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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00641537
Registration number
NCT00641537
Ethics application status
Date submitted
13/03/2008
Date registered
24/03/2008
Date last updated
7/12/2020
Titles & IDs
Public title
CLARITY Extension Study
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Scientific title
A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects With Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY)
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Secondary ID [1]
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2007-000381-20
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Secondary ID [2]
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27820
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cladribine
Treatment: Drugs - Placebo
Treatment: Drugs - Cladribine
Treatment: Drugs - Cladribine
Treatment: Drugs - Placebo
Placebo comparator: Cladribine Low/Placebo (LLPP) -
Placebo comparator: Cladribine High Dose/Placebo (HLPP) -
Experimental: Cladribine Low/Low Dose (LLLL) -
Experimental: Cladribine High/Low Dose (HLLL) -
Experimental: Placebo/Cladribine Low Dose (PPLL) -
No intervention: Placebo/No Treatment -
No intervention: 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 intervention: 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).
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety Population: Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 4 Hematologic and Hepatic Toxicity
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Assessment method [1]
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Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events v 3.0 (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. According to CTCAE v3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death.
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Timepoint [1]
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Baseline up to Week 120
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Primary outcome [2]
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Safety Population: Mean Change From Baseline in Absolute Lymphocyte Count, Platelet, Neutrophils and Leukocytes at Week 120
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Assessment method [2]
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Mean change from baseline in absolute lymphocyte count, platelet, neutrophils and leukocytes at week 120 were reported.
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Timepoint [2]
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Baseline, Week 120
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Primary outcome [3]
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Safety Population: Mean Change From Baseline in Hemoglobin at Week 120
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Assessment method [3]
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Mean change from baseline in hemoglobin at Week 120 was reported.
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Timepoint [3]
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Baseline, Week 120
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Primary outcome [4]
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Safety Population: Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase at Week 120
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Assessment method [4]
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Mean change from baseline in aspartate aminotransferase and alanine aminotransferase at week 120 were reported.
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Timepoint [4]
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Baseline, Week 120
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Primary outcome [5]
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Safety Population: Mean Change From Baseline in Bilirubin at Week 120
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Assessment method [5]
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Mean Change From Baseline in Bilirubin at week 120 was reported.
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Timepoint [5]
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Baseline, Week 120
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Primary outcome [6]
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Safety Population: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
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Assessment method [6]
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An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. Serious AE (SAE): Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. Number of participants with TEAEs included participants with both non-serious TEAEs and serious TEAEs.
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Timepoint [6]
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Baseline up to Week 120
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Primary outcome [7]
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SAFUP Analysis Set: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
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Assessment method [7]
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An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. Number of participants with TEAEs included participants with both non-serious TEAEs and serious TEAEs.
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Timepoint [7]
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Baseline up to Week 120
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Primary outcome [8]
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Safety Population: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies
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Assessment method [8]
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Number of participants who developed Herpes viral infection, Viral infectious disorder and Opportunistic infection are reported. Number of participants with infection related adverse events are the number of participants who had at least one adverse event coded to medical dictionary for regulatory activities (MedDRA) preferred terms under infection and infestation system organ class. Malignancy is defined as having at least one adverse event coded to MedDRA preferred terms under the pre-specified grouping Malignant and unspecified tumors.
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Timepoint [8]
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Baseline up to Week 120
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Primary outcome [9]
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SAFUP Analysis Set: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies
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Assessment method [9]
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Number of participants who developed Herpes viral infection, Viral infectious disorder and Opportunistic infection were reported. Number of participants with infection related adverse events are the number of participants who had at least one adverse event coded to medical dictionary for regulatory activities (MedDRA) preferred terms under infection and infestation system organ class. Malignancy is defined as having at least one adverse event coded to MedDRA preferred terms under the pre-specified grouping Malignant and unspecified tumors.
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Timepoint [9]
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Baseline up to Week 120
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Primary outcome [10]
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Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity
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Assessment method [10]
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Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. Time to first CTCAE Grade 3 or 4 hematological or liver toxicity was analyzed by treatment group using Kaplan-Meier plots of probability of surviving toxicity-free and point estimates of percentiles. According to CTCAE version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. 10th, 20th, 25th, 50th and 75th percentiles were estimated from Kaplan-Meier survival curve.
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Timepoint [10]
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Baseline up to Week 120
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Primary outcome [11]
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Safety Population: Median Time to Recovery From Grade 3 or 4 Hematological and Hepatic Toxicity
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Assessment method [11]
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Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. According to CTCAE version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. Time to recovery from grade 3 or 4 hematological or liver toxicity were reported: lymphocytes, platelets, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT), Aspartate transaminase (AST), Platelets and Bilirubin. Recovery from a Grade 3 or 4 toxicity is defined as a return to a Grade 0 or 1.
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Timepoint [11]
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Baseline up to Week 120
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Primary outcome [12]
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Safety Population: Mean Time to Recovery From Grade 3 or 4 Hematological and Liver Toxicity
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Assessment method [12]
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Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. According to CTCAE v3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. Time to recovery from grade 3 or 4 hematological or liver toxicity were reported: lymphocytes, platelets, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT), Aspartate transaminase (AST) and Platelets. Recovery from a Grade 3 or 4 toxicity is defined as a return to a Grade 0 or 1.
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Timepoint [12]
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Baseline up to Week 120
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Primary outcome [13]
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Safety Population: Median Time to Nadir of Absolute Lymphocyte Count
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Assessment method [13]
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Median time to nadir of absolute lymphocyte count was reported.
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Timepoint [13]
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Baseline up to Week 120
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Primary outcome [14]
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Safety Population: Mean Time to Nadir of Absolute Lymphocyte Count
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Assessment method [14]
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Mean time to nadir of absolute lymphocyte count was reported.
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Timepoint [14]
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Baseline up to Week 120
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Primary outcome [15]
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Safety Population: Mean Time to Recovery From Nadir of Absolute Lymphocyte Count to Normal Value
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Assessment method [15]
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Mean time to recovery from nadir of absolute lymphocyte count to normal was reported. Recovery from Nadir is defined as a return to baseline value. Normal absolute lymphocyte count is 1.02 x 10\^3 cells/microliter.
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Timepoint [15]
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Baseline up to Week 120
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Primary outcome [16]
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Safety Population: Mean Change in Corrected QT (QTc) Interval From Baseline
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Assessment method [16]
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The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Mean change in corrected QT (QTc) interval from baseline was reported.
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Timepoint [16]
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Baseline, Week 5, 48, 52 and 96
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Eligibility
Key inclusion criteria
* Randomized in Trial 25643 and satisfied one of the following:
* 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
* Other protocol-defined inclusion/exclusion criteria may apply
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Participants who were not enrolled in Trial 25643
* 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/02/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/12/2011
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Sample size
Target
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Accrual to date
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Final
867
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Camperdown
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Recruitment hospital [2]
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Research Site - Melbourne
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Recruitment hospital [3]
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Research Site - Victoria
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Recruitment postcode(s) [1]
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- Camperdown
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Recruitment postcode(s) [2]
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- Melbourne
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Recruitment postcode(s) [3]
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- Victoria
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Recruitment outside Australia
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United States of America
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State/province [1]
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Colorado
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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Nevada
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United States of America
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New Jersey
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United States of America
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North Carolina
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Ohio
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United States of America
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Oklahoma
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United States of America
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Oregon
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United States of America
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Washington
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United States of America
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West Virginia
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Austria
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Linz
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Belgium
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Diepenbeek
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Belgium
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Esneux
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Brazil
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Recife
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Shuman
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Bulgaria
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Zagora
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Canada
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Burnaby
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Canada
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Greenfield Park
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Canada
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Ottawa
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Canada
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Quebec
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Croatia
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Karlovac
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Croatia
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Sisak
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Croatia
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Split
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Czechia
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Hradec Králové
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Czechia
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Olomouc
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Czechia
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Praha
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Denmark
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Copenhagen
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Estonia
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Tallinn
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Estonia
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Tartu
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Finland
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Oulu
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Finland
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Turku
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France
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Clermont-Ferrand
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France
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Lille
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France
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Nancy
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France
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Nimes
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France
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Paris
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France
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Rennes
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France
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Saint Herblain
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Germany
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Bochum
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Germany
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Frankfurt
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Germany
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Giessen
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Germany
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Hannover
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Germany
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Regensburg
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Germany
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Rostock
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Greece
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Athens
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Italy
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Bari
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0
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Italy
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Cagliari
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0
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Italy
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0
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Catania
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0
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Italy
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State/province [57]
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Firenze
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0
0
Italy
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State/province [58]
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Genova
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0
0
Italy
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Milano
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0
0
Italy
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State/province [60]
0
0
Napoli
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0
0
Italy
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State/province [61]
0
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Padova
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Country [62]
0
0
Italy
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0
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Roma
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Country [63]
0
0
Latvia
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State/province [63]
0
0
Riga
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Beyrouth
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Fes
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Kemerovo
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Russian Federation
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Moscow
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Tomsk
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Vladimir
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Riyadh
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Lausanne
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Tunis
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Izmir
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Ukraine
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Kharkov
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Ukraine
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Kiev
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Ukraine
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Lviv
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Ukraine
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Vinnitsa
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United Kingdom
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Hull
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United Kingdom
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London
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United Kingdom
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Nottingham
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Oxford
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United Kingdom
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Sheffield
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United Kingdom
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Stoke-on-Trent
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Funding & Sponsors
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Name
EMD Serono Research & Development Institute, Inc.
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Summary
Brief summary
The purpose of this extension trial was to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within Trial 25643 (CLARITY). This trial also explored clinical benefit of prolonged 192-week versus 96-week treatment.
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Trial website
https://clinicaltrials.gov/study/NCT00641537
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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Medical Responsible
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00641537
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