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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:
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

September 29, 2010
March 7, 2013
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01213017
OMRF-UCB-5-16-2010
No
Ewa Olech, Oklahoma Medical Research Foundation
Oklahoma Medical Research Foundation
  • Arthritis and Rheumatic Disease Specialties
  • 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
March 2013

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