Rheumatoid ArthritisPhase 4ULTRANCT01282528
Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis
A Phase 4 study testing infliximab in people with Rheumatoid Arthritis and Ultrasonography, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis, Ultrasonography, Infliximab
- What is being tested?
- infliximab
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Yan Zhao, MD contact
China1 site, 1 recruiting
- Recruiting
Perking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Xiaomei Leng, MD, +86-13681057089, lengxm@gmail.com
Xiaomei Leng, MD
About this study
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Ultrasonography, Infliximab
- Being tested
- infliximab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infliximabBiological
Also called Remicade
3mg/kg, at week 0, 2, 6, 14, 22
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (3)
estimate and visualize the efficacy of treatment with infliximab in RA patients using ultrasonography
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Yan Zhao, MD, Principal investigator, Perking Union Medical College hospitalXiaomei Leng, MD, Principal investigator, Perking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282528
- Sponsor's protocol ID
- REMICADEART4011
- Acronym
- ULTRA
- Status last verified
- Jan 2011
- First submitted
- 24 Jan 2011
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26781785
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01282528
- Acronym / sponsor ID
- ULTRA / REMICADEART4011
- Conditions
- Rheumatoid Arthritis, Ultrasonography, Infliximab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- 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
- Study start
- Sep 2010
- First posted
- 25 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infliximabAlso: Remicade3mg/kg, at week 0, 2, 6, 14, 22 | Biological | – |
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.
Time frame: 24 weeks
3 secondary outcomes
estimate and visualize the efficacy of treatment with infliximab in RA patients using ultrasonography
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2011.
- Derived from this study: PubMed 26781785Leng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Zhao, MD contact
Yan Zhao, MD principal investigator
Perking Union Medical College hospital
Xiaomei Leng, MD principal investigator
Perking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing infliximab in people with Rheumatoid Arthritis and Ultrasonography, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaomei Leng, MD (86-13681057089, lengxm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01282528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2011.