Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis (ULTRA)

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis; Ultrasonography; Infliximab
• Intervention / Treatment: Biological: infliximab

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.

• Study Type: Interventional
• Enrollment (Anticipated): 85
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Perking Union Medical College Hospital
      • Contact: Xiaomei Leng, MD; Phone Number: +86-13681057089; Email: lengxm@gmail.com
      • Principal Investigator: Xiaomei Leng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Changhai Hospital; West China Hospital; Shenzhen People's Hospital; First People's Hospital of Foshan; First Hospital of China Medical University; First Affiliated Hospital of Wenzhou Medical University; Shanghai Changzheng Hospital
• Investigators: Principal Investigator: Yan Zhao, MD, Perking Union Medical College Hospital; Principal Investigator: Xiaomei Leng, MD, Perking Union Medical College Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010

Study Registration Dates

• First Submitted: January 24, 2011
• First Submitted That Met QC Criteria: January 24, 2011
• First Posted (Estimate): January 25, 2011

Study Record Updates

• Last Update Posted (Estimate): January 25, 2011
• Last Update Submitted That Met QC Criteria: January 24, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: REMICADEART4011