Cognition and HRQoL in Adults With Highly-active RMS in Year 3 and 4 After Initial Mavenclad® Dose (CLARIFY MS Extension)

NCT04776213 | Completed Phase 4 Results

• 2 other identifiers: MS700568_01582020-003874-30
• Study Type: interventional
• Target: 280
• Locations: 10 countries
• Sites: 60

Brief Summary

The purpose of the study was the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (RMS). This was the extension study to CLARIFY MS (NCT03369665), to assess cognitive impairment and health related quality of life (HRQoL) in participants with highly active RMS, at 4 years after initial dose of Mavenclad® tablets.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Health related quality of life; Mavenclad®; Relapsing Multiple Sclerosis; Cladribine; Cognitive impairment cognition; Fatigue

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With No or Minimal Decline in Cognitive Function, Defined As an Improved or Stable Symbol Digit Modalities Test (SDMT) Score or a Decline of 4 Points or Less in the SDMT Score, From Baseline of Parent Study to Month 48

  The SDMT is a test of information processing speed. It consists of 9 abstract symbols. Each symbol is paired with a single digit. The participant is provided with a "key", showing each symbol digit pair. In addition, the participants are shown several rows of the 9 symbols, which are arranged pseudo-randomly, without the digit. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 seconds. The SDMT score ranges from 0 to 110 where higher scores indicated improvement and lower scores indicated worsening.

  Baseline (Baseline of parent study [NCT03369665]) and Month 48 after initial dose of Mavenclad® in parent study (NCT03369665)

Secondary Outcomes (2)

• Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Composite Summary Scores at 4 Years

  Baseline (baseline of parent study [NCT03369665]), 4 years after initial dose of Mavenclad® in parent study (NCT03369665)

• Change From Month 24 in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Composite Summary Scores at 4 Years

  Month 24 after initial dose of Mavenclad® in parent study (NCT03369665), 4 years after initial dose of Mavenclad® in parent study (NCT03369665)

Study Arms (1)

Mavenclad®

EXPERIMENTAL

Drug: Mavenclad®

Interventions

Mavenclad® DRUG

This low interventional extension study involves the follow up of participants in the parent study. The participants were followed up for an additional 2 year period (until 4 years after initial administration of Mavenclad® tablets), during which the participants were not treated with Mavenclad®, as per European Medicines Agency (EMA) label of Mavenclad®.

Mavenclad®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have at least CLARIFY MS Baseline data on Symbol Digit Modalities Test (SDMT)
• Received at least a single dose of cladribine tablets in the CLARIFY MS study
• Completed the Final Study Visit (M24) of the CLARIFY MS study
• Capable of giving signed informed consent, as indicated in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol

You may not qualify if:

• Participant is considered by the Investigator and Sponsor, for any reason, to be an unsuitable candidate for the study
• Participation in other studies.

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (60)

Eva Maida

Vienna, Austria

Location

FN u sv. Anny Brno

Brno, Czechia

Location

FN Hradec Králové

Hradec Králové, Czechia

Location

Nemocnice Jihlava, p.o.

Jihlava, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, Czechia

Location

Fakultni nemocnice Ostrava

Ostrava, Czechia

Location

Faculty Hospital Kralovske Vinohrady

Prague, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Location

Nemocnice Teplice

Teplice, Czechia

Location

Glostrup Sygehus

Glostrup Municipality, Denmark

Location

Odense Univeristy Hospital

Odense, Denmark

Location

Centre hospitalier de la Côte Basque - Saint Léon

Bayonne, France

Location

Pellegrin

Bordeaux, France

Location

CHU de la Côte de Nacre

Caen, France

Location

Centre Hospitalier de Gonesse

Gonesse, France

Location

CHRU de Lille Hôpital Roger Salengro

Lille, France

Location

CHU Hôpital Nord Laennec

Nantes, France

Location

Hôpital de la Pitié-Salpétrière

Paris Cédex 13, France

Location

CHU de Poissy

Poissy, France

Location

Centre Universitaire de Rouen

Rouen, France

Location

CHU Tours - Hôpital Bretonneau

Tours, France

Location

Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet

Budapest, Hungary

Location

Semmelweis University II

Budapest, Hungary

Location

Uzsoki Utcai Korhaz

Budapest, Hungary

Location

Debreceni Egyetem Orvos- és Egészségtudományi Centrum

Debrecen, Hungary

Location

Valeomed Kft

Esztergom, Hungary

Location

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór

Nyíregyháza, Hungary

Location

A.O.U. Ospedali Riuniti Umberto

Ancona, Italy

Location

University of Cagliari

Cagliari, Italy

Location

PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

Catania, Italy

Location

Ospedale San Raffaele Giglio

Cefalù, Italy

Location

Instituto Nazionale Neurologico "Carlo Besta"

Milan, Italy

Location

Ospedale San Raffaele, IRCCS

Milan, Italy

Location

A.O. Universitaria Federico II

Napoli, Italy

Location

Policlinico Università della Campania L. Vanvitelli

Napoli, Italy

Location

A.O. Ospedali Riuniti Villa Sofia-Cervello U.O. Endocrinolog

Palermo, Italy

Location

Azienda Ospedaliera S. Camillo Forlanini

Roma, Italy

Location

Neurological Center of Latium

Roma, Italy

Location

Ospedale Sant'Andrea Neurologia - Università La Sapienza

Roma, Italy

Location

Policlinico Tor Vergata

Roma, Italy

Location

Zuyderland

Sittard-Geleen, Netherlands

Location

COPERNICUS Podmiot Leczn. Sp z o.o.

Gdansk, Poland

Location

M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM

Katowice, Poland

Location

Centrum Neurologii Krzysztof Selmaj

Lodz, Poland

Location

Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie

Lodz, Poland

Location

Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

Lublin, Poland

Location

Centrum Medyczne Medyk

Rzeszów, Poland

Location

Instytut Psychiatrii i Neurologii - Dept of Neurology II

Warsaw, Poland

Location

Neuropoint s.r.o

Bratislava, Slovakia

Location

Univerzitna nemocnica Martin

Martin, Slovakia

Location

Fakultna nemocnica Nitra

Nitra, Slovakia

Location

Fakultna nemocnica Trnava

Trnava, Slovakia

Location

Hospital Universitario de Getafe

Getafe, Spain

Location

C.A.U. de León - H. de León

León, Spain

Location

Hospital Arnau de Vilanova

Lleida, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Spain

Location

Hospital de Sant Joan Despí Moisès Broggi

Sant Joan Despí, Spain

Location

Hospital Universitario Nuestra Senora de la Candelaria

Santa Cruz de Tenerife, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Communication Center
• Organization: Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 1, 2021
• Study Start: February 23, 2021
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: May 28, 2024
• Results First Posted: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
• Access Criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

Locations

HU (6); NL (1); DK (2); CZ (8); AU (1); FR (10); IT (13); PL (7); SL (4); ES (8)