Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
867 participants
INTERVENTIONAL
2008-02-29
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cladribine Low/Placebo (LLPP)
Placebo
Participants who received Cladribine 3.5 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive placebo matched to cladribine tablet 0.875 mg/kg orally administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 during the treatment period of 96 weeks.
Cladribine High Dose/Placebo (HLPP)
Placebo
Participants who received Cladribine 5.25 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive placebo matched to cladribine tablet 0.875 mg/kg orally administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 during the treatment period of 96 weeks.
Cladribine Low/Low Dose (LLLL)
Cladribine
Participants who received Cladribine 3.5 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
Cladribine High/Low Dose (HLLL)
Cladribine
Participants who received Cladribine 5.25 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
Placebo/Cladribine Low Dose (PPLL)
Cladribine
Participants who received placebo in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
Placebo/No Treatment
No interventions assigned to this group
Cladribine 3.5 mg/kg/No Treatment
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
No interventions assigned to this group
Cladribine 5.25 mg/kg/No Treatment
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
No interventions assigned to this group
Interventions
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Cladribine
Participants who received Cladribine 3.5 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
Placebo
Participants who received Cladribine 3.5 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive placebo matched to cladribine tablet 0.875 mg/kg orally administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 during the treatment period of 96 weeks.
Cladribine
Participants who received Cladribine 5.25 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
Cladribine
Participants who received placebo in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
Placebo
Participants who received Cladribine 5.25 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive placebo matched to cladribine tablet 0.875 mg/kg orally administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 during the treatment period of 96 weeks.
Eligibility Criteria
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Inclusion Criteria
* Completed randomized treatment course and scheduled visits for the full 96 weeks; or
* Did not complete the randomized treatment course in Trial 25643 but elected to receive rescue treatment with Rebif®, another beta-interferon, or glatiramer acetate and completed scheduled clinic visits for the full 96 weeks; or
* Did not complete the randomized treatment course in Trial 25643, declined rescue with Rebif®, another beta-interferon, or glatiramer acetate and still completed scheduled clinic visits for the full 96 weeks; or
* Did not complete the randomized treatment course in Trial 25643, were not eligible for rescue option with Rebif®, and still completed scheduled clinic visits for the full 96 weeks
* Male or female, between 18 and 65 years of age (inclusive, at time of informed consent for Trial 25643)
* No medical history or evidence of latent tuberculosis infection (LTBI) or tuberculosis (TB), as evidenced by TB skin test or chest X-ray
* All of the following laboratory hematologic parameters evaluated as normal (as define below, inclusively) within 28 days of first dosing of blinded study medication at study Day 1:
* Hemoglobin = 11.6 to 16.2 gram per deciliter (g/dL)
* Leukocytes (total white blood cell) = 4.1 to 12.3\*10\^3 per microliter
* Absolute lymphocyte count (ALC) = 1.02 to 3.36\*10\^3 per microliter
* Absolute neutrophil count (ANC) = 2.03 to 8.36\*10\^3 per microliter
* Platelet count = 140 to 450\*10\^3 per microliter
Exclusion Criteria
* Participant has moderate to severe renal impairment
* Use of mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab at any time during and since Trial 25643
* Use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (IVIG) or plasmapheresis at any time during and since Trial 25643
* Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days before Study Day 1
18 Years
65 Years
ALL
No
Sponsors
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EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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Research Site
Boulder, Colorado, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
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Northbrook, Illinois, United States
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Baltimore, Maryland, United States
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Ann Arbor, Michigan, United States
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Henderson, Nevada, United States
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Newark, New Jersey, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Medford, Oregon, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Charleston, West Virginia, United States
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Camperdown, , Australia
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Melbourne, , Australia
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Victoria, , Australia
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Linz, , Austria
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Diepenbeek, , Belgium
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Esneux, , Belgium
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Recife, , Brazil
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Shuman, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Zagora, , Bulgaria
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Burnaby, , Canada
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Greenfield Park, , Canada
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Ottawa, , Canada
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Québec, , Canada
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Karlovac, , Croatia
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Sisak, , Croatia
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Split, , Croatia
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Copenhagen, , Denmark
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Tallinn, , Estonia
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Tartu, , Estonia
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Oulu, , Finland
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Turku, , Finland
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Clermont-Ferrand, , France
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Lille, , France
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Nancy, , France
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Nîmes, , France
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Paris, , France
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Rennes, , France
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Saint-Herblain, , France
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Bochum, , Germany
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Frankfurt, , Germany
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Giessen, , Germany
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Hanover, , Germany
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Regensburg, , Germany
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Rostock, , Germany
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Athens, , Greece
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Bari, , Italy
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Cagliari, , Italy
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Catania, , Italy
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Florence, , Italy
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Genova, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Roma, , Italy
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Riga, , Latvia
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Beirut, , Lebanon
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Kaunas, , Lithuania
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Casablanca, , Morocco
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Fes, , Morocco
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Rabat, , Morocco
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Sittard- Geleen, , Netherlands
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Gdansk, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Warszawy, , Poland
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Lisbon, , Portugal
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Kaluga, , Russia
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Kazan', , Russia
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Kemerovo, , Russia
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Kursk, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
Research Site
Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
Research Site
Samara, , Russia
Reseach Site
Saratov, , Russia
Research Site
Tomsk, , Russia
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Vladimir, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
Research Site
Riyadh, , Saudi Arabia
Research Site
Belgrade, , Serbia
Research Site
Lausanne, , Switzerland
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Sankt Gallen, , Switzerland
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Monastir, , Tunisia
Research Site
Sfax, , Tunisia
Research Site
Tunis, , Tunisia
Research Site
Bursa, , Turkey (Türkiye)
Research Site
Izmir, , Turkey (Türkiye)
Research Site
Kharkiv, , Ukraine
Research Site
Kiev, , Ukraine
Research Site
Lviv, , Ukraine
Research Site
Vinnitsa, , Ukraine
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Hull, , United Kingdom
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London, , United Kingdom
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Nottingham, , United Kingdom
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Oxford, , United Kingdom
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Sheffield, , United Kingdom
Research Site
Stoke-on-Trent, , United Kingdom
Countries
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References
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Stefano N, Sormani MP, Giovannoni G, Rammohan K, Leist TP, Coyle PK, Dangond F, Alexandri N, Galazka A. Relapses in people with multiple sclerosis treated with cladribine tablets followed for up to 5 years: a plain language summary. Neurodegener Dis Manag. 2022 Dec;12(6):303-310. doi: 10.2217/nmt-2022-0019. Epub 2022 Aug 26.
Giovannoni G, Comi G, Rammohan K, Rieckmann P, Dangond F, Jack D, Vermersch P. Disease stability over five years in people with multiple sclerosis treated with cladribine tablets: a plain language summary. Neurodegener Dis Manag. 2022 Dec;12(6):295-301. doi: 10.2217/nmt-2022-0018. Epub 2022 Aug 26.
Giovannoni G, Coyle PK, Vermersch P, Walker B, Aldridge J, Nolting A, Galazka A, Lemieux C, Leist TP. Integrated Lymphopenia Analysis in Younger and Older Patients With Multiple Sclerosis Treated With Cladribine Tablets. Front Immunol. 2021 Dec 24;12:763433. doi: 10.3389/fimmu.2021.763433. eCollection 2021.
Giovannoni G, Comi G, Rammohan K, Rieckmann P, Dangond F, Keller B, Jack D, Vermersch P. Long-Term Disease Stability Assessed by the Expanded Disability Status Scale in Patients Treated with Cladribine Tablets 3.5 mg/kg for Relapsing Multiple Sclerosis: An Exploratory Post Hoc Analysis of the CLARITY and CLARITY Extension Studies. Adv Ther. 2021 Sep;38(9):4975-4985. doi: 10.1007/s12325-021-01865-w. Epub 2021 Aug 9.
De Stefano N, Sormani MP, Giovannoni G, Rammohan K, Leist T, Coyle PK, Dangond F, Keller B, Alexandri N, Galazka A. Analysis of frequency and severity of relapses in multiple sclerosis patients treated with cladribine tablets or placebo: The CLARITY and CLARITY Extension studies. Mult Scler. 2022 Jan;28(1):111-120. doi: 10.1177/13524585211010294. Epub 2021 May 10.
Giovannoni G, Galazka A, Schick R, Leist T, Comi G, Montalban X, Damian D, Dangond F, Cook S. Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety. Drug Saf. 2020 Jul;43(7):635-643. doi: 10.1007/s40264-020-00948-x.
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.
Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
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2007-000381-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
27820
Identifier Type: -
Identifier Source: org_study_id