MK-8808 in patients with Rheumatoid Arthritis
Research type
Research Study
Full title
A Two-Part, Phase I Randomised, 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)
IRAS ID
78490
Contact name
Adewale Adebajo
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2011-000387-98
Clinicaltrials.gov Identifier
Research summary
Rheumatoid arthritis (RA) is a systemic chronic, inflammatory disorder characterised by affection of synovial joints (e.g knee or wrist) but may affect also other non-joint organs (lungs, eyes, etc). About 1% of the world's population is affected by rheumatoid arthritis. It can be a disabling and painful condition, which can lead to substantial loss of functioning and mobility. This research study aims to test MK 8808, a new drug that has not been approved for sale. MK-8808 is considered a biosmilar drug - a similar version of an already approved biological medicinal product made by a different company. In this case the approved reference drug is rituximab which is used for the treatment of Rheumatoid Arthritis in conjunction with another licensed drug, methotrexate. The purpose of this study is to: ?½ Test the safety of the study drug, MK-8808. ?½ Measure the amount of MK-8808 and rituximab in the blood after dosing. ?½ Assess the effect of MK-8808 and rituximab on blood cells targeted by MK-8808. ?½ Assess MK-8808 and rituximab as treatments for RA. ?½ Assess how MK-8808 and rituximab can affect quality of life in RA patients. ?½ Assess the body??s immune response to MK-8808 and rituximab. The study is divided into two parts with patients being involved in either part A or part B not both. Patients will be assigned by chance (like the flip of a coin) to one of the groups below. Part A: Treatment 1: MK-8808 administered on Day 1 and Day 15 Treatment 2: Rituximab (MabThera) administered on Day 1 and Day 15 Part B: Treatment 1: MK-8808 administered on Day 1 and Day 15 Treatment 2: Rituximab (MabThera) administered on Day 1 and Day 15 Treatment 3: Rituximab (Rituxan) administered on Day 1 and Day 15. Participating patients will receive one or two treatment courses (two doses per treatment course) of study drug and return to the study site on multiple occasions after treatment for study assessments. Since the part A enrolment of the study has already been completed, the UK will only be participating in Part B only. About 234 people will be enrolled into in part B of the study. This study (part A and B) is the first study that is investigating MK-8808 in humans.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
12/YH/0365
Date of REC Opinion
10 Oct 2012
REC opinion
Further Information Favourable Opinion