Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Conditions
Brief summary
Safety and tolerability as measured by treatment-emergent adverse events.
Detailed description
Changes in SF36 domain scores including Physical Function and Bodily pain, from the baseline/run-in period through 40 weeks' follow-up from start of intervention, Changes in DSQ-SF scores, from the baseline/run-in period through 40 weeks' follow-up from start of intervention, Changes in patient-reported physical function, from the baseline/run-in period through 40 weeks' follow-up from start of intervention, Changes in steps per 24 hours, from the baseline/run-in period through 40 weeks' follow-up from start of intervention
Interventions
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 |
|---|---|
| Safety and tolerability as measured by treatment-emergent adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in SF36 domain scores including Physical Function and Bodily pain, from the baseline/run-in period through 40 weeks' follow-up from start of intervention, Changes in DSQ-SF scores, from the baseline/run-in period through 40 weeks' follow-up from start of intervention, Changes in patient-reported physical function, from the baseline/run-in period through 40 weeks' follow-up from start of intervention, Changes in steps per 24 hours, from the baseline/run-in period through 40 weeks' follow-up from start of intervention | — |
Countries
Norway
Outcome results
None listed