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

This study has been completed.
Sponsor:
Collaborators:
Arthritis and Rheumatic Disease Specialties
UCB Pharma
Information provided by (Responsible Party):
Ewa Olech, Oklahoma Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT01213017
First received: September 29, 2010
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: certolizumab pegol
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Oklahoma Medical Research Foundation:

Primary Outcome Measures:
  • the change from baseline in synovitis and bone edema RAMRIS score. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the change from baseline in RAMRIS erosion score [ Time Frame: 16 and 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2010
Study Completion Date: April 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Certolizumab pegol Drug: certolizumab pegol
400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks
Other Name: Cimzia

Detailed Description:

The primary objective of this Phase IIIb, two-center, open-label study is to evaluate the efficacy of Certolizumab pegol in reducing synovitis and bone edema by evaluating change from baseline in synovitis and bone edema MRI scores at week 6 in patients with moderate to severe rheumatoid arthritis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213017

Locations
United States, Florida
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Oklahoma Medical Research Foundation
Arthritis and Rheumatic Disease Specialties
UCB Pharma
Investigators
Principal Investigator: Ewa Olech, MD Oklahoma Medical Research Foundation
Principal Investigator: Norman B Gaylis, MD Arthritis and Rheumatic Disease Specialties
  More Information

No publications provided

Responsible Party: Ewa Olech, Assistant Member, Oklahoma Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01213017     History of Changes
Other Study ID Numbers: OMRF-UCB-5-16-2010
Study First Received: September 29, 2010
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Oklahoma Medical Research Foundation:
Certolizumab pegol
Magnetic Resonance Imaging
Rheumatoid Arthritis
RAPID 3

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Certolizumab pegol
Immunoglobulin Fab Fragments
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014