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Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Mavenclad®
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Mavenclad®, Cladribine, Health-related Quality of Life

Eligibility Criteria

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

Inclusion Criteria:

  • Highly active RMS as defined by:
  • One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs).
  • Two or more relapses in the previous year, whether on DMD treatment or not.
  • Expanded Disability Status Scale (EDSS) score less than equals to (<=) 5.0.
  • Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

  • Positive hepatitis C or hepatitis B surface antigen test and/or core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM).
  • Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result.
  • Currently receiving immunosuppressive or myelosuppressive therapy with, for example, monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids.
  • History of tuberculosis, presence of active tuberculosis, or latent tuberculosis
  • Presence of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance Imaging (MRI).
  • Active malignancy.
  • Other protocol defined exclusion criteria could apply.

Sites / Locations

  • Kepler Universitätsklinikum
  • Paracelsus Medical University Salzburg
  • Eva Maida
  • Cliniques Univ. St.-Luc
  • UZ Antwerpen
  • Clinique Saint Pierre
  • FN u sv. Anny Brno
  • FN Hradec Kralove
  • Nemocnice Jihlava, p.o.
  • Fakultni nemocnice Olomouc
  • Fakultni nemocnice Ostrava (11573)
  • Faculty Hospital Kralovske Vinohrad
  • Vseobecna fakultni nemocnice v Praze (11163)
  • Nemocnice Teplice
  • Aalborg Hospital
  • Glostrup University Hospital
  • Odense Univeristy Hospital
  • Matthias Kant
  • Helsinki University Central Hospital
  • Helsinki University Central Hospital
  • Terveystalo Mikkeli
  • Neo Research, Neuro NEO Oy
  • Centre hospitalier de la Côte Basque - Saint Léon
  • Hopital Pellegrin
  • University Hospital of Caen
  • CHRU de Lille
  • Groupe Hospitalier de l'Institut Catholique de Lille - Centre Hospitalier Saint Philibert
  • CHU de Nantes
  • Centre Hospitalier de Gonesse
  • Hôpital de la Pitié-Salpétrière
  • CHU de Poissy
  • CHU Hopital Gabriel Montpied
  • Centre Universitaire de Rouen
  • Hopital Pierre-Paul Riquet - Neurologie
  • CHU Tours - Hôpital Bretonneau
  • Hos. Errikos Dynan
  • 401 Army Hospital
  • Athens Medical Centre
  • Semmelweis Egyetem AOK
  • Uzsoki Utcai Korhaz
  • Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
  • University of Debrecen
  • VALEOMED Kft
  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
  • A.O.U. Ospedali Riuniti Umberto I
  • Ospedale Binaghi, Università di Cagliari,ASL 8 - Centro Sclerosi Multipla
  • Policlinico di Catania
  • Ospedale San Raffaele Giglio
  • Ospedale San Raffaele, IRCCS
  • Instituto Nazionale Neurologico "Carlo Besta"
  • A.O. Universitaria Federico II
  • Seconda Univesità degli Studi di Napoli, AOU
  • Villa Sofia Hospital
  • Azienda Ospedaliera S. Camillo Forlanini (8025)
  • Azienda Ospedaliera Sant'Andrea Università La Sapienza
  • Neurological Center Of Latium
  • Policlinico Tor Vergata
  • Hospital of Lithuanian University of Health Sciences Kaunas
  • Klaipedos Ligonine
  • Vilnius University Hospital Santariskiu Clinics
  • Zuyderland
  • Drammen Hospital
  • COPERNICUS Podmiot Leczn. Sp z o.o.
  • M.A. - LEK A.M.Maciejowscy SC.
  • Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie
  • Centrum Medyczne Medyk
  • Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
  • Instytut Psychiatrii i Neurologii
  • Centrum Neurologii K. Selmaj
  • Hospital de Braga
  • Centro Hospitalar do Porto E.P.E. Hospital de Santo António
  • Univerzitna nemocnica Bratislava
  • Univerzitna nemocnica Martin
  • Fakultna nemocnica Nitra
  • Fakultna nemocnica Trnava
  • C.A.U. de León - H. de León
  • Hospital Arnau de Vilanova
  • Hospital General Universitario Gregorio Marañón (5030)
  • H. U. Quirónsalud Madrid
  • Hospital Universitario de Getafe
  • Hospital Virgen de la Arrixaca
  • Hospital de Sant Joan Despí Moisès Broggi
  • Hospital Universitario Nuestra Senora de la Candelaria (4776)
  • Complejo Hospitalario Universitario de Santiago
  • Hospital Universitario Virgen del Rocio - Servicio de Oncologia
  • Karlstad Hospital (8232)
  • Motala Hospital (11119)
  • Institute of Neurological Sciences
  • Institute of Neurological Sciences
  • GM LCRN - Great Manchester Local Clinical Research Network
  • The Newcastle Hospitals NHS Foundation Trust
  • Morriston Hospital (4232)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mavenclad®

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) Physical Health Composite Summary and Mental Health Composite Summary Scores at Month 24
The MSQOL-54 was a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument. This 54-item instrument generates 12 sub-scales along with two summary scores, and two additional single-item measures. Sub-scales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The two summary scores physical health and mental health are derived from a weighted combination of scale scores. Each composite summary score has a range from 0-100 where higher scores indicate better QOL. A positive change from baseline indicates improvement.

Secondary Outcome Measures

Treatment Global Satisfaction Determined by Treatment Satisfaction Questionnaire Medication Version 1.4 (TSQM v1.4) Scale at Month 6
TSQM version 1.4 was a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Global Satisfaction- Question 12 scored as 1 (not at all confident) to 5 (extremely confident); question 13 scored as 1 (not at all certain) to 5 (extremely certain); and question 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction.

Full Information

First Posted
December 6, 2017
Last Updated
November 9, 2022
Sponsor
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03369665
Brief Title
Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)
Official Title
A 2-Year Prospective Study to Assess Health-related Quality of Life In Subjects With Highly-Active Relapsing Multiple Sclerosis Treated With Mavenclad® (CLARIFY MS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
November 12, 2021 (Actual)
Study Completion Date
November 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of the study was to assess the health-related quality of life (HRQoL) through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active relapsing multiple sclerosis (RMS) particpants treated with Mavenclad® for 2 years (24 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Mavenclad®, Cladribine, Health-related Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
485 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mavenclad®
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mavenclad®
Other Intervention Name(s)
Cladribine
Intervention Description
Participants with Relapsing Multiple Sclerosis (RMS) received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year. Each treatment course consisted of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective year.
Primary Outcome Measure Information:
Title
Change From Baseline in Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) Physical Health Composite Summary and Mental Health Composite Summary Scores at Month 24
Description
The MSQOL-54 was a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument. This 54-item instrument generates 12 sub-scales along with two summary scores, and two additional single-item measures. Sub-scales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The two summary scores physical health and mental health are derived from a weighted combination of scale scores. Each composite summary score has a range from 0-100 where higher scores indicate better QOL. A positive change from baseline indicates improvement.
Time Frame
Baseline, Month 24
Secondary Outcome Measure Information:
Title
Treatment Global Satisfaction Determined by Treatment Satisfaction Questionnaire Medication Version 1.4 (TSQM v1.4) Scale at Month 6
Description
TSQM version 1.4 was a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Global Satisfaction- Question 12 scored as 1 (not at all confident) to 5 (extremely confident); question 13 scored as 1 (not at all certain) to 5 (extremely certain); and question 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction.
Time Frame
At Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Highly active RMS as defined by: One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs). Two or more relapses in the previous year, whether on DMD treatment or not. Expanded Disability Status Scale (EDSS) score less than equals to (<=) 5.0. Other protocol defined inclusion criteria could apply. Exclusion Criteria: Positive hepatitis C or hepatitis B surface antigen test and/or core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM). Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result. Currently receiving immunosuppressive or myelosuppressive therapy with, for example, monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids. History of tuberculosis, presence of active tuberculosis, or latent tuberculosis Presence of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance Imaging (MRI). Active malignancy. Other protocol defined exclusion criteria could apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Kepler Universitätsklinikum
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Paracelsus Medical University Salzburg
City
Salzburg
Country
Austria
Facility Name
Eva Maida
City
Wien
Country
Austria
Facility Name
Cliniques Univ. St.-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Clinique Saint Pierre
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
FN u sv. Anny Brno
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
FN Hradec Kralove
City
Chocen
ZIP/Postal Code
56501
Country
Czechia
Facility Name
Nemocnice Jihlava, p.o.
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava (11573)
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Faculty Hospital Kralovske Vinohrad
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze (11163)
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Nemocnice Teplice
City
Teplice
ZIP/Postal Code
415 29
Country
Czechia
Facility Name
Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Glostrup University Hospital
City
Glostrup
ZIP/Postal Code
DK-2600
Country
Denmark
Facility Name
Odense Univeristy Hospital
City
Odense
Country
Denmark
Facility Name
Matthias Kant
City
Sønderborg
ZIP/Postal Code
6400
Country
Denmark
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
290
Country
Finland
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
Facility Name
Terveystalo Mikkeli
City
Mikkeli
ZIP/Postal Code
50100
Country
Finland
Facility Name
Neo Research, Neuro NEO Oy
City
Turku
Country
Finland
Facility Name
Centre hospitalier de la Côte Basque - Saint Léon
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
Hopital Pellegrin
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
University Hospital of Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Groupe Hospitalier de l'Institut Catholique de Lille - Centre Hospitalier Saint Philibert
City
Lomme
Country
France
Facility Name
CHU de Nantes
City
Nantes Cedex 01
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalier de Gonesse
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital de la Pitié-Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHU de Poissy
City
Poissy Cedex
ZIP/Postal Code
78303
Country
France
Facility Name
CHU Hopital Gabriel Montpied
City
Puy-de-Dome
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Universitaire de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Hopital Pierre-Paul Riquet - Neurologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Tours - Hôpital Bretonneau
City
Tours Cedex
ZIP/Postal Code
37044
Country
France
Facility Name
Hos. Errikos Dynan
City
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
401 Army Hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Athens Medical Centre
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Semmelweis Egyetem AOK
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
University of Debrecen
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
VALEOMED Kft
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
City
Nyiregyhaza
ZIP/Postal Code
4403
Country
Hungary
Facility Name
A.O.U. Ospedali Riuniti Umberto I
City
Ancona
Country
Italy
Facility Name
Ospedale Binaghi, Università di Cagliari,ASL 8 - Centro Sclerosi Multipla
City
Cagliari
ZIP/Postal Code
09126
Country
Italy
Facility Name
Policlinico di Catania
City
Catania
ZIP/Postal Code
95125
Country
Italy
Facility Name
Ospedale San Raffaele Giglio
City
Cefalù
ZIP/Postal Code
90015
Country
Italy
Facility Name
Ospedale San Raffaele, IRCCS
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
Instituto Nazionale Neurologico "Carlo Besta"
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
A.O. Universitaria Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Seconda Univesità degli Studi di Napoli, AOU
City
Napoli
Country
Italy
Facility Name
Villa Sofia Hospital
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Azienda Ospedaliera S. Camillo Forlanini (8025)
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea Università La Sapienza
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Neurological Center Of Latium
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Policlinico Tor Vergata
City
Roma
Country
Italy
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Klaipedos Ligonine
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Clinics
City
Vilnius
ZIP/Postal Code
8661
Country
Lithuania
Facility Name
Zuyderland
City
Sittard-Geleen
ZIP/Postal Code
6131 BG
Country
Netherlands
Facility Name
Drammen Hospital
City
Drammen
ZIP/Postal Code
3004
Country
Norway
Facility Name
COPERNICUS Podmiot Leczn. Sp z o.o.
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
M.A. - LEK A.M.Maciejowscy SC.
City
Katowice
ZIP/Postal Code
40-571
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Centrum Medyczne Medyk
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Instytut Psychiatrii i Neurologii
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Centrum Neurologii K. Selmaj
City
Łódź
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar do Porto E.P.E. Hospital de Santo António
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Univerzitna nemocnica Bratislava
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Univerzitna nemocnica Martin
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
Facility Name
Fakultna nemocnica Nitra
City
Nitra
ZIP/Postal Code
950 01
Country
Slovakia
Facility Name
Fakultna nemocnica Trnava
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Facility Name
C.A.U. de León - H. de León
City
León
ZIP/Postal Code
24071
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Lérida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón (5030)
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
H. U. Quirónsalud Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario de Getafe
City
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital de Sant Joan Despí Moisès Broggi
City
Sant Joan Despí
ZIP/Postal Code
08970
Country
Spain
Facility Name
Hospital Universitario Nuestra Senora de la Candelaria (4776)
City
Santa Cruz De Tenerfie
ZIP/Postal Code
38010
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio - Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Karlstad Hospital (8232)
City
Karlstad
ZIP/Postal Code
651 86
Country
Sweden
Facility Name
Motala Hospital (11119)
City
Motala
ZIP/Postal Code
59185
Country
Sweden
Facility Name
Institute of Neurological Sciences
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Institute of Neurological Sciences
City
Glasgow
Country
United Kingdom
Facility Name
GM LCRN - Great Manchester Local Clinical Research Network
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
The Newcastle Hospitals NHS Foundation Trust
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Morriston Hospital (4232)
City
Swansea West Glamorgan
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports 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 bit.ly/IPD21
IPD Sharing 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
IPD Sharing 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.
IPD Sharing URL
http://bit.ly/IPD21
Links:
URL
https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS700568_0021
Description
Trial Awareness and Transparency website

Learn more about this trial

Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)

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