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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01213017
First Posted: October 1, 2010
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Oklahoma Medical Research Foundation
September 29, 2010
October 1, 2010
December 7, 2017
September 2010
January 2011   (Final data collection date for primary outcome measure)
the change from baseline in synovitis and bone edema RAMRIS score. [ Time Frame: 6 weeks ]
Same as current
Complete list of historical versions of study NCT01213017 on ClinicalTrials.gov Archive Site
the change from baseline in RAMRIS erosion score [ Time Frame: 16 and 52 weeks ]
Same as current
Not Provided
Not Provided
 
The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients
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
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.
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: certolizumab pegol
400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks
Other Name: Cimzia
Experimental: Certolizumab pegol
Intervention: Drug: certolizumab pegol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2012
January 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01213017
OMRF-UCB-5-16-2010
No
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
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available
Oklahoma Medical Research Foundation
Oklahoma Medical Research Foundation
UCB Pharma
Principal Investigator: Ewa Olech, MD Oklahoma Medical Research Foundation
Principal Investigator: Norman B Gaylis, MD Arthritis and Rheumatic Disease Specialties
Oklahoma Medical Research Foundation
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP