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

NCT01213017 | Completed Phase 3 FDA Drug

• 1 other identifier: OMRF-UCB-5-16-2010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Certolizumab pegol; Magnetic Resonance Imaging; Rheumatoid Arthritis; RAPID 3

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (1)

• the change from baseline in RAMRIS erosion score

  16 and 52 weeks

Study Arms (1)

Certolizumab pegol

EXPERIMENTAL

Drug: certolizumab pegol

Interventions

certolizumab pegol DRUG

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

Also known as: Cimzia

Certolizumab pegol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oklahoma Medical Research Foundation: lead
• UCB Pharma: collaborator

Study Sites (2)

Arthritis and Rheumatic Disease Specialties

Aventura, Florida, 33180, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Ewa Olech, MD

  Oklahoma Medical Research Foundation

  PRINCIPAL INVESTIGATOR

• Norman B Gaylis, MD

  Arthritis and Rheumatic Disease Specialties

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: October 1, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: April 1, 2012
• Last Updated: December 7, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)