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Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for Multiple Sclerosis (MS) (CLASSIC-MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03961204
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Brief Summary:
The purpose of this study is to explore the long-term outcomes, durability of effect, and real world treatment patterns in participants previously participating in the Phase 3 oral cladribine in early multiple sclerosis (ORACLE MS) and Oral Cladribine in participants with relapsing remitting multiple sclerosis, extension study (CLARITY/CLARITY-EXT) clinical trials with the study number of 28821 (NCT00725985), 25643 (NCT00213135) and 27820 (NCT00641537) respectively.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Cladribine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 971 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : January 20, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cladribine

Arm Intervention/treatment
Experimental: Cladribine Drug: Cladribine
Participants will not receive any investigational medicinal product (IMP) in the study. Participants will be eligible who had participated in parent studies 25643 (NCT00213135), 27820 (NCT00641537) and 28821 (NCT00725985) and had received Cladribine tablets or placebo.




Primary Outcome Measures :
  1. Percentage of Participants Using Wheelchair Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher [ Time Frame: Within 2 weeks of signing the informed consent form ]
    EDDS is a scale from 0-10 that evaluates a person with MS disability/neurologic function level where 0=normal and 10=death due to MS. Score of 7.0 is defined as unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and transfers alone; up and about in wheelchair some 12 hours a day.


Secondary Outcome Measures :
  1. Percentage of Participants with 3-Month Sustained Expanded Disability Status Scale (EDSS) Score 6.0 or Higher [ Time Frame: Within 2 weeks of signing the informed consent form ]
    EDDS is a scale from 0-10 that evaluates a person with MS disability/neurologic function level where 0= normal and 10= death due to MS. Score of 6.0 is defined as "intermittent or unilateral constant assistance cane, crutch, brace required to walk about 100 meters with or without resting".

  2. Number of Participants in Each Category of Clinical Characteristics [ Time Frame: Within 2 weeks of signing the informed consent form ]
    Clinical characteristics included gender, age/year of birth, race, ethnicity, education, employment status, disease modifying treatment and disease classification (relapsing remitting multiple sclerosis [RRMS] or Secondary Progressive Multiple Sclerosis [SPMS]). Number of participants in each category of clinical characteristics will be reported.

  3. Disease Duration [ Time Frame: Within 2 weeks of signing the informed consent form ]
  4. Relapse Duration [ Time Frame: Within 2 weeks of signing the informed consent form ]
    A relapse will be defined as participant-reported symptoms and objectively observed signs typical of an acute inflammatory demyelinating event in the central nervous system (CNS), developing acutely or sub-acutely, with duration of at least 24 hours, in the absence of fever or infection.

  5. Total Volume of Time Constant 2 (T2) Lesions [ Time Frame: Within 6 weeks of signing the informed consent form ]
    Total Volume of T2 Lesions will be measured by Using Magnetic Resonance Imaging (MRI) Scans

  6. Total Number of Time Constant 2 (T2) Lesions [ Time Frame: Within 6 weeks of signing the informed consent form ]
    T2 Lesions will be measured by Using MRI Scans.

  7. Number of Time Constant 1 (T1) Hypointense Lesions [ Time Frame: Within 6 weeks of signing the informed consent form ]
    T1 Hypointense Lesions will be measured by Using MRI Scans.

  8. Brain Volume [ Time Frame: Within 6 weeks of signing the informed consent form ]
    Brain volume will be measured by Using MRI Scans.

  9. Ventricular Volume [ Time Frame: Within 6 weeks of signing the informed consent form ]
    Ventricular Volume will be measured by Using MRI Scans.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with relapsing remitting multiple sclerosis (RRMS) randomised in CLARITY/CLARITY-EXT clinical trial(s) who have received greater than or equal to (>=) 1 course of in investigational medicinal product (IMP) Cladribine Tablets or placebo
  • Participants with their first clinical demyelinating event randomised in ORACLE MS clinical trial who have received >= 1 course of IMP Cladribine Tablets or placebo
  • Participants who has sign informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol

Exclusion Criteria:

  • Participants who has any uncontrolled disease state other than MS, that in the Investigator's opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
  • Female study participants who are pregnant
  • Participants who are taking Cladribine Tablets as part of another study at the time of the start of this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961204


Contacts
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Contact: US Medical Information 888-275-7376 eMediUSA@emdserono.com
Contact: Communication Center +49 6151 72 5200 service@emdgroup.com

Locations
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Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Additional Information:
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Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT03961204    
Other Study ID Numbers: MS700568_0026
2019-000069-19 ( EudraCT Number )
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
Multiple Sclerosis
Cladribine
High Disease Activity
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cladribine
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs