Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Conditions
Brief summary
The course of DSQ-SF total score from baseline through follow-up until week 60.
Detailed description
The course of the modified DSQ-SF score from baseline (-12 to 0 weeks) until week 60., The course of SF-36 Physical Function (SF-36 PF), FUNCAP total score and Steps per 24h (calculated as mean values per four-week interval), from baseline (-12 to 0 weeks) until week 60, Overall response, defined as a decrease of 25 points in DSQ-SF score from baseline to the time interval 28 to 48 weeks after start of intervention, Steps per 24 hours, calculated as mean values per four-week interval, from baseline (-12 to 0 weeks) until week 60, Safety and toxicity, recorded continuously through 60 weeks follow-up according to CTCAE ver. 5.0
Interventions
DRUGHyaluronidase 1500 I.U. Powder for Solution for Injection/Infusion
DRUGDARZALEX 1800 mg solution for injection
Sponsors
Helse Bergen HF
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The course of DSQ-SF total score from baseline through follow-up until week 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| The course of the modified DSQ-SF score from baseline (-12 to 0 weeks) until week 60., The course of SF-36 Physical Function (SF-36 PF), FUNCAP total score and Steps per 24h (calculated as mean values per four-week interval), from baseline (-12 to 0 weeks) until week 60, Overall response, defined as a decrease of 25 points in DSQ-SF score from baseline to the time interval 28 to 48 weeks after start of intervention, Steps per 24 hours, calculated as mean values per four-week interval, from baseline (-12 to 0 weeks) until week 60, Safety and toxicity, recorded continuously through 60 weeks follow-up according to CTCAE ver. 5.0 | — |
Countries
Norway
Outcome results
None listed