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CLARITY Extension Study

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Cladribine

Placebo

Cladribine

Placebo

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Placebo Comparator

Experimental

No Intervention

Arm Label

Cladribine Low/Placebo (LLPP)

Cladribine High Dose/Placebo (HLPP)

Cladribine Low/Low Dose (LLLL)

Cladribine High/Low Dose (HLLL)

Placebo/Cladribine Low Dose (PPLL)

Placebo/No Treatment

Cladribine 3.5 mg/kg/No Treatment

Cladribine 5.25 mg/kg/No Treatment

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

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.

Safety Population: Mean Change From Baseline in Absolute Lymphocyte Count, Platelet, Neutrophils and Leukocytes at Week 120

Mean change from baseline in absolute lymphocyte count, platelet, neutrophils and leukocytes at week 120 were reported.

Safety Population: Mean Change From Baseline in Hemoglobin at Week 120

Mean change from baseline in hemoglobin at Week 120 was reported.

Safety Population: Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase at Week 120

Mean change from baseline in aspartate aminotransferase and alanine aminotransferase at week 120 were reported.

Safety Population: Mean Change From Baseline in Bilirubin at Week 120

Mean Change From Baseline in Bilirubin at week 120 was reported.

Safety Population: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

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.

SAFUP Analysis Set: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

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.

Safety Population: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies

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.

SAFUP Analysis Set: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies

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.

Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity

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.

Safety Population: Median Time to Recovery From Grade 3 or 4 Hematological and Hepatic Toxicity

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.

Safety Population: Mean Time to Recovery From Grade 3 or 4 Hematological and Liver Toxicity

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.

Safety Population: Median Time to Nadir of Absolute Lymphocyte Count

Median time to nadir of absolute lymphocyte count was reported.

Safety Population: Mean Time to Nadir of Absolute Lymphocyte Count

Mean time to nadir of absolute lymphocyte count was reported.

Safety Population: Mean Time to Recovery From Nadir of Absolute Lymphocyte Count to Normal Value

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.

Safety Population: Mean Change in Corrected QT (QTc) Interval From Baseline

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00641537

First Posted

March 13, 2008

Last Updated

November 10, 2020

Sponsor

EMD Serono Research & Development Institute, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00641537

Brief Title

CLARITY Extension Study

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

February 29, 2008 (Actual)

Primary Completion Date

December 31, 2011 (Actual)

Study Completion Date

December 31, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMD Serono Research & Development Institute, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing-Remitting Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

867 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cladribine Low/Placebo (LLPP)

Arm Type

Placebo Comparator

Arm Title

Cladribine High Dose/Placebo (HLPP)

Arm Type

Placebo Comparator

Arm Title

Cladribine Low/Low Dose (LLLL)

Arm Type

Experimental

Arm Title

Cladribine High/Low Dose (HLLL)

Arm Type

Experimental

Arm Title

Placebo/Cladribine Low Dose (PPLL)

Arm Type

Experimental

Arm Title

Placebo/No Treatment

Arm Type

No Intervention

Arm Title

Cladribine 3.5 mg/kg/No Treatment

Arm Type

No Intervention

Arm Description

Arm Title

Cladribine 5.25 mg/kg/No Treatment

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cladribine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Cladribine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Cladribine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline up to Week 120

Title

Safety Population: Mean Change From Baseline in Absolute Lymphocyte Count, Platelet, Neutrophils and Leukocytes at Week 120

Description

Mean change from baseline in absolute lymphocyte count, platelet, neutrophils and leukocytes at week 120 were reported.

Time Frame

Baseline, Week 120

Title

Safety Population: Mean Change From Baseline in Hemoglobin at Week 120

Description

Mean change from baseline in hemoglobin at Week 120 was reported.

Time Frame

Baseline, Week 120

Title

Safety Population: Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase at Week 120

Description

Mean change from baseline in aspartate aminotransferase and alanine aminotransferase at week 120 were reported.

Time Frame

Baseline, Week 120

Title

Safety Population: Mean Change From Baseline in Bilirubin at Week 120

Description

Mean Change From Baseline in Bilirubin at week 120 was reported.

Time Frame

Baseline, Week 120

Title

Safety Population: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

Description

Time Frame

Baseline up to Week 120

Title

SAFUP Analysis Set: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

Description

Time Frame

Baseline up to Week 120

Title

Safety Population: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies

Description

Time Frame

Baseline up to Week 120

Title

SAFUP Analysis Set: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies

Description

Time Frame

Baseline up to Week 120

Title

Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity

Description

Time Frame

Baseline up to Week 120

Title

Safety Population: Median Time to Recovery From Grade 3 or 4 Hematological and Hepatic Toxicity

Description

Time Frame

Baseline up to Week 120

Title

Safety Population: Mean Time to Recovery From Grade 3 or 4 Hematological and Liver Toxicity

Description

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.

Time Frame

Baseline up to Week 120

Title

Safety Population: Median Time to Nadir of Absolute Lymphocyte Count

Description

Median time to nadir of absolute lymphocyte count was reported.

Time Frame

Baseline up to Week 120

Title

Safety Population: Mean Time to Nadir of Absolute Lymphocyte Count

Description

Mean time to nadir of absolute lymphocyte count was reported.

Time Frame

Baseline up to Week 120

Title

Safety Population: Mean Time to Recovery From Nadir of Absolute Lymphocyte Count to Normal Value

Description

Time Frame

Baseline up to Week 120

Title

Safety Population: Mean Change in Corrected QT (QTc) Interval From Baseline

Description

Time Frame

Baseline, Week 5, 48, 52 and 96

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Responsible

Organizational Affiliation

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Boulder

State/Province

Colorado

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

Research Site

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

Research Site

City

Northbrook

State/Province

Illinois

Country

United States

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

Research Site

City

Ann Arbor

State/Province

Michigan

Country

United States

Facility Name

Research Site

City

Henderson

State/Province

Nevada

Country

United States

Facility Name

Research Site

City

Newark

State/Province

New Jersey

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

Country

United States

Facility Name

Research Site

City

Durham

State/Province

North Carolina

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Ohio

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Research Site

City

Tulsa

State/Province

Oklahoma

Country

United States

Facility Name

Research Site

City

Medford

State/Province

Oregon

Country

United States

Facility Name

Research Site

City

Seattle

State/Province

Washington

Country

United States

Facility Name

Research Site

City

Tacoma

State/Province

Washington

Country

United States

Facility Name

Research Site

City

Charleston

State/Province

West Virginia

Country

United States

Facility Name

Research Site

City

Camperdown

Country

Australia

Facility Name

Research Site

City

Melbourne

Country

Australia

Facility Name

Research Site

City

Victoria

Country

Australia

Facility Name

Research Site

City

Linz

Country

Austria

Facility Name

Research Site

City

Diepenbeek

Country

Belgium

Facility Name

Research Site

City

Esneux

Country

Belgium

Facility Name

Research Site

City

Recife

Country

Brazil

Facility Name

Research Site

City

Pleven

Country

Bulgaria

Facility Name

Research Site

City

Plovdiv

Country

Bulgaria

Facility Name

Research Site

City

Ruse

Country

Bulgaria

Facility Name

Research Site

City

Shuman

Country

Bulgaria

Facility Name

Research Site

City

Sofia

Country

Bulgaria

Facility Name

Research Site

City

Varna

Country

Bulgaria

Facility Name

Research Site

City

Zagora

Country

Bulgaria

Facility Name

Research Site

City

Burnaby

Country

Canada

Facility Name

Research Site

City

Greenfield Park

Country

Canada

Facility Name

Research Site

City

Ottawa

Country

Canada

Facility Name

Research Site

City

Quebec

Country

Canada

Facility Name

Research Site

City

Karlovac

Country

Croatia

Facility Name

Research Site

City

Sisak

Country

Croatia

Facility Name

Research Site

City

Split

Country

Croatia

Facility Name

Research Site

City

Hradec Králové

Country

Czechia

Facility Name

Research Site

City

Olomouc

Country

Czechia

Facility Name

Research Site

City

Praha

Country

Czechia

Facility Name

Research Site

City

Copenhagen

Country

Denmark

Facility Name

Research Site

City

Tallinn

Country

Estonia

Facility Name

Research Site

City

Tartu

Country

Estonia

Facility Name

Research Site

City

Oulu

Country

Finland

Facility Name

Research Site

City

Turku

Country

Finland

Facility Name

Research Site

City

Clermont-Ferrand

Country

France

Facility Name

Research Site

City

Lille

Country

France

Facility Name

Research Site

City

Nancy

Country

France

Facility Name

Research Site

City

Nimes

Country

France

Facility Name

Research Site

City

Paris

Country

France

Facility Name

Research Site

City

Rennes

Country

France

Facility Name

Research Site

City

Saint Herblain

Country

France

Facility Name

Research Site

City

Bochum

Country

Germany

Facility Name

Research Site

City

Frankfurt

Country

Germany

Facility Name

Research Site

City

Giessen

Country

Germany

Facility Name

Research Site

City

Hannover

Country

Germany

Facility Name

Research Site

City

Regensburg

Country

Germany

Facility Name

Research Site

City

Rostock

Country

Germany

Facility Name

Research Site

City

Athens

Country

Greece

Facility Name

Research Site

City

Bari

Country

Italy

Facility Name

Research Site

City

Cagliari

Country

Italy

Facility Name

Research Site

City

Catania

Country

Italy

Facility Name

Research Site

City

Firenze

Country

Italy

Facility Name

Research Site

City

Genova

Country

Italy

Facility Name

Research Site

City

Milano

Country

Italy

Facility Name

Research Site

City

Napoli

Country

Italy

Facility Name

Research Site

City

Padova

Country

Italy

Facility Name

Research Site

City

Roma

Country

Italy

Facility Name

Research Site

City

Riga

Country

Latvia

Facility Name

Research Site

City

Beirut

Country

Lebanon

Facility Name

Research Site

City

Beyrouth

Country

Lebanon

Facility Name

Research Site

City

Kaunas

Country

Lithuania

Facility Name

Research Site

City

Casablanca

Country

Morocco

Facility Name

Research Site

City

Fes

Country

Morocco

Facility Name

Research Site

City

Rabat

Country

Morocco

Facility Name

Research Site

City

Sittard- Geleen

Country

Netherlands

Facility Name

Research Site

City

Gdansk

Country

Poland

Facility Name

Research Site

City

Krakow

Country

Poland

Facility Name

Research Site

City

Lodz

Country

Poland

Facility Name

Research Site

City

Poznan

Country

Poland

Facility Name

Research Site

City

Warszawy

Country

Poland

Facility Name

Research Site

City

Lisboa

Country

Portugal

Facility Name

Research Site

City

Ekaterinburg

Country

Russian Federation

Facility Name

Research Site

City

Kaluga

Country

Russian Federation

Facility Name

Research Site

City

Kazan

Country

Russian Federation

Facility Name

Research Site

City

Kemerovo

Country

Russian Federation

Facility Name

Research Site

City

Kursk

Country

Russian Federation

Facility Name

Research Site

City

Moscow

Country

Russian Federation

Facility Name

Research Site

City

Nizhny Novgorod

Country

Russian Federation

Facility Name

Research Site

City

Novosibirsk

Country

Russian Federation

Facility Name

Research Site

City

Rostov-on-Don

Country

Russian Federation

Facility Name

Research Site

City

Samara

Country

Russian Federation

Facility Name

Reseach Site

City

Saratov

Country

Russian Federation

Facility Name

Research Site

City

St-Petersburg

Country

Russian Federation

Facility Name

Research Site

City

Tomsk

Country

Russian Federation

Facility Name

Research Site

City

Vladimir

Country

Russian Federation

Facility Name

Research Site

City

Yaroslavl

Country

Russian Federation

Facility Name

Research Site

City

Riyadh

Country

Saudi Arabia

Facility Name

Research Site

City

Belgrade

Country

Serbia

Facility Name

Research Site

City

Lausanne

Country

Switzerland

Facility Name

Research Site

City

St. Gallen

Country

Switzerland

Facility Name

Research Site

City

Monastir

Country

Tunisia

Facility Name

Research Site

City

Sfax

Country

Tunisia

Facility Name

Research Site

City

Tunis

Country

Tunisia

Facility Name

Research Site

City

Bursa

Country

Turkey

Facility Name

Research Site

City

Izmir

Country

Turkey

Facility Name

Research Site

City

Kharkov

Country

Ukraine

Facility Name

Research Site

City

Kiev

Country

Ukraine

Facility Name

Research Site

City

Lviv

Country

Ukraine

Facility Name

Research Site

City

Vinnitsa

Country

Ukraine

Facility Name

Research Site

City

Hull

Country

United Kingdom

Facility Name

Research Site

City

London

Country

United Kingdom

Facility Name

Research Site

City

Nottingham

Country

United Kingdom

Facility Name

Research Site

City

Oxford

Country

United Kingdom

Facility Name

Research Site

City

Sheffield

Country

United Kingdom

Facility Name

Research Site

City

Stoke-on-Trent

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

36017797

Citation

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.

Results Reference

derived

PubMed Identifier

36017780

Citation

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.

Results Reference

derived

PubMed Identifier

35003076

Citation

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.

Results Reference

derived

PubMed Identifier

34370275

Citation

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.

Results Reference

derived

PubMed Identifier

33969750

Citation

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.

Results Reference

derived

PubMed Identifier

32447743

Citation

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.

Results Reference

derived

PubMed Identifier

29399054

Citation

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.

Results Reference

derived

Links:

URL

https://clinicaltrials.emdgroup.com/en/trial-details/?id=27820

Description

Trial Awareness and Transparency website

URL

https://medical.emdserono.com/en_US/home.html

Description

US Medical Information website, Medical Resources

Learn more about this trial

CLARITY Extension Study

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CLARITY Extension Study

Relapsing-Remitting Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial