The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients (PICS)
This study has been completed.
Sponsor:
Oklahoma Medical Research Foundation
Collaborators:
Arthritis and Rheumatic Disease Specialties
UCB, Inc.
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
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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
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, Inc.
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 Synovitis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Immunoglobulin Fab Fragments Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013