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Myasthaenia GravisPhase 2NCT01480596

The Evaluation of Belimumab in Myasthenia Gravis (MG)

A Phase 2 study testing Belimumab in people with Myasthaenia Gravis, run by GlaxoSmithKline at 25 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myasthaenia Gravis
What is being tested?
Belimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
25 sitesin 4 countries
Study dates
Apr 2013to Oct 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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%).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

25 sites in 4 countries.

25 sites in 4 countries

United States15 sites

  • GSK Investigational Site

    Burlington, Vermont, 05405

  • GSK Investigational Site

    Chapel Hill, North Carolina

  • GSK Investigational Site

    Charleston, South Carolina, 29425

  • GSK Investigational Site

    Charlottesville, Virginia, 22908

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Columbus, Ohio, 43210

  • GSK Investigational Site

    Hershey, Pennsylvania, 17033-0859

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Kansas City, Kansas, 66160

  • GSK Investigational Site

    Los Angeles, California, 90033

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    Phoenix, Arizona, 85018

  • GSK Investigational Site

    Tampa, Florida, 33612

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20037

Other trials in United States

Canada4 sites

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2B7

  • GSK Investigational Site

    London, Ontario, N6A 5A5

  • GSK Investigational Site

    Toronto, Ontario, M5G 2C4

  • GSK Investigational Site

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

Germany4 sites

  • GSK Investigational Site

    Berlin, State of Berlin, 10117

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50924

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Italy2 sites

  • GSK Investigational Site

    Milan, Lombardy, 20133

  • GSK Investigational Site

    Rome, Lazio, 00185

Other trials in Italy

About this study

Official title: 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.

Being tested
Belimumab, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BelimumabBiological

    10mg/kg IV infusion

  • PlaceboOther

    placebo IV infusion

Study groups in NCT01480596
Study groupRoleWhat they receive
BelimumabExperimental10mg/kg
Receives: Biological: Belimumab
PlaceboPlacebo comparatorplacebo IV infusion
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline for Quantitative Myasthenia Gravis (QMG) Score at 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.

    Measured: Baseline and Week 24

Secondary outcomes (18)

  1. Number of Participants With Improvement by Greater Than or Equal to (>=) 3 Points From Baseline Through to Week 24 in the QMG Score

    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.

    Measured: Baseline and up to Week 24

  2. Number of Participants Worsening by >=3 Points in QMG Score From Baseline Through 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.

    Measured: Baseline and up to Week 24

  3. Number of Participants With a Sustained Response in the QMG Score

    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.

    Measured: Baseline and up to Week 24

  4. 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

    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.

    Measured: Baseline and up to Week 24

  5. Mean Change From Baseline for QMG Score at 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.

    Measured: Baseline, Week 28, Week 32 and Week 36

  6. Mean Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Through 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.

    Measured: Baseline and up to Week 24

  7. Number of Participants With Improvement by >=3 Points From Baseline Through to Week 24 in the MGC Score

    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.

    Measured: Baseline and up to Week 24

  8. Number of Participants Worsening by >=3 Points From Baseline Through to Week 24 in the MGC Score

    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.

    Measured: Baseline and up to Week 24

  9. Number of Participants With a Sustained Response in the MGC Score

    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.

    Measured: Baseline and up to Week 24

  10. 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

    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.

    Measured: Baseline and up to Week 24

  11. Mean Change From Baseline for MGC Score at 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.

    Measured: Baseline, Week 28, Week 32 and Week 36

  12. 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.

    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.

    Measured: Week 24 and Week 36

  13. Number of Participants With MGFA-PIS of Pharmacologic Remission or Better at 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.

    Measured: Week 24 and Week 36

  14. Number of Participants With MGFA-PIS of Minimal Manifestation Sustained Response (MM at Week 12 and Maintained the Response 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.

    Measured: Week 12 through Week 24

  15. Number of Participants With MGFA-PIS of Pharmacologic Response Sustained Response (PR at Week 12 and Maintained the Response 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.

    Measured: Week 12 through Week 24

  16. Number of Participants With MGFA-PIS (Unchanged, Improved, Worsened) at 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.

    Measured: Week 24 and Week 36

  17. Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at 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.

    Measured: Baseline, Week 12 and Week 24

  18. Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at 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.

    Measured: Baseline, Week 28, Week 32 and Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2011 (estimated)
  2. Study startApr 2013
  3. Primary completionAug 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01480596
Sponsor's protocol ID
115123
Status last verified
Dec 2016
First submitted
27 Oct 2011
Last updated
9 Feb 2017
Data monitoring committee
No

Publications

  • Hewett K, Sanders DB, Grove RA, Broderick CL, Rudo TJ, Bassiri A, Zvartau-Hind M, Bril V; BEL115123 Study Group. Randomized study of adjunctive belimumab in participants with generalized myasthenia gravis. Neurology. 2018 Apr 17;90(16):e1425-e1434. doi: 10.1212/WNL.0000000000005323. Epub 2018 Mar 21.

    PubMed 29661905

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Belimumab in people with Myasthaenia Gravis, run by GlaxoSmithKline at 25 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Canada, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline for Quantitative Myasthenia Gravis (QMG) Score at Week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01480596, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.

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