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
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 29, 2010 | ||||||||
| Last Updated Date | March 7, 2013 | ||||||||
| Start Date ICMJE | September 2010 | ||||||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
the change from baseline in synovitis and bone edema RAMRIS score. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01213017 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
the change from baseline in RAMRIS erosion score [ Time Frame: 16 and 52 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Rheumatoid Arthritis | ||||||||
| Intervention ICMJE | Drug: certolizumab pegol
400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks
Other Name: Cimzia |
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| Study Arm (s) | Experimental: Certolizumab pegol
Intervention: Drug: certolizumab pegol |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 20 | ||||||||
| Completion Date | April 2012 | ||||||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01213017 | ||||||||
| Other Study ID Numbers ICMJE | OMRF-UCB-5-16-2010 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Ewa Olech, Oklahoma Medical Research Foundation | ||||||||
| Study Sponsor ICMJE | Oklahoma Medical Research Foundation | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Oklahoma Medical Research Foundation | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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