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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Peking Union Medical College Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Shanghai Changzheng Hospital
China Medical University, China
Shenzhen People's Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Wenzhou Medical University
First People's Hospital of Foshan
West China Hospital
Information provided by:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01282528
First received: January 24, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Ultrasonography
Infliximab
Biological: infliximab
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • estimate and visualize the efficacy of treatment with infliximab in RA patients using ultrasonography [ Time Frame: 6, 24 weeks ] [ Designated as safety issue: No ]
  • investigate the validity and sensitivity of ultrasonography assessment of joints inflammation in patients with RA compared with sharp scores [ Designated as safety issue: No ]
  • 3) observe the relationship between ultrasonography assessment and DAS28, ACR20 and sharp scores and other clinical index [ Designated as safety issue: No ]

Estimated Enrollment: 85
Study Start Date: September 2010
Intervention Details:
    Biological: infliximab
    3mg/kg, at week 0, 2, 6, 14, 22
    Other Name: Remicade
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282528

Contacts
Contact: Xiaomei Leng, MD 86-13681057089 lengxm@gmail.com
Contact: Yan Zhao, MD 86-13910188862

Locations
China, Beijing
Perking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Xiaomei Leng, MD    +86-13681057089    lengxm@gmail.com   
Principal Investigator: Xiaomei Leng, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital
Shanghai Changzheng Hospital
China Medical University, China
Shenzhen People's Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Wenzhou Medical University
First People's Hospital of Foshan
West China Hospital
Investigators
Principal Investigator: Yan Zhao, MD Perking Union Medical College hospital
Principal Investigator: Xiaomei Leng, MD Perking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Yan Zhao, Xiaomei Leng, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01282528     History of Changes
Other Study ID Numbers: REMICADEART4011
Study First Received: January 24, 2011
Last Updated: January 24, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014