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

NCT01390441 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-07-20

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

MK-8808

MK-8808 500 mg/m\^2 administered by IV on Day 1 and Day 15 or MK-8808 1000 mg administered by IV at Week 54 and Week 56

BIOLOGICAL

MabThera® (rituximab)

MabThera® 500 mg/m\^2 or 1000 mg administered by IV on Day 1 and Day 15

DRUG

Methotrexate

Methotrexate 10-25 mg administered orally, SC, or IM as a weekly stable dose

BIOLOGICAL

Rituxan® (rituximab)

Rituxan® 1000 mg administered by IV on Day 1 and Day 15

DRUG

Methylprednisolone

Methylprednisolone 100 mg administered IV before initiation of each infusion as pre-medication to reduce the incidence and severity of infusion reactions

DRUG

Acetaminophen

Acetaminophen 1000 to 1350 mg administered orally before initiation of each infusion as pre-medication to reduce the incidence and severity of infusion reactions

DRUG

Loratadine

Loratidine 10 mg administered orally before initiation of each infusion as pre-medication to reduce the incidence and severity of infusion reactions

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-04-30
Completion
2014-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01390441 on ClinicalTrials.gov