|
Welcome
|
|
23 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
|
| [ ...Back to search results ] | [ Print-friendly version ] |
| Clarity Extension Study |
| Link to the ClinicalTrials.gov record | Information obtained from ClinicalTrials.gov on February 14, 2012 |
| Title of trial/grant title | Clarity Extension Study |
| Current status of trial | Active, not recruiting |
| Sponsors and collaborators | EMD Serono |
| Information provided by | EMD Serono |
| ClinicalTrials.gov identifier | NCT00641537 |
| Purpose | The purpose of this extension trial is to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within trial Protocol 25643. |
| Condition(s) | Relapsing-Remitting Multiple Sclerosis |
| Intervention(s) | Drug: Oral Cladribine Drug: Oral Cladribine |
| Phase | Phase III |
| Study type and design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Official title | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, ExtensionTrial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects With Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY) |
| Primary outcome | Safety evaluations include clinical laboratory testing, ECGs and review of adverse events. Safety will be evaluated at every visit. No |
| Secondary outcome | Efficacy will be evaluated on an annual basis and cumulatively over the duration of the 4 year study. Subjects will be evaluated with neurological exam for progression of disease and time to disability as well burden of disease as demonstrated on MRI. Neurological assessments will be performed at various timepoints No |
| Study start | February 2008 |
| Minimum age | 18 Years |
| Maximum age | 65 Years |
| Gender | Both |
| Eligibility criteria | Inclusion Criteria: - Diagnosed with Relapsing-Remitting Multiple Sclerosis - Randomized in Trial 25643 - Be male or female and between 18 and 65 years of age (inclusive, at time of informed consent prior to entry into Trial 25643) - Must weigh between 40-120 kg, inclusive Exclusion Criteria: - Subjects who were not enrolled in Oral Cladribine Protocol # 25643 - Subject has moderate to severe renal impairment - Use of mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab since their completion of Trial 25643 - Use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (IVIG) or plasmapheresis since their completion of Trial 25643 - Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days before Study Day 1 |
| Locations | Colorado, United States Research Site Boulder Colorado Georgia, United States Research Site Atlanta Georgia Illinois, United States Research Site Chicago Illinois Illinois, United States Research Site Northbrook Illinois Maryland, United States Research Site Baltimore Maryland Michigan, United States Research Site Ann Arbor Michigan Nevada, United States Research Site Henderson Nevada New Jersey, United States Research Site Newark New Jersey North Carolina, United States Research Site Charlotte North Carolina North Carolina, United States Research Site Durham North Carolina Ohio, United States Research Site Columbus Ohio Oklahoma, United States Research Site Oklahoma City Oklahoma Oklahoma, United States Research Site Tulsa Oklahoma Oregon, United States Research Site Medford Oregon Washington, United States Research Site Seattle Washington Washington, United States Research Site Tacoma Washington West Virginia, United States Research Site Charleston West Virginia Australia Research Site Camperdown Australia Research Site Melbourne Australia Research Site Victoria Austria Research Site Linz Belgium Research Site Diepenbeek Belgium Research Site Esneux Brazil Research Site Recife Bulgaria Research Site Pleven Bulgaria Research Site Plovdiv Bulgaria Research Site Ruse Bulgaria Research Site Shuman Bulgaria Research Site Sofia Bulgaria Research Site Varna Bulgaria Research Site Zagora Canada Research Site Burnaby Canada Research Site Greenfield Park Canada Research Site Ottawa Canada Research Site Quebec Croatia Research Site Karlovac Croatia Research Site Sisak Croatia Research Site Split Czech Republic Research Site Hradec Králové Czech Republic Research Site Olomouc Czech Republic Research Site Praha Denmark Research Site Copenhagen Estonia Research Site Tallinn Estonia Research Site Tartu Finland Research Site Oulu Finland Research Site Turku France Research Site Clermont-Ferrand France Research Site Lille France Research Site Nancy France Research Site Nimes France Research Site Paris France Research Site Rennes France Research Site Saint Herblain Germany Research Site Bochum Germany Research Site Frankfurt Germany Research Site Giessen Germany Research Site Hannover Germany Research Site Regensburg Germany Research Site Rostock Greece Research Site Athens Italy Research Site Bari Italy Research Site Cagliari Italy Research Site Catania Italy Research Site Firenze Italy Research Site Genova Italy Research Site Milano Italy Research Site Napoli Italy Research Site Padova Italy Research Site Roma Latvia Research Site Riga Lebanon Research Site Beirut Lebanon Research Site Beyrouth Lithuania Research Site Kaunas Morocco Research Site Casablanca Morocco Research Site Fes Morocco Research Site Rabat Netherlands Research Site Sittard- Geleen Poland Research Site Gdansk Poland Research Site Krakow Poland Research Site Lodz Poland Research Site Poznan Poland Research Site Warszawy Portugal Research Site Lisboa Russian Federation Research Site Ekaterinburg Russian Federation Research Site Kaluga Russian Federation Research Site Kazan Russian Federation Research Site Kemerovo Russian Federation Research Site Kursk Russian Federation Research Site Moscow Russian Federation Research Site Nizhny Novgorod Russian Federation Research Site Novosibirsk Russian Federation Research Site Rostov-on-Don Russian Federation Research Site Samara Russian Federation Reseach Site Saratov Russian Federation Research Site St-Petersburg Russian Federation Research Site Tomsk Russian Federation Research Site Vladimir Russian Federation Research Site Yaroslavl Saudi Arabia Research Site Riyadh Serbia Research Site Belgrade Switzerland Research Site Lausanne Switzerland Research Site St. Gallen Tunisia Research Site Monastir Tunisia Research Site Sfax Tunisia Research Site Tunis Turkey Research Site Bursa Turkey Research Site Izmir Ukraine Research Site Kharkov Ukraine Research Site Kiev Ukraine Research Site Lviv Ukraine Research Site Vinnitsa United Kingdom Research Site Hull United Kingdom Research Site London United Kingdom Research Site Nottingham United Kingdom Research Site Oxford United Kingdom Research Site Sheffield United Kingdom Research Site Stoke-on-Trent |
| Study ID numbers | 27820 |
| Last updated | January 23, 2012 |
| Record first received | March 13, 2008 |
| ClinicalTrials.gov identifier | NCT00641537 |
| Download date | Information obtained from ClinicalTrials.gov on February 14, 2012 |
|
|
|
|
|
| © 2012 Current Controlled Trials Ltd. Part of Springer Science+Business Media. | terms & conditions | privacy statement | |
|
|
|
|