A Prospective Biomarker Study in Active SPMS Subjects Treated With Cladribine Tablets

NCT04550455 | Unknown Phase 4 FDA Drug

• 1 other identifier: Cladribine-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the concept that biomarker sensitivity will detect activity in Multiple Sclerosis (MS) subjects and allow appropriate change in treatment to prevent dysfunction.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Time to achieve no evidence of disease activity (NEDA) -4 compared to baseline

  Currently accepted NEDA -3 criteria of 1) no clinical relapses 2) No new or newly enlarging MRI lesions 3) No progression of disability as measured by the expanded disability status scale (EDSS) with 4) the addition of no increase of serum and/or cerebrospinal fluid (CSF) and/or neurofilament light chain (NfL).

  96 weeks

• Decrease of serum/CSF NfL

  Estimate of the change in serum/CSF NfL values from pre-treatment level to week 48

  48 weeks

Secondary Outcomes (2)

• Change in upper body function

  96 weeks

• Change in Cognitive Function

  96 weeks

Other Outcomes (2)

• CSF/serum glial fibrillary acidic protein (GFAP)

  96 weeks

• CSF/serum NfL antibody as markers for progressive multiple sclerosis (PMS)

  96 weeks

Study Arms (1)

Cladribine Tablets

EXPERIMENTAL

All participants will receive cladribine tablets according to the current United States Federal Food and Drug Administration (FDA) package guidelines.

Drug: Cladribine Tablets

Interventions

Cladribine Tablets DRUG

Cladribine tablets will be administered according the current package insert guidelines

Also known as: Mavenclad

Cladribine Tablets

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between 21 and 65 years old, inclusive.
• Must be capable of understanding and providing written informed consent, including subject authorization under the health insurance portability and accountability act (HIPPA), prior to any study related procedures that are not part of routine medical care.
• Has an EDSS score at the screening visit of 2.0 to 7.0 inclusive.
• Have a diagnosis of clinically definite SPMS. (Lublin, 2014)
• Are considered neurologically stable for \> 30 days prior to both screening, baseline and week 48.
• Must be otherwise healthy without confounding diseases.
• Subject has decided to pursue cladribine tablets as their disease modifying therapy (DMT) of choice, and have signed a study specific informed consent form.
• Must be willing and physically able to comply with all required protocol visits and complete all assessments.
• Must be willing to complete 2 years of routine clinic follow-ups after study completion as per cladribine tablets FDA guidelines.
• Must have read the FDA approved patient labeling (medication guide) and be counseled, risk of teratogenicity, lactation, lymphopenia and other hematologic toxicity, infections, liver injury, hypersensitivity, cardiac failure and treatment handling and administration.
• If female: must have a negative serum pregnancy test at screen and week 48 and a negative urine pregnancy test at baseline. All females must agree to notify us immediately if they have concern of possible pregnancy.
• If female: be neither pregnant or breastfeeding, nor attempting to conceive AND
• Use a highly effective method of contraception throughout the entire duration of the study and for 6 months (5 menstrual cycles) following completion of the last dose of study medication. As it is currently unknown whether cladribine tablets may reduce the effectiveness of systemically acting hormonal contraceptives, a barrier method of contraception should be implemented for the duration of the study.
• If Male: must be willing to use contraception to avoid contributing to pregnancies 6 months following the last dose of study medication.

You may not qualify if:

• Subjects with a diagnosis of a sub-type of MS other than PMS active (clinically definite SPMS)
• Have MRI findings other than MS that are considered significant per the P.I.
• Have a clinical condition or medical history noted as a contraindication as per the FDA/US package insert guidelines.
• Have a history of chronic disease(s) of the immune system, other than MS or a known immunodeficiency syndrome.
• Have comorbid conditions that preclude participation, including any condition that might increase brain biomarkers such as traumatic brain injury (TBI), meningitis, stroke, or drug abuse in the last 12 months or any other medical condition deemed significant for increased biomarkers by the investigator.
• Have an active/acute infection (bacterial, viral, fungal, etc.) at the time of screen AND/OR baseline or within 4 weeks prior to or at the start of course 2 year 2 that would interfere with the safety of the study.
• Have a current or past significant history of poorly controlled diabetes mellitus, obesity (BMI over 35) or anorexia (BMI under 18), hypertension or hyperlipidemia as determined by the investigator.
• Have a history or presence of malignancy other than basal cell epithelioma (BCE) or cervical cancer in-situ following a complete excision. Cancer that has been absent for more than 10 years and considered to be cured is allowed.
• a. All standard cancer screening guidelines should be followed for subjects that are treated with cladribine tablets during the course of the study.
• Known liver conditions including the following:
• History or current hepatic impairment considered moderate or severe. Subjects with mild hepatic impairment can be considered at the investigator's discretion.
• Current or known history of alcohol abuse
• Chronic liver or biliary diseases
• Total or conjugated bilirubin greater than the upper limit of normal range
• Alkaline phosphatase (AP) greater than 1.5 times the upper limit of the normal range

Sponsors & Collaborators

• Keith Edwards, M.D.: lead
• EMD Serono: collaborator

Study Sites (1)

Multiple Sclerosis Center of Northeastern New York, P.C.

Latham, New York, 12110, United States

RECRUITING

Related Publications (52)

• Baker D, Herrod SS, Alvarez-Gonzalez C, Zalewski L, Albor C, Schmierer K. Both cladribine and alemtuzumab may effect MS via B-cell depletion. Neurol Neuroimmunol Neuroinflamm. 2017 Jun 5;4(4):e360. doi: 10.1212/NXI.0000000000000360. eCollection 2017 Jul.

  PMID: 28626781 BACKGROUND

• Bjornevik K, Munger KL, Cortese M, Barro C, Healy BC, Niebuhr DW, Scher AI, Kuhle J, Ascherio A. Serum Neurofilament Light Chain Levels in Patients With Presymptomatic Multiple Sclerosis. JAMA Neurol. 2020 Jan 1;77(1):58-64. doi: 10.1001/jamaneurol.2019.3238.

  PMID: 31515562 BACKGROUND

• Brureau A, Blanchard-Bregeon V, Pech C, Hamon S, Chaillou P, Guillemot JC, Barneoud P, Bertrand P, Pradier L, Rooney T, Schussler N. NF-L in cerebrospinal fluid and serum is a biomarker of neuronal damage in an inducible mouse model of neurodegeneration. Neurobiol Dis. 2017 Aug;104:73-84. doi: 10.1016/j.nbd.2017.04.007. Epub 2017 Apr 6.

  PMID: 28392472 BACKGROUND

• Comi G, Cook SD, Giovannoni G, Rammohan K, Rieckmann P, Sorensen PS, Vermersch P, Hamlett AC, Viglietta V, Greenberg SJ. MRI outcomes with cladribine tablets for multiple sclerosis in the CLARITY study. J Neurol. 2013 Apr;260(4):1136-46. doi: 10.1007/s00415-012-6775-0. Epub 2012 Dec 21.

  PMID: 23263473 BACKGROUND

• Comi G, Cook S, Rammohan K, Soelberg Sorensen P, Vermersch P, Adeniji AK, Dangond F, Giovannoni G. Long-term effects of cladribine tablets on MRI activity outcomes in patients with relapsing-remitting multiple sclerosis: the CLARITY Extension study. Ther Adv Neurol Disord. 2018 Jan 23;11:1756285617753365. doi: 10.1177/1756285617753365. eCollection 2018.

  PMID: 29399054 BACKGROUND

• Edwards KR, Garten L, Button J, O'Connor J, Kamath V, Frazier C. Neurofilament light chain as an indicator of exacerbation prior to clinical symptoms in multiple sclerosis. Mult Scler Relat Disord. 2019 Jun;31:59-61. doi: 10.1016/j.msard.2019.03.016. Epub 2019 Mar 23.

  PMID: 30927733 BACKGROUND

• Freedman MS, Leist TP, Comi G, Cree BA, Coyle PK, Hartung HP, Vermersch P, Damian D, Dangond F. The efficacy of cladribine tablets in CIS patients retrospectively assigned the diagnosis of MS using modern criteria: Results from the ORACLE-MS study. Mult Scler J Exp Transl Clin. 2017 Oct 9;3(4):2055217317732802. doi: 10.1177/2055217317732802. eCollection 2017 Oct-Dec.

  PMID: 29051829 BACKGROUND

• Feys P, Lamers I, Francis G, Benedict R, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. The Nine-Hole Peg Test as a manual dexterity performance measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):711-720. doi: 10.1177/1352458517690824. Epub 2017 Feb 16.

  PMID: 28206826 BACKGROUND

• Gafson AR, Kim K, Cencioni MT, van Hecke W, Nicholas R, Baranzini SE, Matthews PM. Mononuclear cell transcriptome changes associated with dimethyl fumarate in MS. Neurol Neuroimmunol Neuroinflamm. 2018 Jun 12;5(4):e470. doi: 10.1212/NXI.0000000000000470. eCollection 2018 Jul.

  PMID: 30283812 BACKGROUND

• Giovannoni G, Comi G, Cook S, Rammohan K, Rieckmann P, Soelberg Sorensen P, Vermersch P, Chang P, Hamlett A, Musch B, Greenberg SJ; CLARITY Study Group. A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5):416-26. doi: 10.1056/NEJMoa0902533. Epub 2010 Jan 20.

  PMID: 20089960 BACKGROUND

• Giovannoni G, Cook S, Rammohan K, Rieckmann P, Sorensen PS, Vermersch P, Hamlett A, Viglietta V, Greenberg S; CLARITY study group. Sustained disease-activity-free status in patients with relapsing-remitting multiple sclerosis treated with cladribine tablets in the CLARITY study: a post-hoc and subgroup analysis. Lancet Neurol. 2011 Apr;10(4):329-37. doi: 10.1016/S1474-4422(11)70023-0.

  PMID: 21397565 BACKGROUND

• Giovannoni G, Cutter G, Sormani MP, Belachew S, Hyde R, Koendgen H, Knappertz V, Tomic D, Leppert D, Herndon R, Wheeler-Kingshott CAM, Ciccarelli O, Selwood D, di Cantogno EV, Ben-Amor AF, Matthews P, Carassiti D, Baker D, Schmierer K. Is multiple sclerosis a length-dependent central axonopathy? The case for therapeutic lag and the asynchronous progressive MS hypotheses. Mult Scler Relat Disord. 2017 Feb;12:70-78. doi: 10.1016/j.msard.2017.01.007. Epub 2017 Jan 17.

  PMID: 28283111 BACKGROUND

• Giovannoni G, Soelberg Sorensen P, Cook S, Rammohan KW, Rieckmann P, Comi G, Dangond F, Hicking C, Vermersch P. Efficacy of Cladribine Tablets in high disease activity subgroups of patients with relapsing multiple sclerosis: A post hoc analysis of the CLARITY study. Mult Scler. 2019 May;25(6):819-827. doi: 10.1177/1352458518771875. Epub 2018 May 2.

  PMID: 29716436 BACKGROUND

• Giovannoni G, Soelberg Sorensen P, Cook S, Rammohan K, Rieckmann P, Comi G, Dangond F, Adeniji AK, Vermersch P. Safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis: Results from the randomized extension trial of the CLARITY study. Mult Scler. 2018 Oct;24(12):1594-1604. doi: 10.1177/1352458517727603. Epub 2017 Sep 5.

  PMID: 28870107 BACKGROUND

• Gold R, Giovannoni G, Selmaj K, Havrdova E, Montalban X, Radue EW, Stefoski D, Robinson R, Riester K, Rana J, Elkins J, O'Neill G; SELECT study investigators. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Jun 22;381(9884):2167-75. doi: 10.1016/S0140-6736(12)62190-4. Epub 2013 Apr 4.

  PMID: 23562009 BACKGROUND

• Gregson A, Thompson K, Tsirka SE, Selwood DL. Emerging small-molecule treatments for multiple sclerosis: focus on B cells. F1000Res. 2019 Mar 1;8:F1000 Faculty Rev-245. doi: 10.12688/f1000research.16495.1. eCollection 2019.

  PMID: 30863536 BACKGROUND

• Gunnarsson M, Malmestrom C, Axelsson M, Sundstrom P, Dahle C, Vrethem M, Olsson T, Piehl F, Norgren N, Rosengren L, Svenningsson A, Lycke J. Axonal damage in relapsing multiple sclerosis is markedly reduced by natalizumab. Ann Neurol. 2011 Jan;69(1):83-9. doi: 10.1002/ana.22247. Epub 2010 Dec 8.

  PMID: 21280078 BACKGROUND

• Havrdova E, Galetta S, Hutchinson M, Stefoski D, Bates D, Polman CH, O'Connor PW, Giovannoni G, Phillips JT, Lublin FD, Pace A, Kim R, Hyde R. Effect of natalizumab on clinical and radiological disease activity in multiple sclerosis: a retrospective analysis of the Natalizumab Safety and Efficacy in Relapsing-Remitting Multiple Sclerosis (AFFIRM) study. Lancet Neurol. 2009 Mar;8(3):254-60. doi: 10.1016/S1474-4422(09)70021-3. Epub 2009 Feb 7.

  PMID: 19201654 BACKGROUND

• Havrdova E, Arnold DL, Bar-Or A, Comi G, Hartung HP, Kappos L, Lublin F, Selmaj K, Traboulsee A, Belachew S, Bennett I, Buffels R, Garren H, Han J, Julian L, Napieralski J, Hauser SL, Giovannoni G. No evidence of disease activity (NEDA) analysis by epochs in patients with relapsing multiple sclerosis treated with ocrelizumab vs interferon beta-1a. Mult Scler J Exp Transl Clin. 2018 Mar 12;4(1):2055217318760642. doi: 10.1177/2055217318760642. eCollection 2018 Jan-Mar.

  PMID: 29568544 BACKGROUND

• Hermann R, Karlsson MO, Novakovic AM, Terranova N, Fluck M, Munafo A. The Clinical Pharmacology of Cladribine Tablets for the Treatment of Relapsing Multiple Sclerosis. Clin Pharmacokinet. 2019 Mar;58(3):283-297. doi: 10.1007/s40262-018-0695-9.

  PMID: 29987837 BACKGROUND

• Hogel H, Rissanen E, Barro C, Matilainen M, Nylund M, Kuhle J, Airas L. Serum glial fibrillary acidic protein correlates with multiple sclerosis disease severity. Mult Scler. 2020 Feb;26(2):210-219. doi: 10.1177/1352458518819380. Epub 2018 Dec 20.

  PMID: 30570436 BACKGROUND

• Hutchinson M. The only certain measure of the effectiveness of multiple sclerosis therapy is cerebrospinal neurofilament level: Commentary. Mult Scler. 2015 Sep;21(10):1242-3. doi: 10.1177/1352458515599682. Epub 2015 Aug 4. No abstract available.

  PMID: 26242693 BACKGROUND

• Kingwell E, Marriott JJ, Jette N, Pringsheim T, Makhani N, Morrow SA, Fisk JD, Evans C, Beland SG, Kulaga S, Dykeman J, Wolfson C, Koch MW, Marrie RA. Incidence and prevalence of multiple sclerosis in Europe: a systematic review. BMC Neurol. 2013 Sep 26;13:128. doi: 10.1186/1471-2377-13-128.

  PMID: 24070256 BACKGROUND

• Kuhle J, Plavina T, Barro C, Disanto G, Sangurdekar D, Singh CM, de Moor C, Engle B, Kieseier BC, Fisher E, Kappos L, Rudick RA, Goyal J. Neurofilament light levels are associated with long-term outcomes in multiple sclerosis. Mult Scler. 2020 Nov;26(13):1691-1699. doi: 10.1177/1352458519885613. Epub 2019 Nov 4.

  PMID: 31680621 BACKGROUND

• Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.

  PMID: 6685237 BACKGROUND

• Leist TP, Comi G, Cree BA, Coyle PK, Freedman MS, Hartung HP, Vermersch P, Casset-Semanaz F, Scaramozza M; oral cladribine for early MS (ORACLE MS) Study Group. Effect of oral cladribine on time to conversion to clinically definite multiple sclerosis in patients with a first demyelinating event (ORACLE MS): a phase 3 randomised trial. Lancet Neurol. 2014 Mar;13(3):257-67. doi: 10.1016/S1474-4422(14)70005-5. Epub 2014 Feb 4.

  PMID: 24502830 BACKGROUND

• Leppert D, Kuhle J. Serum NfL levels should be used to monitor multiple sclerosis evolution - Yes. Mult Scler. 2020 Jan;26(1):17-19. doi: 10.1177/1352458519872921. Epub 2019 Oct 18. No abstract available.

  PMID: 31625807 BACKGROUND

• Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stuve O, Waubant E, Polman CH. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28.

  PMID: 24871874 BACKGROUND

• Marrie RA, Goldman M. Validity of performance scales for disability assessment in multiple sclerosis. Mult Scler. 2007 Nov;13(9):1176-82. doi: 10.1177/1352458507078388. Epub 2007 Jul 10.

  PMID: 17623733 BACKGROUND

• Noseworthy JH, Lucchinetti C, Rodriguez M, Weinshenker BG. Multiple sclerosis. N Engl J Med. 2000 Sep 28;343(13):938-52. doi: 10.1056/NEJM200009283431307. No abstract available.

  PMID: 11006371 BACKGROUND

• Okai AF, Amezcua L, Berkovich RR, Chinea AR, Edwards KR, Steingo B, Walker A, Jacobs AK, Daizadeh N, Williams MJ; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurol Ther. 2019 Dec;8(2):367-381. doi: 10.1007/s40120-019-00159-2. Epub 2019 Oct 25.

  PMID: 31654272 BACKGROUND

• Pardo G, Jones DE. The sequence of disease-modifying therapies in relapsing multiple sclerosis: safety and immunologic considerations. J Neurol. 2017 Dec;264(12):2351-2374. doi: 10.1007/s00415-017-8594-9. Epub 2017 Sep 6.

  PMID: 28879412 BACKGROUND

• Polman CH, O'Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW; AFFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):899-910. doi: 10.1056/NEJMoa044397.

  PMID: 16510744 BACKGROUND

• Przybek J, Gniatkowska I, Mirowska-Guzel D, Czlonkowska A. Evolution of diagnostic criteria for multiple sclerosis. Neurol Neurochir Pol. 2015;49(5):313-21. doi: 10.1016/j.pjnns.2015.07.006. Epub 2015 Aug 5.

  PMID: 26377983 BACKGROUND

• Puentes F, van der Star BJ, Boomkamp SD, Kipp M, Boon L, Bosca I, Raffel J, Gnanapavan S, van der Valk P, Stephenson J, Barnett SC, Baker D, Amor S. Neurofilament light as an immune target for pathogenic antibodies. Immunology. 2017 Dec;152(4):580-588. doi: 10.1111/imm.12797. Epub 2017 Aug 11.

  PMID: 28718500 BACKGROUND

• Rochwerg B, Almenawer SA, Siemieniuk RAC, Vandvik PO, Agoritsas T, Lytvyn L, Alhazzani W, Archambault P, D'Aragon F, Farhoumand PD, Guyatt G, Laake JH, Beltran-Arroyave C, McCredie V, Price A, Chabot C, Zervakis T, Badhiwala J, St-Onge M, Szczeklik W, Moller MH, Lamontagne F. Atraumatic (pencil-point) versus conventional needles for lumbar puncture: a clinical practice guideline. BMJ. 2018 May 22;361:k1920. doi: 10.1136/bmj.k1920. No abstract available.

  PMID: 29789372 BACKGROUND

• Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW; SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):911-23. doi: 10.1056/NEJMoa044396.

  PMID: 16510745 BACKGROUND

• SCHUMACHER GA, BEEBE G, KIBLER RF, KURLAND LT, KURTZKE JF, MCDOWELL F, NAGLER B, SIBLEY WA, TOURTELLOTTE WW, WILLMON TL. PROBLEMS OF EXPERIMENTAL TRIALS OF THERAPY IN MULTIPLE SCLEROSIS: REPORT BY THE PANEL ON THE EVALUATION OF EXPERIMENTAL TRIALS OF THERAPY IN MULTIPLE SCLEROSIS. Ann N Y Acad Sci. 1965 Mar 31;122:552-68. doi: 10.1111/j.1749-6632.1965.tb20235.x. No abstract available.

  PMID: 14313512 BACKGROUND

• Schwartz CE, Powell VE. The Performance Scales disability measure for multiple sclerosis: use and sensitivity to clinically important differences. Health Qual Life Outcomes. 2017 Mar 9;15(1):47. doi: 10.1186/s12955-017-0614-z.

  PMID: 28274258 BACKGROUND

• Stankiewicz JM, Weiner HL. An argument for broad use of high efficacy treatments in early multiple sclerosis. Neurol Neuroimmunol Neuroinflamm. 2019 Nov 22;7(1):e636. doi: 10.1212/NXI.0000000000000636. Print 2020 Jan.

  PMID: 31757815 BACKGROUND

• Strober L, DeLuca J, Benedict RH, Jacobs A, Cohen JA, Chiaravalloti N, Hudson LD, Rudick RA, LaRocca NG; Multiple Sclerosis Outcome Assessments Consortium (MSOAC). Symbol Digit Modalities Test: A valid clinical trial endpoint for measuring cognition in multiple sclerosis. Mult Scler. 2019 Nov;25(13):1781-1790. doi: 10.1177/1352458518808204. Epub 2018 Oct 18.

  PMID: 30334474 BACKGROUND

• Scalfari A, Knappertz V, Cutter G, Goodin DS, Ashton R, Ebers GC. Mortality in patients with multiple sclerosis. Neurology. 2013 Jul 9;81(2):184-92. doi: 10.1212/WNL.0b013e31829a3388.

  PMID: 23836941 BACKGROUND

• Trapp BD, Peterson J, Ransohoff RM, Rudick R, Mork S, Bo L. Axonal transection in the lesions of multiple sclerosis. N Engl J Med. 1998 Jan 29;338(5):278-85. doi: 10.1056/NEJM199801293380502.

  PMID: 9445407 BACKGROUND

• Montalban X, Gold R, Thompson AJ, Otero-Romero S, Amato MP, Chandraratna D, Clanet M, Comi G, Derfuss T, Fazekas F, Hartung HP, Havrdova E, Hemmer B, Kappos L, Liblau R, Lubetzki C, Marcus E, Miller DH, Olsson T, Pilling S, Selmaj K, Siva A, Sorensen PS, Sormani MP, Thalheim C, Wiendl H, Zipp F. ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis. Mult Scler. 2018 Feb;24(2):96-120. doi: 10.1177/1352458517751049. Epub 2018 Jan 20.

  PMID: 29353550 BACKGROUND

• Nielsen AS, Kinkel RP, Madigan N, Tinelli E, Benner T, Mainero C. Contribution of cortical lesion subtypes at 7T MRI to physical and cognitive performance in MS. Neurology. 2013 Aug 13;81(7):641-9. doi: 10.1212/WNL.0b013e3182a08ce8. Epub 2013 Jul 17.

  PMID: 23864311 BACKGROUND

• Kollia K, Maderwald S, Putzki N, Schlamann M, Theysohn JM, Kraff O, Ladd ME, Forsting M, Wanke I. First clinical study on ultra-high-field MR imaging in patients with multiple sclerosis: comparison of 1.5T and 7T. AJNR Am J Neuroradiol. 2009 Apr;30(4):699-702. doi: 10.3174/ajnr.A1434. Epub 2009 Jan 15.

  PMID: 19147714 BACKGROUND

• Pitt D, Boster A, Pei W, Wohleb E, Jasne A, Zachariah CR, Rammohan K, Knopp MV, Schmalbrock P. Imaging cortical lesions in multiple sclerosis with ultra-high-field magnetic resonance imaging. Arch Neurol. 2010 Jul;67(7):812-8. doi: 10.1001/archneurol.2010.148.

  PMID: 20625086 BACKGROUND

• Kister I, Bacon TE, Chamot E, Salter AR, Cutter GR, Kalina JT, Herbert J. Natural history of multiple sclerosis symptoms. Int J MS Care. 2013 Fall;15(3):146-58. doi: 10.7224/1537-2073.2012-053.

  PMID: 24453777 BACKGROUND

• Salter A, Thomas N, Tyry T, Cutter G, Marrie RA. Employment and absenteeism in working-age persons with multiple sclerosis. J Med Econ. 2017 May;20(5):493-502. doi: 10.1080/13696998.2016.1277229. Epub 2017 Jan 25.

  PMID: 28035846 BACKGROUND

• Correale J, Gaitan MI, Ysrraelit MC, Fiol MP. Progressive multiple sclerosis: from pathogenic mechanisms to treatment. Brain. 2017 Mar 1;140(3):527-546. doi: 10.1093/brain/aww258.

  PMID: 27794524 BACKGROUND

• Confavreux C, Vukusic S, Moreau T, Adeleine P. Relapses and progression of disability in multiple sclerosis. N Engl J Med. 2000 Nov 16;343(20):1430-8. doi: 10.1056/NEJM200011163432001.

  PMID: 11078767 BACKGROUND

• Jack D, Nolting A, Galazka A. Favorable outcomes after COVID-19 infection in multiple sclerosis patients treated with cladribine tablets. Mult Scler Relat Disord. 2020 Nov;46:102469. doi: 10.1016/j.msard.2020.102469. Epub 2020 Aug 27. No abstract available.

  PMID: 32919180 BACKGROUND

Related Links

• Protocol Reference # 7
• Protocol Reference # 9
• Protocol Reference #12
• Protocol Reference # 14
• Protocol Reference # 22
• Protocol Reference #55
• Protocol Reference # 61

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cladribine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Keith R Edwards, M.D.

  MS Center of Northeastern New York, P.C.

  STUDY DIRECTOR

Central Study Contacts

Judy Button

CONTACT

518-785-1000; jbutton@tristateneuro.com

Vineetha Kamath

CONTACT

518-785-1000; vkamath@tristateneuro.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: Boxes for treatment cycles distributed will be based on weight

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 16, 2020
• Study Start: September 16, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)