Systematic reduction in dosage of subcutanoeus immunoglobulin in patients with chronic inflammatory neuropathy

Randomized, cohort study of standardized reduction of subcutaneous immunoglobulin treatment in patients with chronic inflammatory demyelinating polyneuropathy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002024-24-DK

Enrollment

Registered

2017-06-19

Start date

2017-09-08

Completion date

Unknown

Last updated

2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic inflammatory demyelinating polyneuroapthy MedDRA version: 20.0 Level: LLT Classification code 10077384 Term: Chronic inflammatory demyelinating polyneuropathy System Organ Class: 100000014567

Interventions

Trade Name: Gammanorm Product Name: Gammanorm Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Immunoglobulin Other descriptive name: HUMAN IMMUNOGLOBULIN G Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosed with CIDP Treated with subcutaneous immunoglobulin in unaltered dosage for at least 3 months Age > 18 years 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Other forms of neuropathy or myopathy treated with SCIG Age < 18 years Pregnancy or breast feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To identify the lowest effective dosage of subcutaneous immunoglobulin in maintenance treatment of CIDP;Secondary Objective: Not applicable;Primary end point(s): Change in overall disability sum score (ODSS);Timepoint(s) of evaluation of this end point: Evaluation every 3rd month, where dose of SCIG is reduced further if no deterioration occur	—

Secondary

Measure	Time frame
Secondary end point(s): Changes in muscle strength (MRC, isokinetic muscle strength, grip strength) Changes in sensory modality (INCAT SSS) Changes in disability (9-hole-peg-test, six-spot-step-test, 10-meter-walk-test) Changes in quality of life, fatigue and pain (RODS, EQ-5D-5L, FSS, NPSI) ;Timepoint(s) of evaluation of this end point: Same as for primary endpoint	—

Countries

Denmark

Contacts

Public ContactLars Markvardsen

Aarhus University Hospital

larsmark@rm.dk004578463337

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026