Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA) — NEXUS  

Rheumatoid Arthritis Clinical Trial

Official title: A 24-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study to Evaluate the Efficacy and Safety of 3 Doses of Namilumab (20 mg, 80 mg and 150 mg) in Combination With Methotrexate (MTX) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)

Status Completed

Clinical Trial Summary

The purpose of this study is to establish proof of concept and identify the optimal efficacious dose for namilumab in RA in patients with an inadequate response to methotrexate (MTX-IR) and in patients with an inadequate response to one tumor necrosis factor (TNF)-inhibitor (TNF-IR).

Clinical Trial Description

The drug being tested in this study is called namilumab. Namilumab is being tested to treat rheumatoid arthritis (RA) in people who have an inadequate response to methotrexate, and in people who have an inadequate response to tumor necrosis factor-inhibitor (TNF-IR). This study will look at improvement in disease activity in participants who take namilumab.

The study will enroll approximately 100 patients. Participants will be randomly assigned (by chance) to one of the four treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

• Namilumab 20 mg/mL subcutaneous injection

• Namilumab 80 mg/mL subcutaneous injection

• Namilumab 150 mg/mL subcutaneous injection

• Placebo (dummy inactive subcutaneous injection) - this is a medication that looks like the study drug but has no active ingredient.

All participants will receive namilumab or placebo as specified in the protocol. A stable dose of methotrexate and daily folic acid will also be required treatments.

This multi-centre trial will be conducted worldwide. The overall time to participate in this study is up to approximately 40 weeks. Participants will make multiple visits to the clinic, including a follow-up assessment up to 18 weeks after the last dose of study medication. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT02379091
• Study type: Interventional
• Source: Takeda
• Status: Completed
• Phase: Phase 2
• Start date: December 17, 2014
• Completion date: December 5, 2016