Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis
Information source: Peking Union Medical College Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis; Ultrasonography; Infliximab
Intervention: infliximab (Biological)
Phase: Phase 4
Status: Recruiting
Sponsored by: Peking Union Medical College Hospital Official(s) and/or principal investigator(s): Yan Zhao, MD, Principal Investigator, Affiliation: Perking Union Medical College hospital Xiaomei Leng, MD, Principal Investigator, Affiliation: Perking Union Medical College Hospital
Overall contact: Xiaomei Leng, MD, Phone: 86-13681057089, Email: lengxm@gmail.com
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.
Clinical Details
Official title: Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: estimate and visualize the efficacy of treatment with infliximab in RA patients using ultrasonographyinvestigate 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
Detailed description:
This is an open-lable, single arm study of the ultrasonographic monitoring of response to
infliximab in patients with rheumatoid arthritis. Approximately 120 subjects will be
enrolled. Subjects will receive infliximab 3mg/kg intravenous infusion at 0, 2, 6 week, and
then repeated every 8 weeks until 24 weeks.
The efficacy assessment is observed by ACR response, HAQ, DAS28, sharp scores and US
assessment at 0,2,6,14, 22, and 24weeks and ultrosonographic and radiographic assessments
are conducted at 0, 6,and 24weeks.
Subjects will be followed for AEs and SAEs up to 8 weeks following the last study treatment
administration (see Section 6).
The end of study is defined as the time the last subject completes the 24 weeks visit.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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.
2. 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).
3. 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.
4. 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.
5. 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.
Exclusion Criteria:
1. Patient who has a known hypersensitivity to human immunoglobulin proteins or other
components of infliximab.
2. Patient who suffers from systemic inflammatory disease whose signs and symptoms are
expected to affect the evaluation of the study drug.
3. Patient who has a history of receiving infliximab or any other biologics.
4. Patient who has stage IV RA.
5. Patient who has had or is on live viral or bacterial vaccinations within 4 weeks to
study entry.
6. 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.
Locations and Contacts
Xiaomei Leng, MD, Phone: 86-13681057089, Email: lengxm@gmail.com
Perking Union Medical College Hospital, Beijing, Beijing 100000, China; Recruiting Xiaomei Leng, MD, Phone: +86-13681057089, Email: lengxm@gmail.com Xiaomei Leng, MD, Principal Investigator
Additional Information
Starting date: September 2010
Last updated: January 24, 2011
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