Novel Imaging Markers for Rheumatoid Arthritis (NIMRA)
|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.|
|ClinicalTrials.gov Identifier: NCT01773681|
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : November 30, 2018
The purpose of this study is to use magnetic resonance imaging (MRI) and high-resolution peripheral quantitative computed tomography (HR-pQCT) techniques to look at the damage and disease activity progression in the hand and wrist joints of patients with rheumatoid arthritis.
The central hypothesis is that ongoing erosions and cartilage loss in rheumatoid arthritis are due to persistent inflammation, which is poorly detected by clinical examination and markers of systemic inflammation.
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis||Drug: Cimzia Device: Magnetic Resonance Imaging (MRI) Device: High-resolution peripheral quantitative computed tomography (HR-pQCT)|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Novel Imaging Markers for Rheumatoid Arthritis|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
- Drug: Cimzia
For the loading phase, it consists of the first 3 doses. During the loading phase, the recommended dose of Cimzia for adults with rheumatoid arthritis is 400mg initially followed by 400mg again at week 2 and week 4. A 400mg dose requires 2 subcutaneous injection of 200mg; the injections should occur at separate sites in the thigh or abdomen.
After the loading dose, will be follow with 200mg every other week. The injection should occur at either the thigh or abdomen.
- Device: Magnetic Resonance Imaging (MRI)
MRI of the dominant wrist, before, during and after the gadolinium contrast injection will be acquired. The dose of the gadolinium agent for this study is 0.1mmol/kg body weight. This gadolinium contrast agent will increase the image contrast in the joints in the wrist and surrounding tissues and will make the MRI pictures stand out better.
- Device: High-resolution peripheral quantitative computed tomography (HR-pQCT)
HR-pQCT scan of the hand and wrist will be acquired to look at the bone quality. The scan uses special x-ray equipment to make detailed pictures of bone structure.Other Name: Scanco
- To better understand how Cimzia and methotrexate affect the damage and disease activity progression in the hand and wrist of patients with rheumatoid arthritis [ Time Frame: up to 2 years ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773681
|United States, California|
|UCSF - China Basin Imaging Center|
|San Francisco, California, United States, 94107|
|Principal Investigator:||Xiaojuan Li, PhD||University of California, San Francisco|