Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis

Albert Christian Ludolph, Prof.

Status: Completed

Conditions: Multiple Sclerosis; Clinically Isolated Syndrome

Treatments: Procedure: Plasmapheresis; Procedure: Immunoadsorption

Study type: Interventional

Funder types: Other

Identifiers

NCT02671682

IAPEMS

Details and patient eligibility

About

This observational study investigates the efficacy and safety of immunoadsorption versus plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated syndrome who do not fully recover after a high doses of intravenous corticosteroids.

Enrollment: 61 patients

Sex: All

Ages: 12 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• relapse of Multiple Sclerosis or Clinically Isolated Syndrome (without complete remission after high dose steroid therapy)
• informed consent
• age ≥ 12 years old

Exclusion criteria

• clinical or laboratory signs of infection
• intake of Angiotensin Converting Enzyme Inhibitor within 1 week prior to first treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Immunoadsorption

Experimental group

Description:

Immunoadsorption on 5 consecutive days with protein A columns and 2,5-fold patient's plasma volume

Treatment:

Procedure: Immunoadsorption

Plasmapheresis

Active Comparator group

Description:

Plasmapheresis on 5 consecutive days with 2l plasma exchange

Treatment:

Procedure: Plasmapheresis