Novel Imaging Markers for Rheumatoid Arthritis

NCT01773681 | Completed FDA Drug

• 1 other identifier: UCBCelltech
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Cimzia DRUG

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.

Magnetic Resonance Imaging (MRI) DEVICE

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.

High-resolution peripheral quantitative computed tomography (HR-pQCT) DEVICE

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.

Also known as: Scanco

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF - China Basin Imaging Center

San Francisco, California, 94107, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab Pegol; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Xiaojuan Li, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 23, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

US (1)