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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019157-17 | EudraCT Number |
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A Phase 3 study recently reported and demonstrated that the dose of otelixizumab in OTX113390 is not effective.
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The purpose of this study to assess the safety and tolerability of re-dosing at 6 months with otelixizumab (given as an 8-day series of intravenous infusions) in adult subjects with newly diagnosed type 1 diabetes mellitus
The primary objective of this phase IIa, open-label, multi-centre study is to assess the safety, tolerability and immunogenicity of re-dosing at 6 months with an 8 consecutive day series of otelixizumab intravenous (IV) infusions in 8 adult subjects with newly diagnosed type 1 diabetes mellitus (T1DM). Although it is hoped that the β cell preserving effect of otelixizumab will be long-lasting, it is possible that the effect may decline over time and thus T1DM subjects may require re-treatment. Six months is the minimum time expected between treatments.
After baseline assessments, eligible subjects will receive 8 consecutive days of otelixizumab infusions, each given over a 30 minute period. Prophylaxis for cytokine release syndrome AEs will be given. At Month 6, following a review of any new medical conditions, concomitant medications, lymphocyte count, Epstein Barr Virus (EBV) viral load and other re-dosing eligibility criteria, subjects will be re-treated with the same dosing regimen. Subjects will be followed for 24 months in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| otelixizumab | Experimental | otelixizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| otelixizumab | Biological | Two treatment courses of otelixizumab given 6 months apart. Each treatment course will consist of 8 consecutive days of otelixizumab intravenous infusions (each given over 30 minutes). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) | 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. | Up to Month 24 |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | 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. | Baseline and up to Month 24 |
| Mean Change From Baseline in Respiration Rate | 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. | Baseline and up to Month 24 |
| Mean Change From Baseline in Temperature | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Circulating Peripheral T Lymphocytes Count | 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. | Day 1, 4 and 8 of each treatment course |
| Mean Circulating CD4+ and CD8+ Subset Counts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Paris | 75877 | France | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Otelixizumab | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Otelixizumab | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) | 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. | Safety Population consisted of participants who had received at least one dose of infusion. | Posted | Number | Participants | Up to Month 24 |
|
All AEs and SAEs were reported since first dose of investigational product up to Month 24.
Safety Population consisted of participants who had received at least one dose of infusion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Otelixizumab | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C550701 | otelixizumab |
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| Baseline and up to Month 24 |
| Mean Change From Baseline in Heart Rate | 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. | Baseline and up to Month 24 |
| Number of Participants With Values Outside the Normal Range for Vitals | 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. | Up to Month 24 |
| Mean Change From Baseline in Value of Albumin and Total Protein | 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. | Baseline and up to Month 24 |
| 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 | 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. | Baseline and up to Month 24 |
| Mean Change From Baseline in Value of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | 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. | Baseline and up to Month 24 |
| Mean Change From Baseline in Value of Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Magnesium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen | 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. | Baseline and up to Month 24 |
| Mean Change From Baseline in Value of Estradiol | 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. | Baseline and up to Month 24 |
| Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and White Blood Cell Count | 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. | Baseline and up to Month 24 |
| Mean Change From Baseline in Glycosylated Hemoglobin Value | 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. | Baseline and up to Month 24 |
| Mean Change From Baseline in Hemoglobin Value | 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. | Baseline and up to Month 24 |
| Mean Change From Baseline in Red Blood Cell Count | 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. | Baseline and up to Month 24 |
| Mean Epstein-Barr Virus (EBV) Viral Load | 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) | Up to Month 24 |
| Mean Change in Total Lymphocyte Count | Total lymphocyte count was planned to be analyzed up to Month 24. | Baseline and up to Month 24 |
| Mean Change in CD4+ and CD8+ T-cell Counts | 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. | Days 1, 4 and 8 of each treatment course |
| Mean Change in Circulating Peripheral T Lymphocytes | 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. | Days 1, 4 and 8 of each treatment course |
| Mean Change in Circulating Peripheral CD4+ and CD8+ Subset Counts | 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. | Days 1, 4 and 8 of each treatment course |
| Mean Serum Levels of Anti-otelixizumab Binding Antibodies | 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. | Up to Month 24 |
| Proportion of Anti-otelixizumab Neutralizing Antibodies | 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. | Up to Month 24 |
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. |
| Days 1, 4 and 8 of each treatment course |
| Mean Saturation of CD3 Antigen on Peripheral Blood T Cells | 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. | Days 1, 4 and 8 of each treatment course |
| Mean Individual Serum Concentrations of Otelixizumab | Because of the early termination of the study the data was not analyzed. | 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 |
| Maximum Observed Serum Concentration (Cmax) of Otelixizumab | Because of the early termination of the study the data was not analyzed. | 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 |
| Time to Cmax (Tmax) of Otelixizumab | Because of the early termination of the study the data was not analyzed. | 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 |
| Area Under the Serum Concentration-time Curve [AUC(0-tlast)] of Otelixizumab | Because of the early termination of the study the data was not analyzed. | 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 |
| Time of Last Observed Quantifiable Concentration (Tlast) of Otelixizumab | Because of the early termination of the study the data was not analyzed. | 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 |
| Terminal Phase Half-life (Thalf) of Otelixizumab | Because of the early termination of the study the data was not analyzed. | 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 |
| Leipzig |
| Saxony |
| 04103 |
| Germany |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Otelixizumab | 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. |
|
|
| Primary | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | 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. | Safety Population. Because of the early termination of the study the data was not collected. | Posted | Baseline and up to Month 24 |
|
|
| Primary | Mean Change From Baseline in Respiration Rate | 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. | Safety Population. Because of the early termination of the study the data was not collected. | Posted | Baseline and up to Month 24 |
|
|
| Primary | Mean Change From Baseline in Temperature | 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. | Safety Population. Because of the early termination of the study the data was not collected. | Posted | Baseline and up to Month 24 |
|
|
| Primary | Mean Change From Baseline in Heart Rate | 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. | Safety Population. Because of the early termination of the study the data was not collected. | Posted | Baseline and up to Month 24 |
|
|
| Primary | Number of Participants With Values Outside the Normal Range for Vitals | 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. | Safety Population | Posted | Number | Participants | Up to Month 24 |
|
|
|
| Primary | Mean Change From Baseline in Value of Albumin and Total Protein | 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. | Safety Population. Because of the early termination of the study the data was not collected. | Posted | Baseline and up to Month 24 |
|
|
| Primary | 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 | 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. | Safety Population. Because of the early termination of the study the data was not collected. | Posted | Baseline and up to Month 24 |
|
|
| Primary | Mean Change From Baseline in Value of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | 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. | Safety Population. Because of the early termination of the study the data was not collected. | Posted | Baseline and up to Month 24 |
|
|
| Primary | Mean Change From Baseline in Value of Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Magnesium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen | 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. | Safety Population. Because of the early termination of the study the data was not collected. | Posted | Baseline and up to Month 24 |
|
|
| Primary | Mean Change From Baseline in Value of Estradiol | 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. | Safety Population. Because of the early termination of the study the data was not collected. | Posted | Baseline and up to Month 24 |
|
|
| Primary | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and White Blood Cell Count | 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. | Safety Population. Because of the early termination of the study the data was not collected. | Posted | Baseline and up to Month 24 |
|
|
| Primary | Mean Change From Baseline in Glycosylated Hemoglobin Value | 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. | Safety Population. Because of the early termination of the study the data was not collected. | Posted | Baseline and up to Month 24 |
|
|
| Primary | Mean Change From Baseline in Hemoglobin Value | 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. | Safety Population. Because of the early termination of the study the data was not collected. | Posted | Baseline and up to Month 24 |
|
|
| Primary | Mean Change From Baseline in Red Blood Cell Count | 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. | Safety Population. Because of the early termination of the study the data was not collected. | Posted | Baseline and up to Month 24 |
|
|
| Primary | Mean Epstein-Barr Virus (EBV) Viral Load | 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) | Safety Population | Posted | Mean | Standard Deviation | Copies per 10^6 PBMCs | Up to Month 24 |
|
|
|
| Primary | Mean Change in Total Lymphocyte Count | Total lymphocyte count was planned to be analyzed up to Month 24. | Safety Population. Because of the early termination of the study this endpoint was not collected. | Posted | Baseline and up to Month 24 |
|
|
| Primary | Mean Change in CD4+ and CD8+ T-cell Counts | 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. | Safety Population | Posted | Mean | Standard Deviation | Percent total lymphocytes | Days 1, 4 and 8 of each treatment course |
|
|
|
| Primary | Mean Change in Circulating Peripheral T Lymphocytes | 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. | Safety Population | Posted | Mean | Standard Deviation | GI/L | Days 1, 4 and 8 of each treatment course |
|
|
|
| Primary | Mean Change in Circulating Peripheral CD4+ and CD8+ Subset Counts | 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. | Safety Population | Posted | Mean | Standard Deviation | Percent total lymphocytes | Days 1, 4 and 8 of each treatment course |
|
|
|
| Primary | Mean Serum Levels of Anti-otelixizumab Binding Antibodies | 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. | Safety Population. Because of the early termination of the study the data was not collected. | Posted | Up to Month 24 |
|
|
| Primary | Proportion of Anti-otelixizumab Neutralizing Antibodies | 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. | Safety Population. Because of the early termination of the study the data was not collected. | Posted | Up to Month 24 |
|
|
| Secondary | Mean Circulating Peripheral T Lymphocytes Count | 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. | Safety Population | Posted | Mean | Standard Deviation | GI/L | Day 1, 4 and 8 of each treatment course |
|
|
|
| Secondary | Mean Circulating CD4+ and CD8+ Subset Counts | 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. | Safety Population | Posted | Mean | Standard Deviation | Percent total lymphocytes | Days 1, 4 and 8 of each treatment course |
|
|
|
| Secondary | Mean Saturation of CD3 Antigen on Peripheral Blood T Cells | 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. | Safety Population | Posted | Mean | Standard Deviation | MESF | Days 1, 4 and 8 of each treatment course |
|
|
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| Secondary | Mean Individual Serum Concentrations of Otelixizumab | Because of the early termination of the study the data was not analyzed. | Safety Population | Posted | Mean | Standard Deviation | Nanograms per milliliter (ng/mL) | 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 |
|
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) of Otelixizumab | Because of the early termination of the study the data was not analyzed. | Safety Population | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
|
|
| Secondary | Time to Cmax (Tmax) of Otelixizumab | Because of the early termination of the study the data was not analyzed. | Safety Population | Posted | Median | Full Range | hours | 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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| Secondary | Area Under the Serum Concentration-time Curve [AUC(0-tlast)] of Otelixizumab | Because of the early termination of the study the data was not analyzed. | Safety Population | Posted | Mean | Standard Deviation | Hours times nanograms per milliliter | 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 |
|
|
|
| Secondary | Time of Last Observed Quantifiable Concentration (Tlast) of Otelixizumab | Because of the early termination of the study the data was not analyzed. | Safety Population | Posted | Median | Full Range | hours | 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 |
|
|
|
| Secondary | Terminal Phase Half-life (Thalf) of Otelixizumab | Because of the early termination of the study the data was not analyzed. | Safety Population | Posted | Median | Full Range | hours | 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 |
|
|
|
| 0 |
| 1 |
| 1 |
| 1 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
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.
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Temperature |
|