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

Oklahoma Medical Research Foundation20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

certolizumab pegolDRUG

400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Arthritis and Rheumatic Disease Specialties

Aventura, Florida, United States

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

the change from baseline in synovitis and bone edema RAMRIS score.

Time frame: 6 weeks

Secondary Outcomes

the change from baseline in RAMRIS erosion score

Time frame: 16 and 52 weeks

Data from ClinicalTrials.gov

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