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Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA (EMERALD)

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ClinicalTrials.gov Identifier: NCT02205489
Recruitment Status : Completed
First Posted : July 31, 2014
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:

Primary Objective:

To assess the distribution of IARs by severity grade when LEMTRADA is administered to RRMS patients who will be medicated according to specified algorithm designed to manage infusion associated reactions.


Condition or disease Intervention/treatment Phase
Relapsing-remitting Multiple Sclerosis Drug: Alemtuzumab GZ402673 Drug: cetirizine Drug: ranitidine Drug: methylprednisolone Drug: aciclovir Drug: esomeprazole Drug: ibuprofen Drug: paracetamol Phase 4

Detailed Description:

The total duration of participation in the study per patient is approximately 13.5 months.

After the end of the second course of LEMTRADA treatment, patients will be followed by their physician in a regular healthcare setting until 48 months safety monitoring period is completed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADA
Study Start Date : October 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab

Arm Intervention/treatment
Experimental: GZ402673 LEMTRADA
First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
Drug: Alemtuzumab GZ402673
Pharmaceutical form:concentration for solution Route of administration: intravenous infusion
Other Name: Lemtrada

Drug: cetirizine
Pharmaceutical form:tablet Route of administration: oral

Drug: ranitidine
Pharmaceutical form:tablet Route of administration: oral

Drug: methylprednisolone
Pharmaceutical form:tablet Route of administration: oral

Drug: methylprednisolone
Pharmaceutical form:solution Route of administration: intravenous

Drug: aciclovir
Pharmaceutical form:tablet Route of administration: oral

Drug: esomeprazole
Pharmaceutical form:tablet Route of administration: oral

Drug: ibuprofen
Pharmaceutical form:tablet Route of administration: oral

Drug: paracetamol
Pharmaceutical form:tablet Route of administration: oral




Primary Outcome Measures :
  1. Proportion of IARs that are graded mild according to the Common Toxicity Criteria (CTC). An IAR is any adverse event occurring during or within 24 hours of LEMTRADA infusion. [ Time Frame: up to 30 days in the first treatment course and the second treatment course, respectively ]
  2. Proportion of IARs [ Time Frame: up to 30 days in the first treatment course and the second treatment course, respectively ]
  3. Proportion and type of serious IARs [ Time Frame: up to 30 days in the first treatment course and the second treatment course, respectively ]
  4. Proportion by type (as defined by clinical symptoms) [ Time Frame: up to 30 days in the first treatment course and the second treatment course, respectively ]


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

Inclusion criteria:

  • Adult RRMS patients who will be initiating treatment with Lemtrada according to local approved label.
  • Signed written informed consent.

Exclusion criteria:

  • Previously treated with LEMTRADA.
  • Contraindications to LEMTRADA according to the labeling in the country.
  • Any known contraindications to the symptomatic therapy used in the infusion management guidance based on their local approved label.
  • Currently participating in another investigational interventional study.
  • Any technical/administrative reason that makes it impossible to enroll the patient in the study.
  • Patient is the Investigator or any Sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
  • Patient who has withdrawn consent before enrollment (starting from signed informed consent form).
  • Despite screening of the patient, enrolment is stopped at the study level.
  • Woman of childbearing potential not protected by highly-effective method(s) of birth control (as defined in a local protocol amendment in case of specific local requirement) and/or who are unwilling or unable to be tested for pregnancy.
  • Pregnancy (defined as positive beta human chorionic gonadotropin (β-HCG) blood test), breast feeding.
  • Known infection with latent tuberculosis or active tuberculosis.
  • Known infection with Hepatitis B, Hepatitis C.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


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): NCT02205489


Locations
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Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02205489    
Other Study ID Numbers: LPS13650
2014-000092-62
U1111-1153-3922 ( Other Identifier: UTN )
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cetirizine
Acyclovir
Ibuprofen
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Alemtuzumab
Esomeprazole
Ranitidine
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents