Rheumatoid Arthritis Clinical Trial
Official title:
A Two-Part, Phase I Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of MK-8808 and to Compare the Pharmacokinetics of MK-8808 With Rituximab (MabThera™ and Rituxan™) in Patients With Rheumatoid Arthritis (RA)
This is a study of the overall safety, tolerability, and pharmacokinetics (PK) of MK-8808 versus rituximab (MabThera™ and Rituxan™) and in participants with moderate to severe rheumatoid arthritis (RA) concomitantly treated with methotrexate. Participants will be enrolled in two parts and analysis of data from Part A will be performed while Part B is enrolling. Participants will receive one or two courses of therapy, with each course including two infusions of study drugs.
The extension portion of the study (Part C) will sequentially follow the base study beginning at Week 52 and continue for an additional 54 weeks. All participants who meet eligibility criteria and continue into the study extension will be treated with open-label MK-8808. Participants randomized to MK-8808 in the base study will remain on the same therapy. Participants randomized to rituximab (MabThera™ or Rituxan™) in the base study will be switched to MK-8808 for the extension study. ;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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