Takayasu ArteritisPhase 4ADATOFTAKNCT05151848
Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
A Phase 4 study testing Adalimumab Injection and Tofacitinib 5 MG in people with Takayasu Arteritis, run by Chinese SLE Treatment And Research Group at 4 sites in China.
Trial summary
This is a prospective,open-labelled,multi-center,randomized clinical trial.It compares the clinical efficacy and safety of there 2 drugs in the treatment of relapse active Takayasu's arteritis patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Takayasu Arteritis
- What is being tested?
- Adalimumab Injection and Tofacitinib 5 MG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesChina
- Study dates
- 5 Jan 2022to 15 Jan 2026
- 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
- Patients aged between 18-65 years old;
- Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990;
- relapse active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018;
- Patients who signed the informed consent form.
Who cannot join
- Patients who failed or intolerant to either adalimumab or tofacitinib;
- patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;
- not well controlled diabetes;
- uncontrolled heart failure od renal dysfunction(eGFR<30ml/min);
- Patients with active infection,including tuberculosis, hepatitis B and C,HIV infection, bacteria or fungal infection;
- upper GI bleeding 3 months before enrolement;
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- refractory hypertension;
- Pregnant or intended to be pregnant 3 months after the trial;
- Severe coronary artery involvement demonstrated by CTA;
- severe cranial or cervical or renal artery diseases that need surgery;
- Patients that should not be included by the investigator.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, 100000
Lili Pan, MD, 13720021786, lilypansxmu@sina.com
Taotao Li, MD, 13621314886, litaotao789@sina.com
- Not yet recruiting
The General Hospital of the People's Liberation Army
Beijing, 100000
Jian Zhu, MD, 13671105096, jian_jzhu@126.com
Aihua Wan, 13641380248, 284986094@qq.com
- Not yet recruiting
Beijing Shijitan Hospital
Beijing, 100053
Yuhua Wang, MD, 18610276177, wyhxxtt@163.com
Yawen Shen, MD, 13051581579, songajulia@163.com
- Not yet recruiting
Beijing Xuanwu Hospital
Beijing, 100053
Yi Zhao, MD, 13501164945, zhaoyi_peking@163.com
Fang Kong, MD, 13051116280, kongfang90@163.com
About this study
Official title: An Open-label，Randomized, Controlled, Multicenter Study of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
This is a prospective,open-labelled,multi-center,randomized clinical trial.It compares the clinical efficacy and safety of there 2 drugs in the treatment of relapse active Takayasu's arteritis patients.
Read the detailed description
In this study, 100 relapse Takayasu's arteritis patients will be enrolled. Patients are randomized into the adalimumab treatment group and tofacitinib treatment.Patients will also be treated with reduced dose of glucocorticoid at the same time. The primary end point is the percentage of patients who are in complete response at week 12 and maintain in complete response at week 78.
The efficacy will be evaluated at week 12, 24, 36, 52 and 78. If the patient does not respond to one drug at week 24, then the investigator will shift the treatment to another intervention. Safety is also monitored during the study.
- Conditions
- Takayasu Arteritis
- Being tested
- Adalimumab Injection, Tofacitinib 5 MG
- Medical subject headings
- Takayasu Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab InjectionDrug
Also called An-jian-ning
Adalimumab Injection injected subcutaneously every other week for 78 weeks
Tofacitinib 5 MGDrug
Also called An-shu-zheng
Tofacitinib 5 MG BID taken orally for 78 weeks
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab group | Experimental | Adalimumab 40mg injected subcutaneously every 2 weeks for 78 weeks. Receives: Drug: Adalimumab Injection |
| Tofacitinib 5MG group | Active comparator | Tofacitinib 5mg BID taken orally for 78 weeks. Receives: Drug: Tofacitinib 5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with complete response
percentage of patients with complete response at week 78
Measured: week 78
Secondary outcomes (4)
percentage of patients with partial response
percentage of patients with partial response at week 78
Measured: week 78
Percentage of patients with image progression at the end of study
percentage of patients with progress disease demonstrated by CTA or Doppler at week 78
Measured: week 78
adverse events
safety profile of both Adalimumab and Tofacitinib treatment group
Measured: 78 weeks
intervention procedures
percentage of patients who require intervention procedures during the study period
Measured: 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start5 Jan 2022
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- open-label, multicenter,randomized trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinping Tian, Chinese SLE Treatment And Research Group
- Investigators
- Xiaofeng Zeng, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151848
- Sponsor's protocol ID
- CSTAR-007
- Acronym
- ADATOFTAK
- Status last verified
- Jul 2023
- First submitted
- 6 Nov 2021
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label，Randomized, Controlled, Multicenter Study of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
- ClinicalTrials.gov ID
- NCT05151848
- Acronym / sponsor ID
- ADATOFTAK / CSTAR-007
- Conditions
- Takayasu Arteritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese SLE Treatment And Research GroupUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 9 Dec 2021 (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.
This is a prospective,open-labelled,multi-center,randomized clinical trial.It compares the clinical efficacy and safety of there 2 drugs in the treatment of relapse active Takayasu's arteritis patients.
Detailed description
In this study, 100 relapse Takayasu's arteritis patients will be enrolled. Patients are randomized into the adalimumab treatment group and tofacitinib treatment.Patients will also be treated with reduced dose of glucocorticoid at the same time. The primary end point is the percentage of patients who are in complete response at week 12 and maintain in complete response at week 78.
The efficacy will be evaluated at week 12, 24, 36, 52 and 78. If the patient does not respond to one drug at week 24, then the investigator will shift the treatment to another intervention. Safety is also monitored during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label, multicenter,randomized trial
| Arm | Type | Receives |
|---|---|---|
| Adalimumab group | Experimental | Drug: Adalimumab InjectionAdalimumab 40mg injected subcutaneously every 2 weeks for 78 weeks. |
| Tofacitinib 5MG group | Active comparator | Drug: Tofacitinib 5 MGTofacitinib 5mg BID taken orally for 78 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 18-65 years old;
- Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990;
- relapse active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018;
- Patients who signed the informed consent form.
Key exclusion criteria (11 listed)
- Patients who failed or intolerant to either adalimumab or tofacitinib;
- patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;
- not well controlled diabetes;
- uncontrolled heart failure od renal dysfunction(eGFR<30ml/min);
- Patients with active infection,including tuberculosis, hepatitis B and C,HIV infection, bacteria or fungal infection;
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 |
|---|---|---|
| Adalimumab InjectionAlso: An-jian-ningAdalimumab Injection injected subcutaneously every other week for 78 weeks | Drug | Adalimumab group |
| Tofacitinib 5 MGAlso: An-shu-zhengTofacitinib 5 MG BID taken orally for 78 weeks | Drug | Tofacitinib 5MG group |
Primary outcome
percentage of patients with complete response
Time frame: week 78
percentage of patients with complete response at week 78
4 secondary outcomes
percentage of patients with partial response
Time frame: week 78
Percentage of patients with image progression at the end of study
Time frame: week 78
adverse events
Time frame: 78 weeks
intervention procedures
Time frame: 78 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Xiaofeng Zeng, MD principal investigator
Peking Union Medical College Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab Injection and Tofacitinib 5 MG in people with Takayasu Arteritis, run by Chinese SLE Treatment And Research Group at 4 sites 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 4 inclusion and 11 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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Xinping Tian, MD (8613691165939 ext. 8613691165939, tianxp6@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with complete response (time frame: week 78). 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 24 Jul 2023.