Back to resultsThe Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients (PICS)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
certolizumab pegol
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Certolizumab pegol, Magnetic Resonance Imaging, Rheumatoid Arthritis, RAPID 3
Eligibility 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
Sites / Locations
- Arthritis and Rheumatic Disease Specialties
- Oklahoma Medical Research Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Certolizumab pegol
Arm Description
Outcomes
Primary Outcome Measures
the change from baseline in synovitis and bone edema RAMRIS score.
Secondary Outcome Measures
the change from baseline in RAMRIS erosion score
Full Information
NCT ID
NCT01213017
First Posted
September 29, 2010
Last Updated
December 6, 2017
Sponsor
Oklahoma Medical Research Foundation
Collaborators
UCB Pharma
1. Study Identification
Unique Protocol Identification Number
NCT01213017
Brief Title
The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oklahoma Medical Research Foundation
Collaborators
UCB Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Certolizumab pegol, Magnetic Resonance Imaging, Rheumatoid Arthritis, RAPID 3
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Certolizumab pegol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
certolizumab pegol
Other Intervention Name(s)
Cimzia
Intervention Description
400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks
Primary Outcome Measure Information:
Title
the change from baseline in synovitis and bone edema RAMRIS score.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
the change from baseline in RAMRIS erosion score
Time Frame
16 and 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewa Olech, MD
Organizational Affiliation
Oklahoma Medical Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norman B Gaylis, MD
Organizational Affiliation
Arthritis and Rheumatic Disease Specialties
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthritis and Rheumatic Disease Specialties
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available
Learn more about this trial
The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients
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