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Efficacy and safety of NNC0114-0006 in active rheumatoid arthritis
2011-005376-42Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2012
- Countries
- 1
- Sponsor
- Novo Nordisk
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Drugs
- NNC0114-0000-0005
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 2, randomised, double-blind trial in rheumatoid arthritis (RA) comparing NNC0114-0006 + methotrexate with Placebo + methotrexate (2 arms). Primary endpoint: Change in DAS28-CRP. Started Mar 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
NNC0114-0006 + methotrexate
Intravenous NNC0114-0006 added to stable background methotrexate therapy in subjects with active rheumatoid arthritis.
Placebo + methotrexate
Intravenous placebo added to stable background methotrexate therapy as control arm.
03
Who it enrols
Adults with a diagnosis of rheumatoid arthritis for at least 6 months meeting ACR classification criteria, on background methotrexate therapy, and with body mass index between 18.0 and 38.0 kg/m^2.
04
Endpoints
Primary
Change in DAS28-CRP
Secondary
ACR20 response
ACR50 response
ACR70 response
Safety and tolerability
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