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

Oklahoma Medical Research Foundation

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: certolizumab pegol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01213017

OMRF-UCB-5-16-2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Certolizumab pegol

Experimental group

Treatment:

Drug: certolizumab pegol