Clinical trial NCT01773681: Novel Imaging Markers for Rheumatoid Arthritis
Official title: Novel Imaging Markers for Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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 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

Primary outcomes:
measure: To better understand how Cimzia and methotrexate affect the damage and disease activity progression in the hand and wrist of patients with rheumatoid arthritis
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF - China Basin Imaging Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Xiaojuan Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: