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MK-8457 in RA with Inadequate Response to Anti-TNF
NCT01651936Phase 2
Key facts
- Status
- Terminated
- Start
- Aug 2012
- Primary completion
- Oct 2013
- Sponsor
- Merck & Co.
- Modality
- Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands
- Drugs
- MK-8457
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 2, randomised, double-blind trial of MK-8457 in rheumatoid arthritis (RA) (3 arms), sponsored by Merck & Co. Primary endpoint: Change From Baseline in Disease Activity Score 28 C-Reactive Protein at 12 weeks. Started Aug 2012; status: terminated.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Base Study: MK-8457
MK-8457 100 mg BID + MTX
Base Study: Placebo
Placebo BID + MTX
Safety Extension: MK-8457
Open-label MK-8457 100 mg BID + MTX
03
Who it enrols
Adults with active rheumatoid arthritis for at least 6 months who have had an inadequate response or intolerance to 1 or 2 anti-TNF therapies and are on a stable dose of methotrexate.
04
Endpoints
Primary
Change From Baseline in Disease Activity Score 28 C-Reactive Protein
Secondary
Percentage of Participants Achieving an ACR20 Response
Percentage of Participants Achieving an ACR50 Response
Change From Baseline in Disease Activity Score 28 C-Reactive Protein
Change From Baseline in Health Assessment Questionnaire Disability Index
05
Results
Not all primary endpoints met
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