drugset
drugset / Trial / NCT01390441

A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002)

NCT01390441 ↗

Phase 1 Terminated 100 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a study of the overall safety, tolerability, and pharmacokinetics (PK) of MK-8808 versus rituximab (MabThera® and Rituxan®) in participants with moderate to severe RA with an inadequate response or intolerance to methotrexate.

Timeline

Start
2011-07
Primary completion
2014-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-8808 Unknown 500 mg/m2 Intravenous
Subject MK-8808 Unknown 1000 mg Intravenous
Comparator Rituximab Monoclonal antibody 500 mg/m2 Intravenous
Comparator Rituximab Monoclonal antibody 1000 mg Intravenous
Background Acetaminophen Small molecule 1000 mg Oral
Background Acetaminophen Small molecule 1350 mg Oral
Background Loratadine Small molecule 10 mg Oral
Background Methotrexate Small molecule 10 mg Oral
Background Methotrexate Small molecule 25 mg Oral
Background Methylprednisolone Other / unclassified 100 mg Intravenous

Indications

rheumatoid arthritis