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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 1 October 2018
Main ID:  EUCTR2017-002511-34-NL
Date of registration: 17/04/2018
Prospective Registration: Yes
Primary sponsor: Academisch Medisch Centrum
Public title: Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP (OPTIC trial)
Scientific title: Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP (OPTIC trial) - OPTIC trial
Date of first enrolment: 26/09/2018
Target sample size: 96
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002511-34
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Netherlands
Contacts
Name: Filip Eftimov   
Address:  Meibergdreef 9 1105 AZ Amsterdam Netherlands
Telephone: +310205668728
Email: f.eftimov@amc.uva.nl
Affiliation:  Academisch Medisch Centrum
Name: Filip Eftimov   
Address:  Meibergdreef 9 1105 AZ Amsterdam Netherlands
Telephone: +310205668728
Email: f.eftimov@amc.uva.nl
Affiliation:  Academisch Medisch Centrum
Key inclusion & exclusion criteria
Inclusion criteria:
Inclusion of patients is based on the presence of active disease and fulfillment of the probable or definite
EFNS/PNS criteria for CIDP. All new and untreated adult patients are eligible for the study. In addition we will include CIDP patients, treated previously, who have a disease relapse after a remission of at least 1 year, and patients who have responded to their first course of IVIg in the last three months but deteriorated afterwards.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 96
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
1) Presence of IgM paraproteinemia , anti-MAG antibodies or CIDP specific antibodies associated with poor treatment response to IVIg
2) Use of drugs associated with a demyelinating neuropathy
3) Use of any immunosuppressive or immunomodulatory drugs in previous 6 months (except for a single loading dose of IVIg within 3 months), with the exception of low dose prednisone (20 mg or less for the duration of two weeks).
4) Known serious adverse events with previous IVIg or corticosteroid treatment
5) One of more of the risk factors associated with increased risk of adverse events of IVIg or IVMP or conditions that could lead to unblinding of treatment (i.e. diabetes; IgA deficiency; gastric ulcers; psychosis; severe hypertension (180/110 mmHg or more on repeated measurements); hypocalcaemia (lower than 2.20 mmol/L, corrected for albumin); moderate or severe heart failure; severe cardiovascular disease (i.e. more than one myocardial infarction and or ischemic stroke); renal failure (glomerulal filtratrion rate < 30 ml/min)
6) History of osteoporosis or osteoporotic fractures
7) Known malignancy with survival expectancy of less than 1 year
8) Bodyweight more than 120 kg
9) Pregnancy or nursing mother; intention to become pregnant during the course of the study; female patients of childbearing potential either not using or not willing to use a medically reliable method of contraception for the entire duration of the study
10) Cataract
11) Psychosis
12) Poor dental status
13) Legally incompetent adults
14) Lack of written informed consent



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Chronic inflammatory demyelinating polyneuropathy (CIDP)
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Methylprednisolone (Solu-Medrol)
Product Name: Methylprednisolon (Solu-Medrol)
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: Sodium Chloride 0.9%
Product Name: Sodium Chloride 0.9%
Product Code: RVG 56083
Pharmaceutical Form: Solution for infusion

Primary Outcome(s)
Main Objective: Primary objective of this randomized controlled trial is to assess whether combining IVIg and IVMP leads to more frequent long-term remission in CIDP compared to treatment with IVIg alone.
Primary end point(s): Primary outcome is the number of patients in remission at 1 year after start of an 18 weeks treatment period. Remission is defined as sustained improvement without the need for further treatment. Improvement is defined as improvement by at least the minimal clinical important difference (MCID) on the I-RODS and/or improvement of one or more points on the INCAT disability scale at 18 weeks compared to baseline. Sustained is defined as no deterioration between 18 weeks and 52 weeks, i.e. difference on the I-RODS of less than the individual MCID difference and one or more points on the INCAT disability scale. Patients will be considered as a treatment failure if they 1) receive additional CIDP treatment during the 18-week intervention period, 2) do not improve at 18 weeks, 3) restart CIDP treatment for any reason between 18 and 52 weeks, or 4) do not show a sustained improvement at 52 weeks as defined above.
Secondary Objective: Secondary objectives are to explore whether this leads to a higher and faster rate of improvement and whether this combination reduces CIDP associated health care costs en increases quality of life.
Timepoint(s) of evaluation of this end point: Primary endpoint will be evaluated at 52 weeks.
Secondary Outcome(s)
Secondary end point(s): 1) The number of patients with improvement on disability equal or more than the MCID;
2) Time to improvement (= MCID) on disability;
3) Mean change in disability;
4) Mean change in grip strength;
5) Mean change in muscle strength;
6) Mean change in sensory impairment (INCAT SS);
7) Mean change in fatigue;
8) Mean change in pain;
9) Mean change in health related quality of life (HRQL);
10) Number of (serious) adverse events (including corticosteroid associated adverse events);
11) Care use and overall healthcare-related costs;

Timepoint(s) of evaluation of this end point: At 18 and 52 weeks. Measuring of these parameters is done consistently (table 1 and 2 in the study protocol, version 4.4.) in the intervention and follow up period. Main secondary outcomes are evaluated at 18 and 52 weeks. Secondary outcomes are also determined according to follow-up protocol (the schedule of which is refered to previously) in case an early endpoint is reached.
Secondary ID(s)
V1.0.14062017
Source(s) of Monetary Support
Princes Beatrix Spierfonds
Sanquin
ZonMW
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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