Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP (OPTIC trial)

Phase 3

Suspended

• Conditions: Chronic Inflammatory Demyelinating Polyneuropathy; 10034606; CIDP

• Registration Number: NL-OMON50340
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 60

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.
Deterioration after treatment is defined as any deterioration warranting
treatment as judged by the treating physician.

Exclusion Criteria

1) Presence of IgM paraproteinemia and/or 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 less than 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) Known pulmonary embolism or other deep venous thrombosis in patient*s
medical history, without current anticoagulant therapy
14) Legally incompetent adults
15) Lack of written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified