Novel Imaging Markers for Rheumatoid Arthritis

NCT ID: NCT01773681

Last Updated: 2018-11-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2018-03-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Scanco

Eligibility Criteria

Inclusion Criteria

• 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

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)
• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaojuan Li, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF - China Basin Imaging Center

San Francisco, California, United States

Countries

United States

Other Identifiers

UCBCelltech

Identifier Type: -

Identifier Source: org_study_id