Giant cell arteritis (GCA)
Conditions
Brief summary
Sustained remission at Week 52 as per definition of sustained remission in the protocol.
Detailed description
Time to clinical failure as measured in days through Week 52 per definition of clinical failure in the protocol., Cumulative GC dose through Week 52, Sustained remission at Week 52, Time to clinical failure as measured in days through Week 52, Change in SF-36 score (PCS) at Week 52, Change in Glucocorticoid Toxicity Index (GTI) as measured by the Aggregate Improvement Score (AIS) at Week 52, Change in FACIT-Fatigue score at Week 52, Safety and tolerability demonstrated by assessing: Adverse events (AEs) and serious adverse events (SAEs) (incidence, severity, and relationship to study drug) Changes in laboratory measures and vital signs
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained remission at Week 52 as per definition of sustained remission in the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to clinical failure as measured in days through Week 52 per definition of clinical failure in the protocol., Cumulative GC dose through Week 52, Sustained remission at Week 52, Time to clinical failure as measured in days through Week 52, Change in SF-36 score (PCS) at Week 52, Change in Glucocorticoid Toxicity Index (GTI) as measured by the Aggregate Improvement Score (AIS) at Week 52, Change in FACIT-Fatigue score at Week 52, Safety and tolerability demonstrated by assessing: Adverse events (AEs) and serious adverse events (SAEs) (incidence, severity, and relationship to study drug) Changes in laboratory measures and vital signs | — |
Countries
Austria, Belgium, Bulgaria, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Norway, Poland, Portugal, Spain, Sweden