Novel Imaging Markers for Rheumatoid Arthritis (NIMRA)

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Cimzia; Device: Magnetic Resonance Imaging (MRI); Device: High-resolution peripheral quantitative computed tomography (HR-pQCT)

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • UCSF - China Basin Imaging Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 for all patients to be enrolled are:

• 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)
• 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
• 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

Additional exclusion criteria for Group II:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To better understand how Cimzia and methotrexate affect the damage and disease activity progression in the hand and wrist of patients with rheumatoid arthritis	up to 2 years

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Xiaojuan Li, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: January 16, 2013
• First Submitted That Met QC Criteria: January 18, 2013
• First Posted (Estimate): January 23, 2013

Study Record Updates

• Last Update Posted (Actual): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 29, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Certolizumab Pegol
• Other Study ID Numbers: UCBCelltech

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No