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: June 30, 2014
Last verified: June 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 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

The inclusion criteria for all patients to be enrolled are:

  • RA by 2010 ACR classification criteria
  • Age ≥ 18 years at enrollment
  • Ability to give consent and follow the study protocol
  • Prednisone permitted in doses ≤10 mg daily
  • Women of reproductive potential must agree to use an acceptable method of birth control during treatment

Additional inclusion criteria for group I:

  • DAS28 ≤ 3.2 during the last 2-months prior to the baseline visit
  • On MTX at a stable dose for > 8 weeks prior to the baseline visit
  • No biologic therapy during the past 6-months prior to the baseline visit
  • No anticipated biologic therapy

Additional inclusion criteria for group II:

  • DAS28 > 3.2
  • No biologic therapy during the past 6-months prior to the baseline visit
  • Scheduled to initiate anti-TNF therapy using CIMZIA

Exclusion Criteria:

  • Any psychiatric disorder that prevents the subject from providing informed consent
  • Inability or unwillingness to follow the protocol
  • Estimated glomerular filtration rate (eGFR, calculated based on serum creatinine) < 60 ml/min/1.72m2
  • Known allergy or hypersensitivity to any study products (including gadolinium)
  • Hip or knee replacement surgery
  • History of injury or surgery of the wrist and hand to be scanned
  • Inability to place non-dominant hand appropriately for imaging
  • History of claustrophobia; inability to tolerate MRI and other contraindication of MRI
  • Pregnancy or breast-feeding
  • Diabetes mellitus requiring insulin therapy
  • Chronic or persistent infection including but not limited to human immunodeficiency virus [HIV], hepatitis B, hepatitis C, listeriosis, TB, or other opportunistic infection)
  • Active infection or severe infections requiring hospitalization or treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to baseline visit, or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to baseline visit
  • Receipt of a live vaccine within 4 weeks prior to baseline visit
  • History of malignancy within the past 5 years other than treated localized carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell skin carcinoma
  • Prednisone dose > 10 mg/day (or equivalent dose of another corticosteroid) within 1 month of baseline visit
  • Any investigational agent within the earlier of 4 weeks or 5 half-lives prior to randomization
  • Any biologic therapy within 6-month prior to the baseline visit
  • Any condition or treatment, which in the opinion of the investigator, places the subject at an unacceptable risk as a participant in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 30, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 30, 2014