At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 34 enrolled
Drug / intervention
Rozibafusp Alfa +1 moredrug
Likely dose
Rozibafusp alfa administered by subcutaneous injection once every 2 weeks (specific doses not stated in Phase 1 protocol)AI-extracted
Key inclusion· 5
- ✓Age 18–75 years (inferred from standard Phase 1 criteria; exact age range not stated in published criteria)
- ✓Confirmed rheumatoid arthritis diagnosis for ≥6 months
- ✓Stable methotrexate therapy at 5–25 mg weekly for ≥4 weeks
- ✓BMI 18–35 kg/m²
Key exclusion· 9
- ✕Class IV RA (most severe functional impairment) per ACR criteria
- ✕Malignancy within 5 years
- ✕Serious infection, recurrent, or chronic infections
- ✕Prior rituximab at any time
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double Blind Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of AMG 570 in Subjects With Rheumatoid Arthritis
In Brief
A Phase 1 clinical trial evaluating Rozibafusp Alfa and Placebo for Rheumatoid Arthritis. Completed, enrolled 34 participants across 4 sites in 2 countries.
Detailed Summary
A study to evaluate safety and tolerability and characterize the pharmacokinetic (PK) profile of rozibafusp alfa following multiple dose administration in adults with rheumatoid arthritis (RA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesGermany, United States
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartAug 2017
Primary CompletionOct 2019
Study CompletionJun 2020
TodayJul 2026
First PostedMay 16, 2017
Enrollment StartAug 14, 2017
Primary CompletionOct 17, 2019
Study CompletionJun 12, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.1 years ago
Interventions
Rozibafusp Alfadrug
Administered by subcutaneous injection once every 2 weeks.
Placebodrug
Administered by subcutaneous injection once every 2 weeks.