Back to results

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

Primary Purpose

Rheumatoid Arthritis, Ultrasonography, Infliximab

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

infliximab

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Perking Union Medical College HospitalRecruiting

Outcomes

Primary Outcome Measures

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 Measures

estimate and visualize the efficacy of treatment with infliximab in RA patients using ultrasonography

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

Full Information

NCT ID

NCT01282528

First Posted

January 24, 2011

Last Updated

January 24, 2011

Sponsor

Peking Union Medical College Hospital

Collaborators

Shanghai Changzheng Hospital, First Hospital of China Medical University, Shenzhen People's Hospital, Changhai Hospital, First Affiliated Hospital of Wenzhou Medical University, First People's Hospital of Foshan, West China Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01282528

Brief Title

Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis

Acronym

ULTRA

Official Title

Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Unknown status

Study Start Date

September 2010 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Peking Union Medical College Hospital

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis, Ultrasonography, Infliximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

85 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

infliximab

Other Intervention Name(s)

Remicade

Intervention Description

3mg/kg, at week 0, 2, 6, 14, 22

Primary Outcome Measure Information:

Title

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.

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

estimate and visualize the efficacy of treatment with infliximab in RA patients using ultrasonography

Time Frame

6, 24 weeks

Title

investigate the validity and sensitivity of ultrasonography assessment of joints inflammation in patients with RA compared with sharp scores

Title

3) observe the relationship between ultrasonography assessment and DAS28, ACR20 and sharp scores and other clinical index

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaomei Leng, MD

Phone

86-13681057089

lengxm@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Zhao, MD

Phone

86-13910188862

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yan Zhao, MD

Organizational Affiliation

Perking Union Medical College hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xiaomei Leng, MD

Organizational Affiliation

Perking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Perking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaomei Leng, MD

Phone

+86-13681057089

lengxm@gmail.com

First Name & Middle Initial & Last Name & Degree

Xiaomei Leng, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

26781785

Citation

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.

Results Reference

derived

Learn more about this trial

Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis

We'll reach out to this number within 24 hrs