Help us get #EliLilly to disclose the results of their #Tabalumab trial. #PoliticalSpeak #MSBlog
As you are aware we and others hypothesise that MS is caused by a subset of abnormal B-cells that reside in the memory pool. We have developed this hypothesis over many years and it supports the EBV theory of MS. Learning about how MS disease-modifying drugs effects MS is important in supporting, or refuting, our hypothesis. We are particularly interested in the results of the trial below of Tabalumab (LY 2127399) a drug that targets B-cells. Based on other data, and our hypothesis, we predict that this drug will make MS worse, by expanding the particular subset of memory B-cells we are interested in. Predicting worsening of disease is one thing, actually knowing the result of the trial is another thing. MouseDoctor and I have both asked Eli Lilly for the data and they have so far resisted. Is it appropriate for Eli Lilly to keep this data undisclosed?
We note and thank you for you support. We now need to formalise this. You can help us by signing the petition below? The trial involved many sites across the world and if you happen to be a trial participant we would appreciate you telling us. Who knows it may help nudge the Eli Lilly executives to disclose the trial results. Thank you.
Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis
- Phoenix, Arizona, United States, 85013
- Tucson, Arizona, United States, 85741
- Fullerton, California, United States, 92835
- Denver, Colorado, United States, 80220
- Naples, Florida, United States, 34102
- Plantation, Florida, United States, 33324
- Sarasota, Florida, United States, 34239
- Northbrook, Illinois, United States, 60062
- Indianapolis, Indiana, United States, 46202
- Kansas City, Kansas, United States, 66160
- Lexington, Kentucky, United States, 40513
- Biddeford, Maine, United States, 04005
- Farmington Hills, Michigan, United States, 48334
- Toms River, New Jersey, United States, 08755
- Schenectady, New York, United States, 12308
- Charlotte, North Carolina, United States, 28207
- Raleigh, North Carolina, United States, 27607
- Akron, Ohio, United States, 44320
- Green, Ohio, United States, 44685
- Greensburg, Pennsylvania, United States, 15601
- Greenville, South Carolina, United States, 29615
- Franklin, Tennessee, United States, 37064
- Memphis, Tennessee, United States, 38120
- Lubbock, Texas, United States, 79410
- Round Rock, Texas, United States, 78681
- Newport News, Virginia, United States, 23601
- Roanoke, Virginia, United States, 24018
- Sofia, Bulgaria, 1407
- Brno, Czech Republic, 62500
- Pardubice, Czech Republic, 500 05
- Prague, Czech Republic, 140 59
- Caen, France, 14033
- Montpellier, France, 34295
- Nimes, France, 30900
- Strasbourg, France, 67091
- Berlin, Germany, 13156
- Ulm, Germany, 89075
- Budapest, Hungary, 1095
- Gyor, Hungary, 9023
- Gyula, Hungary, 5700
- Tel Hashomer, Israel, 52621
- Gdansk, Poland, 80-952
- Gliwice, Poland, 44-100
- Grodzisk Mazowiecki, Poland, 05-825
- Krakow-Nowa Huta, Poland, PL-31-826
- Lodz, Poland, 90-549
- Lublin, Poland, 20-090
- Targu Mures, Romania, 540136
- Kazan, Russian Federation, 4420029
- Kemerovo, Russian Federation, 650066
- Moscow, Russian Federation, 119435
- Belgrade, Serbia, 11000
- Nis, Serbia, 18000
- Bratislava, Slovakia, 833 05
- Kosice, Slovakia, 04011
- Spisska Nova Ves, Slovakia, 05201
- Zilina, Slovakia, 01001
- Dnepropetrovsk, Ukraine, 49027
- Donetsk, Ukraine, 83037
- Ivano-Frankivsk, Ukraine, 76008
- Kharkiv, Ukraine, 61000
- Vinnytsya, Ukraine, 21005Zaporizhzhya, Ukraine, 69057
Primary Outcome Measures:
- Reduction in cumulative total gadolinium (Gd)-enhancing MRI lesions. [Time Frame: Baseline, 24 weeks ]
Secondary Outcome Measures:
- Total number of Gd-enhancing MRI lesions. [ Time Frame: 4, 8, 12, 16, 20, 24, 30, 36, 42, and 48 weeks ]
- Total number of new or newly enlarging T2-weighted MRI lesions. [ Time Frame: 4, 8, 12, 16, 20, 24, 30, 36, 42, and 48 weeks ]
- Time to first relapse. [ Time Frame: Weeks 24, 48 and period in between. ]
- Proportion of relapse-free subjects. [ Time Frame: Weeks 24, 48 and period in between. ]
- Proportion of subjects with anti-LY2127399 antibodies. [ Time Frame: 24, 48, and 72 weeks ]
- Pharmacodynamics of selected peripheral B cell subsets. [ Time Frame: Week 72 ]
- Serum pharmacokinetics (AUC). [ Time Frame: 42 weeks ]
- Expanded Disability Status Scale (EDSS). [ Time Frame: 12, 24, and 48 weeks ]
- Multiple Sclerosis Functional Composite Scale (MSFC). [ Time Frame: 12, 24, and 48 weeks ]
- Visual Analog Scale (VAS) of Wellbeing. [ Time Frame: 12, 24, and 48 weeks ]
- Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). [ Time Frame: 12, 24, and 48 weeks ]
- 16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16). [ Time Frame: 12, 24, and 48 weeks ]
- Total number of new Gd-enhancing MRI lesions. [ Time Frame: 4, 8, 12, 16, 20, 24, 30, 36, 42, and 48 weeks ]
- Total volume of T2-weighted MRI lesions. [ Time Frame: 4, 8, 12, 16, 20, 24, 30, 36, 42, and 48 weeks ]
- Annualized relapse rate. [ Time Frame: Weeks 24 and 48. ]
Estimated Enrollment: 245
- Study Start Date: April 2009
- Study Completion Date: June 2012
- Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
- Ages Eligible for Study: 18 Years to 64 Years (Adult)
- Sexes Eligible for Study: All
- 18 through 64 years of age diagnosed with relapsing-remitting multiple sclerosis (RRMS), who can walk without aid or rest for at least 200 meters (approximately 1/10 of a mile).
- Women who can become pregnant must use birth control.
- Have had a live vaccination within 12 weeks before randomization, or intend to have a live vaccination during the course of the study.
- Have had had recent surgery or are scheduled to have surgery during the study.
- Are immunocompromised or have evidence of active infection (such as hepatitis, tuberculosis or, human immunodeficiency virus [HIV]).
- Have been on certain drugs that are being studied for RRMS or have recently received prescription drugs to treat RRMS.
- Have had a recent serious infection.
- Have serious or uncontrolled illnesses other than RRMS.
- Have clinically significant blood test values.
- Have multiple or severe drug allergies.
- Have contraindications for magnetic resonance imaging (MRI; "scanning") or claustrophobia (fear of an enclosed space) that cannot be managed.
ClinicalTrials.gov identifier: NCT00882999
Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00882999 History of Changes
Other Study ID Numbers: 12778 H9B-MC-BCDJ
Study First Received: April 16, 2009
Last Updated: June 22, 2012
Baker et al. Memory B Cells are Major Targets for Effective Immunotherapy in Relapsing Multiple Sclerosis. EBioMedicine. 2017 Jan 31. pii: S2352-3964(17)30045-2.
Although multiple sclerosis (MS) is considered to be a CD4, Th17-mediated autoimmune disease, supportive evidence is perhaps circumstantial, often based on animal studies, and is questioned by the perceived failure of CD4-depleting antibodies to control relapsing MS. Therefore, it was interestingly to find that current MS-treatments, believed to act via T cell inhibition, including: beta-interferons, glatiramer acetate, cytostatic agents, dimethyl fumarate, fingolimod, cladribine, daclizumab, rituximab/ocrelizumab physically, or functionally in the case of natalizumab, also depleted CD19+, CD27+ memory B cells. This depletion was substantial and long-term following CD52 and CD20-depletion, and both also induced long-term inhibition of MS with few treatment cycles, indicating induction-therapy activity. Importantly, memory B cells were augmented by B cell activating factor (atacicept) and tumor necrosis factor (infliximab) blockade that are known to worsen MS. This creates a unifying concept centered on memory B cells that is consistent with therapeutic, histopathological and etiological aspects of MS.
Labels: #PoliticalSpeak, B Cells, Eli Lilly, Memory B cells, petition