Takayasu ArteritisPhase 2/3ATITANCT03550781
Anti-inflammatory Treatment for Inactive Takayasu Arteritis
A Phase 2/3 study testing Prednisone, cyclophosphamide in people with Takayasu Arteritis and Anti-Inflammatory Agents, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
Trial summary
Currently, the traditional disease activity of Takayasu arteritis is mainly based on National Institutes of Health criteria and the inactive cases don't need anti-inflammatory treatment. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Takayasu Arteritis, Anti-Inflammatory Agents
- What is being tested?
- Prednisone, cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to 31 May 2021
- Phase
- Phase 2/3
- 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 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Takayasu arteritis diagnosed by the American College of Rheumatology 1990 criteria;
- Inactive Takayasu arteritis according to National Institutes of Health criteria;
- Age ≥ 14 and ≤ 40 years old at the time of informed consent;
- Patients or guardian agree to participate in the study.
Who cannot join
- Active Takayasu arteritis according to National Institutes of Health criteria;
- Poor compliance, intolerance to or poor response to hormone therapy;
- Allergy to contrast agent;
- Renal insufficiency (serum creatinine >133μmol/L), cardiac insufficiency (NYHA functional class III and IV) or abnormal liver function (Alanine transaminase >1.5 times upper limit of normal)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does Inactive Takayasu Arteritis(NIH Criteria) Need Anti-inflammatory Treatment？
Currently, the traditional disease activity of Takayasu arteritis is mainly based on National Institutes of Health criteria and the inactive cases don't need anti-inflammatory treatment. However, pathologic findings showed that there was still inflammatory activity in the affected vessels, and the follow-up data also found significant lesion progression in some inactive cases. Sixty inactive Takayasu arteritis patients will be recruited to determine whether these individuals are active by screening new inflammatory markers in this study. New inflammatory markers included tumor necrosis factor,interleukin-2,interleukin-6,interleukin-8,interleukin-10,high-sensitivity C-reactive protein, and 18f-FDG positron emission tomograph. According to new inflammatory markers, sixty patients will be divided into two categories: inactive patients (n=20) and active patients (n=40). And then, Forty active patients diagnosed by new inflammatory markers will be randomly assigned to either anti-inflammatory therapy group or control group. The changes of inflammatory activity and lesion progression will be observed during one-year follow up in all 60 patients.
- Conditions
- Takayasu Arteritis, Anti-Inflammatory Agents
- Being tested
- Prednisone, cyclophosphamide
- Keywords
- Takayasu Arteritis, Anti-Inflammatory Agents, Positron Emission Tomography Computed Tomography
- Medical subject headings
- Takayasu Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone, cyclophosphamideDrug
Prednisone 0.5mg/(kg•d) and/or cyclophosphamide 2mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Anti-inflammatory treatment group | Experimental | Prednisone and/or cyclophosphamide Receives: Drug: Prednisone, cyclophosphamide |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion progression
Progression of previous lesion degree>20% or new lesion
Measured: baseline and 12 months
Secondary outcomes (8)
Lesion progression
Progression of previous lesion degree>20% or new lesion
Measured: baseline, 3 months, 6 months, 9 months
Changes in plasma concentration of tumor necrosis factor
Measured: baseline, 3 months, 6 months, 9 months and 12 months
Changes in plasma concentration of interleukin-2
Measured: baseline, 3 months, 6 months, 9 months and 12 months
Changes in plasma concentration of interleukin-6
Measured: baseline, 3 months, 6 months, 9 months and 12 months
Changes in plasma concentration of interleukin-8
Measured: baseline, 3 months, 6 months, 9 months and 12 months
Changes in plasma concentration of interleukin-10
Measured: baseline, 3 months, 6 months, 9 months and 12 months
Changes in plasma concentration of high-sensitivity C-reactive protein
Measured: baseline, 3 months, 6 months, 9 months and 12 months
Changes in 18F-fluorodeoxyglucose uptake by positron emission tomograph
Measured: baseline, 3 months, 6 months, 9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Jun 2018 (estimated)
- Primary completion31 May 2020 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takayasu ArteritisStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xiongjing Jiang, MD, Principal investigator, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550781
- Sponsor's protocol ID
- 2018-992
- Acronym
- ATITA
- Status last verified
- Jun 2018
- First submitted
- 5 May 2018
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Inactive Takayasu Arteritis(NIH Criteria) Need Anti-inflammatory Treatment？
- ClinicalTrials.gov ID
- NCT03550781
- Acronym / sponsor ID
- ATITA / 2018-992
- Conditions
- Takayasu Arteritis, Anti-Inflammatory Agents
- Keywords
- Takayasu Arteritis, Anti-Inflammatory Agents, Positron Emission Tomography Computed Tomography
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 8 Jun 2018 (actual)
- 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.
Currently, the traditional disease activity of Takayasu arteritis is mainly based on National Institutes of Health criteria and the inactive cases don't need anti-inflammatory treatment. However, pathologic findings showed that there was still inflammatory activity in the affected vessels, and the follow-up data also found significant lesion progression in some inactive cases. Sixty inactive Takayasu arteritis patients will be recruited to determine whether these individuals are active by screening new inflammatory markers in this study. New inflammatory markers included tumor necrosis factor,interleukin-2,interleukin-6,interleukin-8,interleukin-10,high-sensitivity C-reactive protein, and 18f-FDG positron emission tomograph. According to new inflammatory markers, sixty patients will be divided into two categories: inactive patients (n=20) and active patients (n=40). And then, Forty active patients diagnosed by new inflammatory markers will be randomly assigned to either anti-inflammatory therapy group or control group. The changes of inflammatory activity and lesion progression will be observed during one-year follow up in all 60 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-inflammatory treatment group | Experimental | Drug: Prednisone, cyclophosphamidePrednisone and/or cyclophosphamide |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Takayasu arteritis diagnosed by the American College of Rheumatology 1990 criteria;
- Inactive Takayasu arteritis according to National Institutes of Health criteria;
- Age ≥ 14 and ≤ 40 years old at the time of informed consent;
- Patients or guardian agree to participate in the study.
Key exclusion criteria (4 listed)
- Active Takayasu arteritis according to National Institutes of Health criteria;
- Poor compliance, intolerance to or poor response to hormone therapy;
- Allergy to contrast agent;
- Renal insufficiency (serum creatinine >133μmol/L), cardiac insufficiency (NYHA functional class III and IV) or abnormal liver function (Alanine transaminase >1.5 times upper limit of normal)
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 |
|---|---|---|
| Prednisone, cyclophosphamidePrednisone 0.5mg/(kg•d) and/or cyclophosphamide 2mg/kg | Drug | Anti-inflammatory treatment group |
Primary outcome
Lesion progression
Time frame: baseline and 12 months
Progression of previous lesion degree>20% or new lesion
8 secondary outcomes
Lesion progression
Time frame: baseline, 3 months, 6 months, 9 months
Changes in plasma concentration of tumor necrosis factor
Time frame: baseline, 3 months, 6 months, 9 months and 12 months
Changes in plasma concentration of interleukin-2
Time frame: baseline, 3 months, 6 months, 9 months and 12 months
Changes in plasma concentration of interleukin-6
Time frame: baseline, 3 months, 6 months, 9 months and 12 months
Changes in plasma concentration of interleukin-8
Time frame: baseline, 3 months, 6 months, 9 months and 12 months
Changes in plasma concentration of interleukin-10
Time frame: baseline, 3 months, 6 months, 9 months and 12 months
Changes in plasma concentration of high-sensitivity C-reactive protein
Time frame: baseline, 3 months, 6 months, 9 months and 12 months
Changes in 18F-fluorodeoxyglucose uptake by positron emission tomograph
Time frame: baseline, 3 months, 6 months, 9 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
Xiongjing Jiang, MD principal investigator
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Prednisone, cyclophosphamide in people with Takayasu Arteritis and Anti-Inflammatory Agents, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
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 4 inclusion and 4 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 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xiongjing Jiang, MD (86-1088322385, jxj103@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion progression (time frame: baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2018.