NCT00896168

An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis

A Multi-Center, Pre-Marketing Clinical Trial to Evaluate the Efficacy and Safety of Infliximab Treatment on Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Xian-Janssen Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune disease that causes pain, swelling, stiffness and loss of function in joints) in participants with moderate disease versus participants with severe disease and to compare the efficacy and safety of the MTX subgroups.

Detailed description

This is an open-label (all people know the identity of the intervention), multi-center (study conducted in more than 1 center), prospective (study following participants forward in time) study comparing the American College of Rheumatology (ACR) scores of participants with moderate RA (defined as having a score greater than 3.2, but less than 5.1 on the Disease Activity Score 28 \[DAS 28\]) to those participants with severe RA (defined as having a score greater than 5.1 on the DAS 28 score) disease while being treated with infliximab and MTX. DAS evaluates RA activity by several parameters including the number of swollen and tender joints and the participant's own assessment of their pain. Participants will receive infliximab 3 milligram (mg) per kilogram (kg) intravenous infusion (drug given into a vein) (over no less than 2 hours) at Weeks 0, 2, 6, 14 and 22 along oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 Weeks. Participants will have a follow-up visit on Week 26. Efficacy will primarily be assessed by the percentage of participants obtaining ACR20, ACR50 and ACR70 response at Week 26. Participants' safety will be assessed throughout the study.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Infliximab	Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22.
DRUG	Methotrexate	MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 weeks.

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2009-05-11
• Last updated: 2013-09-13
• Results posted: 2013-09-13