Phase II Study with MK8457 + MTX in patients with Rheumatoid Arthritis

• Research type

  Research Study

• Full title

  A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy Protocol 008-00

• IRAS ID

  102971

• Contact name

  THOMAS SHEERAN

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

• Eudract number

  2012-000439-17

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Rheumatoid arthritis (RA) affects approximately 1% of the worldwide population and is a chronic, systemic inflammatory disorder characterized by synovial hyperplasia (where the flud in between two joints becomes enlarged), inflammation and irreversible joint destruction. This commonly leads to progressive joint damage, disability and reduction in the quality of life. Current treatment recommendations for RA include early treatment with an oral DMARD (Disease Modifying Antirheumatic Drugs), typically methotrexate (MTX). Other therapies known as biologics are given to patients who do not respond to DMARDs in oral conjunction with MTX in patients who have severe disease. Despite their success, the use of conventional DMARDs and biologics is limited as there are some patients who will not respond, there are also safety concerns and the high cost and pain of continuous injections with biologics limit their use. The development of an oral, effective, and safe DMARD has the potential to dramatically alter the treatment of RA. This is a Phase II, multicenter, double-blind, placebo controlled, parallel group, multicenter worldwide study to assess the safety, tolerability, and efficacy of the study medication in subjects with active RA despite MTX treatment. Subjects must have been treated with MTX for at least 3 months immediately prior to screening. The study has an adaptive design consisting of different periods (Periods 1 and 2) and the treatments will based on interim analysis results: The first part of the study is a Proof of concept study (POC), where the study medication will be assessed to see if it is working or not. Depending on the outcomes of the POC part, the study will move into the dose finding part of the study or the study may be stopped if it meets the criteria set for futility. Once the subjects complete the main part of the study they go into the extension phase where all subjects are on medication. The safety extension will continue for up to 100 weeks. Given the adaptive nature of Phase IIa, there will be approximately 72 up to 434 subjects randomized in the study worldwide.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  12/WM/0142

• Date of REC Opinion

  17 Jul 2012

• REC opinion

  Further Information Favourable Opinion