: October 7, 2010
First Posted: October 18, 2010
Results First Submitted: April 3, 2017
Results First Posted: June 16, 2017
Last Update Posted: August 25, 2017