OPTIC Trial
Research type
Research Study
Full title
Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP
IRAS ID
240646
Contact name
Michael Lunn
Contact email
Sponsor organisation
Academic Medical Centre, Amsterdam, NL
Eudract number
2017-002511-34
ISRCTN Number
ISRCTN15893334
Duration of Study in the UK
2 years, 5 months, 2 days
Research summary
Chronic inflammatory demyelinating polyneuropathy (CIDP) is an inflammatory disease of the nerves leading to debilitating weakness in arms and legs, loss of sensation, abnormal sensation and fatigue.
Rationale: Current first-line treatment consists of either intravenous immunoglobulin (IVIg), which is a solution of concentrated antibodies extracted from donor blood, or steroid medications, which have potent anti-inflammatory actions. The choice is based on patient or doctor preference, taking into account pros and cons of each therapy. IVIg treatment leads to faster improvements however it is expensive and it rarely leads to long-term sustained improvement, known as remission. Steroid treatment seems better at achieving long-term remissions but is not as fast in achieving improvements.
Objective: This study aims to determine whether combining IVIg and a steroid treatment called intravenous methylprednisolone (IVMP), leads to more frequent long-term remission than IVIg alone. We will also investigate whether combining IVIg and IVMP results in faster improvement and less healthcare costs.
Study design: This multicentre trial will take place in the Netherlands and United Kingdom. 96 patients with untreated or relapsed CIDP will be randomly allocated to receive treatment either with IVIg and IVMP, or IVIg and placebo (in the form of normal saline). There will be 7 courses of treatment (lasting 1-5 days depending on the dose and tolerability of IVIg), every 3 weeks for 18 weeks, after which each patient will be followed up until 2 years have passed since they entered the study. Patient assessments will include physical examination, questionnaires, monitoring for any adverse effects.
Impact: If our study demonstrates benefits for the combination of IVIg and IVMP, then our protocol will become the new standard of care for initial treatment in CIDP, providing rapid improvement, long-term remission and reduction in CIDP-related healthcare costs.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0094
Date of REC Opinion
1 Apr 2019
REC opinion
Further Information Favourable Opinion