NCT07273903: STEPS

Subcutaneous Immunoglobulin Therapy Effectiveness Monitoring in CIDP Patients Using Smart Devices

Recruiting now Last updated 9 March 2026

What this trial tests

trial in CIDP - Chronic Inflammatory Demyelinating Polyneuropathy in 35 participants. Currently enrolling.

Timeline

15 January 2026

Primary endpoint
1 January 2028

1 January 2028

Quick facts

Lead sponsor	Heinrich-Heine University, Duesseldorf
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	35
Start date	15 January 2026
Primary completion	1 January 2028
Estimated completion	1 January 2028
Sites	2 locations across Germany

Conditions studied

• CIDP - Chronic Inflammatory Demyelinating Polyneuropathy — all drugs for CIDP - Chronic Inflammatory Demyelinating Polyneuropathy →

Sponsor

Heinrich-Heine University, Duesseldorf

Who can join

18 and older, any sex, with CIDP - Chronic Inflammatory Demyelinating Polyneuropathy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS)
  Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
  24-item scale, with each item representing a common, daily activity minimum value: 0 points, maximum value: 48 points, best result: 48 points
• Change in Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
  Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
  minimum value: 0 points, maximum value: 10 points, best result: 0 points
• Longitudinal development of activity parameter: step count
  Time frame: 365 days
• Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings
  Time frame: 365 days
  Examples for moderate activity: Walking fast, Cleaning (vacuuming, washing windows, etc.), Playing doubles tennis or badminton, Taking a bike ride, Gardening

Sponsor's own description

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare autoimmune disease that affects the peripheral nerves. It causes progressive weakness and sensory loss in the arms and legs, which can severely limit daily activities. Many patients need long-term treatment with immunoglobulins, either through intravenous infusions (IVIG) or subcutaneous injections (fSCIG).

The S.T.E.P.S. study aims to explore how digital health technologies-specifically smartwatches-can help monitor the disease course and treatment effects in CIDP patients who use fSCIG at home. Current clinical tests are useful but sometimes miss small changes in strength or function. Wearables may provide a more detailed and continuous picture of patients' health between clinic visits.

Study Goals:

The main goal is to find out whether smartwatch data (such as step count and physical activity) reflect disease severity and treatment response when compared to standard clinical scores like the Inflammatory Neuropathy Cause and Treatment (INCAT) scale and the Inflammatory Rasch-built Overall Disability Scale (I-RODS).

Secondary goals include:

Assessing how smartwatch data relate to patients' quality of life and sleep patterns.

Comparing smartwatch results with other clinical scores such as muscle strength (MRC sum score) and grip strength.

Evaluating how well patients can use the smartwatch over the long term during home treatment.

An additional exploratory goal is to see whether smartwatch data can detect early signs of worsening disease before symptoms appear.

Study Design:

This is a 12-month observational study with five main clinic visits (at 0, 3, 6, 9, and 12 months). After enrolling, participants will begin or continue subcutaneous immunoglobulin therapy as decided by their treating physician. Each visit includes standard clinical assessments and questionnaires.

Participants will receive a smartwatch at the start of the study to continuously track their activity and sleep patterns. A follow-up phone call one week later will check that the device is working properly.

Duration:

Recruitment will last about 6 months, and each participant will be followed for 12 months.

Why This Matters:

By combining established clinical measures with continuous digital monitoring, the S.T.E.P.S. study may help improve understanding of disease activity and treatment response in CIDP. This could lead to more personalized therapy schedules and better long-term care for patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.