Intravenous immunoglobulin overtreatment in chronic inflammatory demyelinating polyneuropathy

Intravenous immunoglobulin overtreatment in chronic inflammatory demyelinating polyneuropathy: a randomized controlled non-inferiority trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13637698

Enrollment

Registered

2014-03-25

Start date

2014-04-01

Completion date

Unknown

Last updated

2022-11-14

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

Conditions

Chronic inflammatory demyelinating polyneuropathy (CIDP) Nervous System Diseases Inflammatory polyneuropathy

Interventions

Subjects will be randomised to one of the following two treatments: 1. IVIg withdrawal (tapering consists of three infusions (75%, 50% and 25% respectively of the subjects? pre-study I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Probable or definite CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010 2. Stable disease for 6 months (i.e., no progression of disease in the last 6 months) 3. IVIg treatment for at least 6 months 4. IVIg infusion interval of 2 to 6 weeks 5. Age > 18 years

Exclusion criteria

Exclusion criteria: 1. Deterioration after IVIg withdrawal in the last 12 months 2. Changes in IVIg treatment dose/interval in last 6 months 3. Change of additional CIDP treatment, if any, in the last 3 months (e.g., corticosteroids or immunosuppressive treatment) 4. A prolonged period (> 6 weeks) of disability increase following an earlier IVIg withdrawal attempt 5. History of respiratory failure related to CIDP 6. Legally incompetent 7. Lack of written informed consent

Design outcomes

Primary

Measure	Time frame
The change between baseline and endpoint Rasch-Overall Disability Score (R-ODS). An endpoint will be reached in case of one of the following: final visit at 24 weeks or deterioration on the R-ODS by more than 0.652 logits during follow-up.	—

Secondary

Measure	Time frame
1. The proportion of subjects remaining stable on their individual R-ODS score and completing the follow-up period. An individual subject will be considered stable if the difference between his or her baseline and endpoint R-ODS scores is less than 0.652 logits. 2. Muscle strength using the Medical Research Council (MRC) sum score of 12 predefined muscle groups (range 0 to 60, including shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension and foot dorsiflexion). 3. Grip strength, measured in kPa by a Martin vigorimeter. 4. Sensory impairment using the modified INCAT Sensory Sum Score (INCAT?SS, range 0-20). 5. Subject?s perception of clinical deterioration on a 5-point Likert scale. 6. Disease-non-specific disability using the AMC Linear Disability Scale (ALDS, range 0 [dead] to 100 [fully able]). 7. Quality of life using Short Form-36 (SF-36). 8. Pain using the Pain-Intensity Numerical Rating Scale (PI-NRS, an 11-point scale). 9. Fatigue using a 7-item linear modified Rasch-built fatigue scale. 10. Costs of healthcare use, costs of production loss, and out-of-pocket expenses. 11. Difference between serum IgG levels before and after last IVIg infusion prior to first study treatment All secondary outcomes will be measured when an endpoint is reached. An endpoint will be reached in case of one of the following: 1. Final visit at 24 weeks 2. Deterioration on the R-ODS by more than 0.652 logits during follow-up	—

Measure

Time frame

1. The proportion of subjects remaining stable on their individual R-ODS score and completing the follow-up period. An individual subject will be considered stable if the difference between his or her baseline and endpoint R-ODS scores is less than 0.652 logits. 2. Muscle strength using the Medical Research Council (MRC) sum score of 12 predefined muscle groups (range 0 to 60, including shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension and foot dorsiflexion). 3. Grip strength, measured in kPa by a Martin vigorimeter. 4. Sensory impairment using the modified INCAT Sensory Sum Score (INCAT?SS, range 0-20). 5. Subject?s perception of clinical deterioration on a 5-point Likert scale. 6. Disease-non-specific disability using the AMC Linear Disability Scale (ALDS, range 0 [dead] to 100 [fully able]). 7. Quality of life using Short Form-36 (SF-36). 8. Pain using the Pain-Intensity Numerical Rating Scale (PI-NRS, an 11-point scale). 9. Fatigue using a 7-item linear modified Rasch-built fatigue scale. 10. Costs of healthcare use, costs of production loss, and out-of-pocket expenses. 11. Difference between serum IgG levels before and after last IVIg infusion prior to first study treatment All secondary outcomes will be measured when an endpoint is reached. An endpoint will be reached in case of one of the following: 1. Final visit at 24 weeks 2. Deterioration on the R-ODS by more than 0.652 logits during follow-up

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026