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

Rheumatoid Arthritis Clinical Trial

— PICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213017
• Other study ID #: OMRF-UCB-5-16-2010
• Status: Completed
• Phase: Phase 3
• First received: September 29, 2010
• Last updated: December 6, 2017
• Start date: September 2010
• Est. completion date: April 2012

Study information

• Verified date: December 2017
• Source: Oklahoma Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• moderate to severe RA (DAS > 4.4)

• at least two swollen and tender joints in one of the hand/ wrist

• patients must have failed at least one non-biologic or biologic DMARDs

• currently receiving MTX therapy

Exclusion Criteria:

• concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Synovitis

Intervention

Drug:
• certolizumab pegol
400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks

Locations

Country	Name	City	State
United States	Arthritis and Rheumatic Disease Specialties	Aventura	Florida
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Oklahoma Medical Research Foundation	UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change from baseline in synovitis and bone edema RAMRIS score.		6 weeks
Secondary	the change from baseline in RAMRIS erosion score		16 and 52 weeks