The Evaluation of Belimumab in Myasthenia Gravis (MG)

December 15, 2016 updated by: GlaxoSmithKline

A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects With Generalized Myasthenia Gravis (MG)

Study BEL115123 is a randomized, placebo-controlled, double-blind, multinational study of belimumab (10 mg/kg) to investigate the efficacy and safety of belimumab in subjects with MG. The study will enroll male and female outpatients (> or equal to 18 years of age) with a diagnosis of MG who are 1) acetylcholine receptor (AChR) antibody positive or muscle specific kinase (MuSK) antibody positive, 2) on current standard of care therapy, and 3) continue to exhibit signs of MG. The study will include 3 phases: a 4 week screening period, a 24 week treatment period, and a 12 week follow-up period. IP will be administered intravenously on Days 0, 14, 28 and then every 28 days through and including Week 20. At Week 24, primary outcomes will be obtained. Follow up evaluations will be conducted at Weeks 28, 32 and 36 for all subjects. The primary objective of this study is to assess the efficacy of belimumab as evaluated by the change in the quantitative myasthenia gravis (QMG) score.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • GSK Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • GSK Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 2C4
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Tuebingen, Baden-Wuerttemberg, Germany, 72076
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Koeln, Nordrhein-Westfalen, Germany, 50924
        • GSK Investigational Site
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • GSK Investigational Site
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00185
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, Italy, 20133
        • GSK Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • GSK Investigational Site
    • California
      • Los Angeles, California, United States, 90033
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • GSK Investigational Site
    • Florida
      • Miami, Florida, United States, 33136
        • GSK Investigational Site
      • Tampa, Florida, United States, 33612
        • GSK Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • GSK Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • GSK Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0859
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • GSK Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
    • Vermont
      • Burlington, Vermont, United States, 05405
        • GSK Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years and older, with life expectancy of greater than 1 year.
  • MG of class II to IVa inclusive.
  • Acetylcholine receptor (AChR) or muscle specific kinase (MuSK) antibody positive.
  • Stable dose (defined as no dose changes) not exceeding the maximum doses given in Section 5.6.1 of the following therapy(ies) prior to screening: Cholinesterase inhibitor(pyridostigmine or equivalent) for at least 2 weeks prior to screening and no immunosuppressants; Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to screening and/or only one of the following: prednisone (up to 40 mg/day or equivalent) for at least 1 month prior to screening; azathioprine for at least 6 months prior to screening; mycophenolate for at least 6 months prior to screening, or cyclosporine for at least 3 months prior to screening; or Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to screening and/or prednisone (up to 20 mg/day or equivalent) for at least 1 month prior to screening and only one of the following: azathioprine for at least 6 months prior to screening, mycophenolate for at least 6 months prior to screening, or cyclosporine for at least 3 months prior to screening
  • Quantitative Myasthenia Gravis (QMG) score of 8 or greater, with at least 4 points derived from signs other than ocular
  • A female subject is eligible to participate if she is: Of non-childbearing potential; Of childbearing potential and NOT pregnant or nursing, has a negative serum pregnancy test at screening, and agrees to one of the following: Complete abstinence from penile-vaginal intercourse, when this is the female's preferred and usual lifestyle, for the period from consent into the study until 16 weeks after the last dose of investigational product; or Consistent and correct use of one of the following acceptable methods of birth control for the period from consent into the study until 16 weeks after the last dose of investigational product: Oral contraceptives (either combined or progesterone only), Injectable progesterone, Implants of etonogestrel or levonorgestrel, Estrogenic vaginal ring, Percutaneous contraceptive patches, Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year, Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study; this male must be the sole partner for the subject, Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Single QTc less than 450 msec; or QTc less than 480 msec in subjects with Bundle Branch Block.
  • AST and ALT less than 2xULN; alkaline phosphatase and bilirubin less or = to 1.5xULN (isolated bilirubin greater than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).

Exclusion Criteria:

  • Participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) prior to screening or planning to take any investigational drug for the planned duration of study participation (6 months after the last dose of study drug).
  • Presence or previous history of thymoma.
  • Thymectomy within 12 months
  • Clinically significant (in the opinion of investigator) abnormal laboratory values.
  • Pregnant females as determined by positive (serum) hCG test at screening or prior to dosing, or lactating females or planning to become pregnant within 16 weeks after last dose of investigational product.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
  • May require (in the opinion of investigator) treatment with IVIg and/or plasmapheresis during the 24 week treatment period.
  • Have received IVIg and/or plasmapheresis within 90 days prior to screening.
  • Have received any other biopharmaceutical agent (except IVIg as described in exclusion criteria #8) in the 364 days prior to screening.
  • Have received treatment with any B cell targeted therapy (e.g., rituximab, belimumab), at any time.
  • Have received a live vaccine within 30 days of study Day 0 (baseline).
  • Have received cyclophosphamide or any other immunosuppressive agent apart from the ones allowed by the inclusion criteria #4, within the past 6 months.
  • Have another medical condition that requires treatment with steroids or immunosuppressive agents.
  • Hospitalization due to infection or use of parenteral antibacterial, antifungal or antiviral agents within 60 days prior to screening; or history of recurrent or chronic infection, or currently active systemic infection.
  • Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
  • Have a history of a major organ transplant (eg, heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
  • Have a historically positive test or test positive at screening for HIV-1, hepatitis B surface antigen or hepatitis C antibody.
  • Have an IgG Grade 3 or greater deficiency (less than or = to 400mg/dL).
  • Have an IgA deficiency (IgA less than 10mg/dL).
  • Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
  • Has a progressive medical, neurological or psychological condition or situation that, in the investigator's judgment, is likely to cause the subject to be unable or unwilling to participate in study procedures, to complete all scheduled assessments, or precludes accurate assessments.
  • Is currently abusing drugs or alcohol or has history of abuse in the last 12 months.
  • Subjects who have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation of type 4 or 5 on the C-SSRS in the last 2 months or who in the investigator's judgment, pose a significant suicide risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Belimumab
10mg/kg
Biological: Belimumab
10mg/kg IV infusion
Placebo Comparator: Placebo
placebo IV infusion
Other: Placebo
placebo IV infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline for Quantitative Myasthenia Gravis (QMG) Score at Week 24
Time Frame: Baseline and Week 24
The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means were presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline QMG Score, Treatment by Visit, and Baseline QMG Score by Visit.
Baseline and Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Improvement by Greater Than or Equal to (>=) 3 Points From Baseline Through to Week 24 in the QMG Score
Time Frame: Baseline and up to Week 24
The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Proportions compared using exact analyses stratified by the observed median Baseline score (less than or equal to [<=] median, greater than [ >] median). Exact odds ratio, double the exact one-sided p-value and exact confidence intervals were presented. Participants with missing data were assumed to have a negative response.
Baseline and up to Week 24
Number of Participants Worsening by >=3 Points in QMG Score From Baseline Through to Week 24
Time Frame: Baseline and up to Week 24
The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Proportions compared using exact analyses stratified by the observed median Baseline score (<=median, > median). Exact odds ratio, double the exact one-sided p-value and exact confidence interval were presented. Participants with missing data were assumed to have a worsening response.
Baseline and up to Week 24
Number of Participants With a Sustained Response in the QMG Score
Time Frame: Baseline and up to Week 24
A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Odds ratios are calculated by Cochran-Mantel-Haenszel method stratified by the observed median baseline score (<= median, > median). Wald confidence intervals and p-values were presented.
Baseline and up to Week 24
Median Time to QMG Response Which is Sustained From Earliest Time Point at Which Improvement by >=3 Points From Baseline is Observed and Maintained Through Week 24
Time Frame: Baseline and up to Week 24
A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores.
Baseline and up to Week 24
Mean Change From Baseline for QMG Score at Week 28, Week 32 and Week 36
Time Frame: Baseline, Week 28, Week 32 and Week 36
The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. Total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (mild) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at baseline (BL) is the average of the screening and Week 0 BL scores. Change from BL was calculated by subtracting the BL value from the post-BL value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative trt difference indicates benefit relative to placebo. Analysis method was Mixed-Model Repeated Measures adjusted for Trt, Visit, BL QMG Score, Trt by Visit and BL QMG Score by Visit. Only follow-up visits are presented but the analysis also includes all trt phase visits. Only those par. available at indicated time points (represented by n=X in the category titles) were analyzed.
Baseline, Week 28, Week 32 and Week 36
Mean Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Through to Week 24
Time Frame: Baseline and up to Week 24
The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MGC Score, Treatment by Visit, and Baseline MGC Score by Visit.
Baseline and up to Week 24
Number of Participants With Improvement by >=3 Points From Baseline Through to Week 24 in the MGC Score
Time Frame: Baseline and up to Week 24
The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Proportions compared using exact analyses stratified by the observed median baseline score (<= median, > median). Exact odds ratios, double the exact one-sided p-values and exact confidence intervals were presented. Participants with missing data were assumed to have a negative response.
Baseline and up to Week 24
Number of Participants Worsening by >=3 Points From Baseline Through to Week 24 in the MGC Score
Time Frame: Baseline and up to Week 24
The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Proportions compared using exact analyses stratified by the observed median baseline score (<= median, > median). Exact odds ratios, double the exact one-sided p-values and exact confidence intervals were presented. Participants with missing data were assumed to have a worsening response.
Baseline and up to Week 24
Number of Participants With a Sustained Response in the MGC Score
Time Frame: Baseline and up to Week 24
AA sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Odds ratios are calculated by Cochran-Mantel-Haenszel method without adjusting for any strata. Wald confidence intervals and p-values were presented.
Baseline and up to Week 24
Median Time to MGC Response Which is Sustained From Earliest Time Point at Which Improvement by >=3 Points From Baseline is Observed and Maintained Through Week 24
Time Frame: Baseline and up to Week 24
A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants' last available assessment prior to initiation of study intravenous (IV) infusion.
Baseline and up to Week 24
Mean Change From Baseline for MGC Score at Week 28, Week 32 and Week 36
Time Frame: Baseline, Week 28, Week 32 and Week 36
The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participant's last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-BL value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MGC Score, Treatment by Visit, and Baseline MGC Score by Visit. Only follow-up visits are presented but the analysis also includes all treatment phase visits. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.
Baseline, Week 28, Week 32 and Week 36
Number of Participants With a Myasthenia Foundation of America-post Intervention Status (MGFA-PIS) of Minimal Manifestation or Better at Week 24 and Week 36.
Time Frame: Week 24 and Week 36
Myasthenia Foundation of America-post intervention status assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.
Week 24 and Week 36
Number of Participants With MGFA-PIS of Pharmacologic Remission or Better at Week 24 and Week 36
Time Frame: Week 24 and Week 36
Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.
Week 24 and Week 36
Number of Participants With MGFA-PIS of Minimal Manifestation Sustained Response (MM at Week 12 and Maintained the Response Through Week 24)
Time Frame: Week 12 through Week 24
Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.
Week 12 through Week 24
Number of Participants With MGFA-PIS of Pharmacologic Response Sustained Response (PR at Week 12 and Maintained the Response Through Week 24)
Time Frame: Week 12 through Week 24
Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.
Week 12 through Week 24
Number of Participants With MGFA-PIS (Unchanged, Improved, Worsened) at Week 24 and Week 36
Time Frame: Week 24 and Week 36
Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being unchanged, improved or worsened.
Week 24 and Week 36
Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 12 and Week 24
Time Frame: Baseline, Week 12 and Week 24
The total MG-ADL score was calculated by adding the score of each of the 8 individual MG-ADL questions. Possible total MG-ADL scores ranges from 0 (normal) to 24 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MG-ADL Score, Treatment by Visit, and Baseline MG-ADL Score by Visit. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.
Baseline, Week 12 and Week 24
Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 28, Week 32 and Week 36
Time Frame: Baseline, Week 28, Week 32 and Week 36
The total MG-ADL score was calculated by adding the score of each of the 8 individual MG-ADL questions. Possible total MG-ADL scores range from 0 (normal) to 24 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participant's last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MG-ADL Score, Treatment by Visit, and Baseline MG-ADL Score by Visit. Only follow-up visits are presented but the analysis also includes all treatment phase visits. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.
Baseline, Week 28, Week 32 and Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 115123

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