Clinical Trials Register

Summary
EudraCT Number:	2009-010788-18
Sponsor's Protocol Code Number:	CAMMS03409
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-08-17
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2009-010788-18

A.3

Full title of the trial

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

A.3.2

Name or abbreviated title of the trial where available

CARE-MS Extension Study

A.4.1

Sponsor's protocol code number

CAMMS03409

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Genzyme Corporation
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Genzyme Corporation
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Genzyme Europe B.V.
B.5.2	Functional name of contact point	Medical Information Genzyme Europe
B.5.3	Address:
B.5.3.1	Street Address	Gooimeer 10
B.5.3.2	Town/ city	Naarden
B.5.3.3	Post code	1411 DD
B.5.3.4	Country	Netherlands
B.5.6	E-mail	eumedinfo@genzyme.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	MabCampath
D.2.1.1.2	Name of the Marketing Authorisation holder	Genzyme Europe B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	alemtuzumab
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	alemtuzumab
D.3.9.2	Current sponsor code	alemtuzumab
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Humanised Monoclonal Antibody

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Relapsing Remitting Multiple Sclerosis

E.1.1.1

Medical condition in easily understood language

Relapsing Remitting Multiple Sclerosis

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10063399
E.1.2	Term	Relapsing-remitting multiple sclerosis
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

This open-label, rater-blinded extension study will enroll patients who have relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab [CAMMS223, CAMMS323 also known as CARE-MS I, or CAMMS324 also known as CARE-MS II].
The main purpose of this study is:
To examine the long term safety and efficacy of alemtuzumab treatment in patients who received alemtuzumab as their study treatment in one of the prior studies.

E.2.2

Secondary objectives of the trial

Secondary objectives are:
●To examine the safety and efficacy of initial alemtuzumab treatment in this study for patients who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies.
●To determine if and when further alemtuzumab treatment is needed, and the safety and efficacy of this "as needed" treatment. This applies both to patients who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

QT substudy (only in selected countries): To assess the potential effects of a 5-day, 12 mg/day, IV alemtuzumab treatment cycle on cardiac repolarization as detected by prolongation of the QT corrected (QTc) interval will be performed at selected sites. Approximately 55 patients formerly treated with interferon beta-1a in prior studies will be enrolled in which they will have ECGs and corresponding pharmacokinetic (PK) samplings performed prior to and during the cycle of alemtuzumab dosing.

Biomarker: For research purposes and on a voluntary basis, a blood
sample will be collected from consenting patients for exploratory
analysis of genetic variations related to MS disease and/or the effects of
alemtuzumab.

E.3

Principal inclusion criteria

Patients must meet ONE of the following criteria to participate in this study:
1 Received alemtuzumab in CAMMS323 or CAMMS324, completed the 2-year study period, and have NOT subsequently received disease modifying treatment (other than glatiramer acetate or interferon beta)
2 Received Rebif® in CAMMS323 or CAMMS324, completed the 2-year study period, and have NOT subsequently received alternative disease modifying treatments (other than glatiramer acetate or another interferon beta)
3 Participated in CAMMS223.

E.4

Principal exclusion criteria

1 Any alemtuzumab patient from CAMMS223, CAMMS323, or CAMMS324 who has received alemtuzumab off-label (ie, outside of one of the prior Genzyme-sponsored studies) or is participating in any other
investigational study, unless approved by Genzyme. In addition, these
patients must be screened for disqualifying safety concerns before
receiving alemtuzumab retreatment.
2 Any Rebif® patient from CAMMS223, CAMMS323, or CAMMS324 who
meets any of the following criteria. In addition, these patients must be
screened for disqualifying safety concerns before receiving alemtuzumab
treatment.
a)Does not wish to receive alemtuzumab;
b) Ongoing participation in any other investigational study , unless
approved by Genzyme;
c)Has received alemtuzumab off-label (ie, outside of one of the prior
Genzyme-sponsored studies);
d)Known bleeding disorder or therapeutic anticoagulation;
e)Diagnosis of idiopathic thrombocytopenia purpura or other
autoimmune hematologic abnormality;
f)History of malignancy, except basal cell skin carcinoma;
g)Intolerance of pulsed corticosteroids, especially a history of steroid
psychosis
h)Significant Autoimmune disorder (other than MS);
i)Major psychiatric disorder or epileptic seizures not adequately
controlled by treatment;
j)Active infection or high risk for infection
k)Unwilling to use a reliable and acceptable contraceptive method during
and for at least 6 months following each alemtuzumab treatment cycle
(fertile patients only).

E.5 End points

E.5.1

Primary end point(s)

Primary outcome measures are:
• Time to Sustained Accumulation of Disability (SAD)
• Relapse Rate

E.5.1.1

Timepoint(s) of evaluation of this end point

48 months

E.5.2

Secondary end point(s)

Secondary outcome measures are:
• Time to sustained reduction in disability (SRD) as measured by the EDSS (Expanded Disability Status Scale)
• Change over time in EDSS scores
• Change over time in MRI findings

E.5.2.1

Timepoint(s) of evaluation of this end point

48 months

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Various other exploratory secondary and tertiary endpoints

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Information not present in EudraCT

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

rater blinded

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Australia

Brazil

Canada

Croatia

Israel

Mexico

Russian Federation

Serbia

Ukraine

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

For each patient, the study will end 48 months (4 years) after enrollment in this study.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1