Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Conditions
Brief summary
Period 2 / Cohort A: Proportion of participants who remain relapse-free at Week 36 where relapse is defined as a worsening (increase) of ≥ 1 point on the Adj INCAT score at any time point during Period 2 relative to Period 2 baseline which is sustained at a Follow-Up visit 1 week later.
Detailed description
Period 2 / Cohort A: -Time to first relapse relative to Period 2 baseline - Change from Period 2 baseline to Week 36 in: Adj INCAT score, Inflammatory Rasch-built Overall Disability Scale (I-RODS), Mean Grip Strength, Medical Research Council (MRC) Sum Score, Overall Neuropathy Limitations Scale (ONLS), Period 2 / Cohort A and B combined: Change from Period 2 baseline to Week 36 in: Adj INCAT score, I-RODS, Mean Grip Strength, MRC Sum Score, ONLS, Period 2 / Cohorts A, B and C combined: Proportion of participants who remain relapse-free at Week 36.
Interventions
Sponsors
Immunovant Sciences GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Period 2 / Cohort A: Proportion of participants who remain relapse-free at Week 36 where relapse is defined as a worsening (increase) of ≥ 1 point on the Adj INCAT score at any time point during Period 2 relative to Period 2 baseline which is sustained at a Follow-Up visit 1 week later. | — |
Secondary
| Measure | Time frame |
|---|---|
| Period 2 / Cohort A: -Time to first relapse relative to Period 2 baseline - Change from Period 2 baseline to Week 36 in: Adj INCAT score, Inflammatory Rasch-built Overall Disability Scale (I-RODS), Mean Grip Strength, Medical Research Council (MRC) Sum Score, Overall Neuropathy Limitations Scale (ONLS), Period 2 / Cohort A and B combined: Change from Period 2 baseline to Week 36 in: Adj INCAT score, I-RODS, Mean Grip Strength, MRC Sum Score, ONLS, Period 2 / Cohorts A, B and C combined: Proportion of participants who remain relapse-free at Week 36. | — |
Countries
Belgium, Bulgaria, Denmark, Finland, Germany, Greece, Italy, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden
Outcome results
None listed