Chronic Inflammatory Demyelinating PolyradiculopathyPhase 3MYCOPIDNCT02494505
Interest of Mycophenolate for CIDP Weaning
A Phase 3 study testing Mycophenolate Mofetil in people with Chronic Inflammatory Demyelinating Polyradiculopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective is to study if the mycophenolate could decrease the proportion of patients who relapse during the IVIG tapering period and after the IVIG withdrawal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyradiculopathy
- What is being tested?
- Mycophenolate Mofetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2013to 9 May 2018
- Phase
- Phase 3
- 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
- Patient older than eighteen
- Written informed consent for study participation
- Definite or probable CIDP according to EFNS/PNS criteria or atypical CIDP (need to meet clinical EFNS/PNS criteria and at least 2 criteria among the EFNS/PNS supplementary criteria)
- Being responder (= decrease of at least 1 point on the ONLS score after IVIG) and dependent to IVIG (= increase of at least 1 point on the ONLS score after IVIG withdrawal or during the tapering period)
- Having received at least 3 courses of IVIG
- Negative pregnancy test for women of child-bearing age
Who cannot join
- No social security benefit
- Pregnancy or intention to become pregnant
- Nursing mother
- Recent or active VIH or hepatitis B or C , or lyme infections
- Monoclonal IgM gammapathy with anti MAG antibodies or CANOMAD syndrome
- Neutropenia < 1G/L
Show all 11Show fewer
- Malignancy during the 10 years before the inclusion
- Patients having received Mycophenolate
- History of allergy to mycophenolate or placebo excipient
- Patients having received immunosuppressive drugs during the 3 months period before the inclusion
- Patients receiving : plasma exchange, magnesium hydroxide, aluminium hydroxide, cholestyramine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)
The main objective is to study if the mycophenolate could decrease the proportion of patients who relapse during the IVIG tapering period and after the IVIG withdrawal.
Read the detailed description
The secondary objectives are :
- Study if the mycophenolate could improve the proportion of withdrew patients.
- Study if the mycophenolate could improve the reduction of IVIG dose or could prolong the interval between two courses of IVIG compared to the baseline interval at month 12 and month 24 (= sparing treatment criteria).
- Study if mycophenolate could short the delay to perform the IVIG withdrawal.
- Study if mycophenolate could improve the clinical scores (ONLS, R-ODS MRC, INCAT sensory, 10 meters test) or pain score at month 12 and month 24.
- Study if mycophenolate could improve the quality of life at month12 and month 24.
- Identify clinical, biological and electrophysiological factors associated with withdrawal.
- To assess the pharmacokinetics factors (Area under the curve measuring the exposure to mycophenolate) and the pharmacogenetic factors (cytochrome and carrier, FcgammaR) associated with withdrawal.
- Evaluate the tolerance of Mycophenolate in this new indication.
- Being tested
- Mycophenolate Mofetil, placebo
- Keywords
- chronic inflammatory demyelinating polyradiculopathy, intravenous immunoglobulin (IVIG), withdrawal, quality of life, Clinical trial, cost
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2g/day per os
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| mycophenolate mofetil | Experimental | Not described Receives: Drug: Mycophenolate Mofetil |
| placebo | Placebo comparator | placebo pills Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of a relapse during the tapering off period
occurrence of a relapse during the tapering off period (up to 18 months after baseline) or after the withdrawal during the monitoring period.
(the withdrawal is defined by the ability to reach the last day of IVIG treatment)
Measured: up to 18 months
Secondary outcomes (21)
Proportion of withdrew patients
Measured: 6 months after the withdrawal
Proportion of withdrew patients at the end of the study
Measured: 24 months
Sparing treatment (composite criteria)
extension of the mean interval between IVIG courses at month 12 and month 24 compared to baseline, reduction of the total cumulative dose of IVIG at month 12 and month 24 in the mycophenolate group
Measured: 24 months
Time to reach the withdrawal
Measured: 24 months
EVA pain score
Measured: 12 months
EVA pain score
Measured: 24 months
ONLS scale
Measured: 12 months
ONLS scale
Measured: 24 months
R-ODS scale
Measured: 12 months
R-ODS scale
Measured: 24 months
MRC scale
Measured: 12 months
MRC scale
Measured: 24 months
INCAT sensory test
Measured: 12 months
INCAT sensory test
Measured: 24 months
10 meters test
Measured: 12 months
10 meters test
Measured: 24 months
SF-36
Quality of life scale
Measured: 12 months
SF-36
Quality of life scale
Measured: 24 months
Nottingham scale
Quality of life scale
Measured: 12 months
Nottingham scale
Quality of life scale
Measured: 24 months
global cost
Comparison of the global cost in each group
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study start18 Nov 2013
- Primary completion9 May 2018
- Study completion9 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyradiculopathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karine Viala, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494505
- Sponsor's protocol ID
- P110148
- Acronym
- MYCOPID
- Status last verified
- Mar 2019
- First submitted
- 10 Jun 2015
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)
- ClinicalTrials.gov ID
- NCT02494505
- Acronym / sponsor ID
- MYCOPID / P110148
- Keywords
- chronic inflammatory demyelinating polyradiculopathy, intravenous immunoglobulin (IVIG), withdrawal, quality of life, Clinical trial, cost
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 18 Nov 2013 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 10 Jul 2015 (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.
The main objective is to study if the mycophenolate could decrease the proportion of patients who relapse during the IVIG tapering period and after the IVIG withdrawal.
Detailed description
The secondary objectives are :
- Study if the mycophenolate could improve the proportion of withdrew patients.
- Study if the mycophenolate could improve the reduction of IVIG dose or could prolong the interval between two courses of IVIG compared to the baseline interval at month 12 and month 24 (= sparing treatment criteria).
- Study if mycophenolate could short the delay to perform the IVIG withdrawal.
- Study if mycophenolate could improve the clinical scores (ONLS, R-ODS MRC, INCAT sensory, 10 meters test) or pain score at month 12 and month 24.
- Study if mycophenolate could improve the quality of life at month12 and month 24.
- Identify clinical, biological and electrophysiological factors associated with withdrawal.
- To assess the pharmacokinetics factors (Area under the curve measuring the exposure to mycophenolate) and the pharmacogenetic factors (cytochrome and carrier, FcgammaR) associated with withdrawal.
- Evaluate the tolerance of Mycophenolate in this new indication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mycophenolate mofetil | Experimental | Drug: Mycophenolate Mofetil |
| placebo | Placebo comparator | Drug: placeboplacebo pills |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient older than eighteen
- Written informed consent for study participation
- Definite or probable CIDP according to EFNS/PNS criteria or atypical CIDP (need to meet clinical EFNS/PNS criteria and at least 2 criteria among the EFNS/PNS supplementary criteria)
- Being responder (= decrease of at least 1 point on the ONLS score after IVIG) and dependent to IVIG (= increase of at least 1 point on the ONLS score after IVIG withdrawal or during the tapering period)
- Having received at least 3 courses of IVIG
Key exclusion criteria (11 listed)
- No social security benefit
- Pregnancy or intention to become pregnant
- Nursing mother
- Recent or active VIH or hepatitis B or C , or lyme infections
- Monoclonal IgM gammapathy with anti MAG antibodies or CANOMAD syndrome
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 |
|---|---|---|
| Mycophenolate Mofetil2g/day per os | Drug | mycophenolate mofetil |
| placebo | Drug | placebo |
Primary outcome
occurrence of a relapse during the tapering off period
Time frame: up to 18 months
occurrence of a relapse during the tapering off period (up to 18 months after baseline) or after the withdrawal during the monitoring period. (the withdrawal is defined by the ability to reach the last day of IVIG treatment)
21 secondary outcomes
Proportion of withdrew patients
Time frame: 6 months after the withdrawal
Proportion of withdrew patients at the end of the study
Time frame: 24 months
Sparing treatment (composite criteria)
Time frame: 24 months
Time to reach the withdrawal
Time frame: 24 months
EVA pain score
Time frame: 12 months
EVA pain score
Time frame: 24 months
ONLS scale
Time frame: 12 months
ONLS scale
Time frame: 24 months
R-ODS scale
Time frame: 12 months
R-ODS scale
Time frame: 24 months
MRC scale
Time frame: 12 months
MRC scale
Time frame: 24 months
INCAT sensory test
Time frame: 12 months
INCAT sensory test
Time frame: 24 months
10 meters test
Time frame: 12 months
10 meters test
Time frame: 24 months
SF-36
Time frame: 12 months
SF-36
Time frame: 24 months
Nottingham scale
Time frame: 12 months
Nottingham scale
Time frame: 24 months
global cost
Time frame: 24 months
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 15 Mar 2019.
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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.
Karine Viala, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mycophenolate Mofetil in people with Chronic Inflammatory Demyelinating Polyradiculopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 11 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 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
occurrence of a relapse during the tapering off period (time frame: up to 18 months). 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 15 Mar 2019.