Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis
ULTRA
1 other identifier
interventional
85
1 country
1
Brief Summary
To evaluate the predictive value of clinical, functional (HAQ), laboratory and US variables in relation to disease activity and radiographic outcome in patients with RA who start treatment with Remicade at 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 24, 2011
CompletedFirst Posted
Study publicly available on registry
January 25, 2011
CompletedJanuary 25, 2011
January 1, 2011
January 24, 2011
January 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
The primary objective of this study is to evaluate the efficacy of treatment with infliximab on synovitis in RA patients using ultrasonography at 24 weeks.
24 weeks
Secondary Outcomes (3)
estimate and visualize the efficacy of treatment with infliximab in RA patients using ultrasonography
6, 24 weeks
investigate the validity and sensitivity of ultrasonography assessment of joints inflammation in patients with RA compared with sharp scores
3) observe the relationship between ultrasonography assessment and DAS28, ACR20 and sharp scores and other clinical index
Interventions
Eligibility Criteria
You may qualify if:
- age 18-65 years, male or female and who are capable of providing informed consent, which must be obtained prior to any study-related procedures.
- Those who have a definitive diagnosis of RA based on the criteria of American College of Rheumatology in 1987 and have moderate to severe disease (DAS28 more than 3.2).
- Patients using oral corticosteroids, must have been on a stable dose of prednisone 10mg/day or its equivalent for at least 4 weeks prior to screening. If currently not using corticosteroids the patient must have not received corticosteroids for at least 4 weeks prior to screening.
- Patients using DMARDs, must have been on a stable dose for at least 12 weeks prior to screening. If currently not using DMARDs the patient must have not received DMARDs for at least 12 weeks prior to screening.
- If using NSAIDs or other analgesics for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent.
You may not qualify if:
- Patient who has a known hypersensitivity to human immunoglobulin proteins or other components of infliximab.
- Patient who suffers from systemic inflammatory disease whose signs and symptoms are expected to affect the evaluation of the study drug.
- Patient who has a history of receiving infliximab or any other biologics.
- Patient who has stage IV RA.
- Patient who has had or is on live viral or bacterial vaccinations within 4 weeks to study entry.
- Patient who ever suffered from chronic or recurrent infection, including but not limited to: chronic kidney infection, chronic thoracic cavity infection (eg. bronchiectasis), nasosinusitis, recurrent urinary tract infection, open, drain or dermal infected wound.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking Union Medical College Hospitallead
- Shanghai Changzheng Hospitalcollaborator
- First Hospital of China Medical Universitycollaborator
- Shenzhen People's Hospitalcollaborator
- Changhai Hospitalcollaborator
- First Affiliated Hospital of Wenzhou Medical Universitycollaborator
- First People's Hospital of Foshancollaborator
- West China Hospitalcollaborator
Study Sites (1)
Perking Union Medical College Hospital
Beijing, Beijing Municipality, 100000, China
Related Publications (1)
Leng X, Xiao W, Xu Z, Zhu X, Liu Y, Zhao D, Xu H, Chen G, Yu W, Lu J, Wang J, Xia X, Li Y, Zhao Y, Tang H, Shi Y, Bao J, Chen L, Lin L, Zhou L, Zhang H, Zhao Y. Ultrasound7 versus ultrasound12 in monitoring the response to infliximab in patients with rheumatoid arthritis. Clin Rheumatol. 2016 Mar;35(3):587-94. doi: 10.1007/s10067-016-3176-2. Epub 2016 Jan 19.
PMID: 26781785DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Zhao, MD
Perking Union Medical College hospital
- PRINCIPAL INVESTIGATOR
Xiaomei Leng, MD
Perking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 24, 2011
First Posted
January 25, 2011
Study Start
September 1, 2010
Last Updated
January 25, 2011
Record last verified: 2011-01