Novel Imaging Markers for Rheumatoid Arthritis (NIMRA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01773681
First received: January 16, 2013
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: Cimzia
Device: Magnetic Resonance Imaging (MRI)
Device: High-resolution peripheral quantitative computed tomography (HR-pQCT)
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Novel Imaging Markers for Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood sample will be collected and stored at Mary Nakamura's lab at the SF VAMC for future studies.


Estimated Enrollment: 20
Study Start Date: October 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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 non-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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients will be recruited from the UCSF RA Cohort by Drs. John Imboden and Jonathan Graf at SFGH and UCSF Medical Center RA Clinics.

Criteria

Inclusion Criteria:

  • RA by 1987 ACR classification criteria or the 2010 ACR/EULAR classification criteria
  • Age > 18 years
  • Have had RA for 10 years or less
  • Have low disease activity (DAS28 < 3.2)
  • Ability to give consent

Exclusion Criteria:

  • Estimated glomerular filtration rate (eGFR, calculated based on serum creatinine) < 60 ml/min/1.72m2
  • Allergy to gadolinium
  • Hip or knee replacement surgery
  • History of injury or surgery of the wrist and hand to be scanned
  • History of claustrophobia; inability to tolerate MRI
  • Inability to place dominant hand relatively flat for imaging
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773681

Locations
United States, California
UCSF - China Basin Imaging Center
San Francisco, California, United States, 94107
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Xiaojuan Li, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01773681     History of Changes
Other Study ID Numbers: UCBCelltech
Study First Received: January 16, 2013
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014