NCT01213017

The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients

The Effect of Certolizumab Pegol in Combination With Methotrexate on MRI Synovitis and Bone Edema and Patient Reported Outcomes as Measured Using an Automated Visit Manager System in Moderate to Severe Rheumatoid Arthritis Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Oklahoma Medical Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Certolizumab pegol can rapidly reduce the inflammatory changes and inhibit erosions on hand and wrist MRI in patients with active moderate to severe rheumatoid arthritis.

Detailed description

The primary objective of this study is to evaluate the efficacy of CSP used in combination with MTX in patients with active moderate to severe RA by evaluating change from baseline in synovitis and bone edema MRI scores at week 6.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	certolizumab pegol	400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-01-01
• Completion: 2012-04-01
• First posted: 2010-10-01
• Last updated: 2017-12-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study