Relapsing-remitting Multiple SclerosisPhase 4EMERALDNCT02205489
Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA
A Phase 4 study testing Alemtuzumab GZ402673, cetirizine and ranitidine in people with Relapsing-remitting Multiple Sclerosis, run by Genzyme, a Sanofi Company at 20 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- Alemtuzumab GZ402673, cetirizine and ranitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 20 sitesin 4 countries
- Study dates
- Oct 2014to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult RRMS patients who will be initiating treatment with Lemtrada according to local approved label.
- Signed written informed consent.
Who cannot join
- 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.
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- Patient who has withdrawn consent before enrollment (starting from signed informed consent form).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.
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
France10 sites
Investigational Site Number 250009
Dijon, 21000
Investigational Site Number 250005
Lille, 59037
Investigational Site Number 250001
Lyon Bron, 69677
Investigational Site Number 250006
Nancy
Investigational Site Number 250010
Nantes, 44093
Investigational Site Number 250007
Nîmes, 30029
Investigational Site Number 250008
Paris, 75970
Investigational Site Number 250004
Rennes, 35033
Investigational Site Number 250003
Strasbourg, 67098
Investigational Site Number 250002
Toulouse, 31200
Spain6 sites
Investigational Site Number 724001
Barcelona, 08035
Investigational Site Number 724005
Bilbao, 48013
Investigational Site Number 724002
Madrid, 28040
Investigational Site Number 724006
Málaga, 29010
Investigational Site Number 724003
Seville, 41071
Investigational Site Number 724004
Valencia, 46009
Belgium2 sites
Investigational Site Number 056002
Bruges, 8000
Investigational Site Number 056001
Brussels, 1070
Netherlands2 sites
Investigational Site Number 528001
Breda, 4818CK
Investigational Site Number 528002
Rotterdam, 3079DZ
About this study
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
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.
Read the 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.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- Alemtuzumab GZ402673, cetirizine, ranitidine, methylprednisolone, aciclovir
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alemtuzumab GZ402673Drug
Also called Lemtrada
Pharmaceutical form:concentration for solution Route of administration: intravenous infusion
cetirizineDrug
Pharmaceutical form:tablet Route of administration: oral
ranitidineDrug
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:solution Route of administration: intravenous
aciclovirDrug
Pharmaceutical form:tablet Route of administration: oral
esomeprazoleDrug
Pharmaceutical form:tablet Route of administration: oral
ibuprofenDrug
Pharmaceutical form:tablet Route of administration: oral
paracetamolDrug
Pharmaceutical form:tablet Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| GZ402673 LEMTRADA | Experimental | 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. Receives: Drug: Alemtuzumab GZ402673; Drug: cetirizine; Drug: ranitidine; Drug: methylprednisolone; Drug: aciclovir; Drug: esomeprazole; Drug: ibuprofen; Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 30 days in the first treatment course and the second treatment course, respectively
Proportion of IARs
Measured: up to 30 days in the first treatment course and the second treatment course, respectively
Proportion and type of serious IARs
Measured: up to 30 days in the first treatment course and the second treatment course, respectively
Proportion by type (as defined by clinical symptoms)
Measured: up to 30 days in the first treatment course and the second treatment course, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205489
- Sponsor's protocol ID
- LPS13650
- Other IDs
- 2014-000092-62, U1111-1153-3922, 2014
- Acronym
- EMERALD
- Status last verified
- Jun 2016
- First submitted
- 29 Jul 2014
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02205489
- Acronym / sponsor ID
- EMERALD / LPS13650
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GZ402673 LEMTRADA | Experimental | Drug: Alemtuzumab GZ402673, Drug: cetirizine, Drug: ranitidine, Drug: methylprednisolone, Drug: aciclovir, Drug: esomeprazole, Drug: ibuprofen, Drug: paracetamolFirst 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult RRMS patients who will be initiating treatment with Lemtrada according to local approved label.
- Signed written informed consent.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alemtuzumab GZ402673Also: LemtradaPharmaceutical form:concentration for solution Route of administration: intravenous infusion | Drug | GZ402673 LEMTRADA |
| cetirizinePharmaceutical form:tablet Route of administration: oral | Drug | GZ402673 LEMTRADA |
| ranitidinePharmaceutical form:tablet Route of administration: oral | Drug | GZ402673 LEMTRADA |
| methylprednisolonePharmaceutical form:tablet Route of administration: oral | Drug | GZ402673 LEMTRADA |
| methylprednisolonePharmaceutical form:solution Route of administration: intravenous | Drug | GZ402673 LEMTRADA |
| aciclovirPharmaceutical form:tablet Route of administration: oral | Drug | GZ402673 LEMTRADA |
| esomeprazolePharmaceutical form:tablet Route of administration: oral | Drug | GZ402673 LEMTRADA |
| ibuprofenPharmaceutical form:tablet Route of administration: oral | Drug | GZ402673 LEMTRADA |
| paracetamolPharmaceutical form:tablet Route of administration: oral | Drug | GZ402673 LEMTRADA |
Primary outcome
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
Proportion of IARs
Time frame: up to 30 days in the first treatment course and the second treatment course, respectively
Proportion and type of serious IARs
Time frame: up to 30 days in the first treatment course and the second treatment course, respectively
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alemtuzumab GZ402673, cetirizine and ranitidine in people with Relapsing-remitting Multiple Sclerosis, run by Genzyme, a Sanofi Company at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, Spain, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.