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RPH-104 in Acute Gout Attack
NCT04067492Phase 2
Key facts
- Status
- Terminated
- Start
- Mar 2018
- Primary completion
- Mar 2020
- Countries
- 1
- Sponsor
- R-Pharm
- Modality
- Fc-Fusion Proteins
- Drugs
- goflikicept
- Conditions
- gout
01
Overview
Phase 2, randomised, open-label trial of goflikicept in gout (6 arms), sponsored by R-Pharm. Primary endpoint: Change in Pain Intensity in the Assessed Joint at 72 hours. Started Mar 2018; status: terminated.
02
Design
6 arms- Study design
- RandomizedOpen-label
RPH - 4 mg
Goflikicept 4 mg single dose
RPH - 20 mg
Goflikicept 20 mg single dose
RPH - 40 mg
Goflikicept 40 mg single dose
RPH - 80 mg
Goflikicept 80 mg single dose
RPH - 160 mg
Goflikicept 160 mg single dose
Voltaren (diclofenac)
Diclofenac oral taper over 12 days
03
Who it enrols
Adult patients with an established diagnosis of gout and a current acute gout attack (pain VAS 50-100 mm, onset < 120 hours) who are eligible for NSAID therapy.
04
Endpoints
Primary
Change in Pain Intensity in the Assessed Joint
Secondary
Change in Pain Intensity in the Assessed Joint over time
Proportion of Patients Who Assessed the Response to Therapy as 'Excellent' or 'Good'
Change in the Rate of Swelling of the Assessed Joint
Change in the Rate of Tenderness of the Assessed Joint
Change in the Rate of Erythema of the Assessed Joint
Change in the Rate of Movement Restrictions
Time to Achieve the 50% Decrease in Pain Intensity
Proportion of Patients Who Received a Rescue Therapy Agent
05
Results
Not all primary endpoints met
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