Takayasu ArteritisPhase 3TOFGCTAKNCT05749666
Comparison of Tofacitinib and Prednisolone in the Treatment of Active Takayasu's Arteritis
A Phase 3 study testing Tofacitinib 5 MG and Prednisolone in people with Takayasu Arteritis, run by Chinese SLE Treatment And Research Group at 1 site in China.
Trial summary
This is a prospective, double-blinded, single center, randomized clinical trial. It compares the clinical efficacy and safety of thees 2 drugs in the treatment of 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?
- Tofacitinib 5 MG and Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2023to 20 Jul 2025
- Phase
- Phase 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 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;
- Active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018 or Kerr's criteria by NIH;
- Patients who signed the informed consent form.
Who cannot join
- Patients who failed or intolerant to either tofacitinib or its similar drugs;
- Patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;
- Not well controlled diabetes;
- Moderate and severe hyperlipedimia;
- Patients with history of thrombus;
- Uncontrolled heart failure od renal dysfunction (eGFR <30ml/min);
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- Patients with active infection, including tuberculosis, hepatitis B and C, HIV infection, bacterial or fungal infection;
- Upper GI bleeding happened in 3 months before enrollment;
- Refractory hypertension;
- Pregnant or intended to be pregnant recently;
- Severe coronary artery involvement demonstrated by CTA;
- Severe cranial or cervical or renal artery diseases that need surgery;
- Patients that should not be included judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Xinping Tian, MD, 86-13691165939, tianxp6@126.com
Shi Rong, MD, 86-13601248311, rongshipumch@126.com
About this study
Official title: A Prospective Randomized Double-blinded Controlled Single Center Clinical Study of the Efficacy and Safety for Tofacitinib Compared With Glucocorticoid in the Remission-reduction Treatment of Active Takayasu's Arteritis
This is a prospective, double-blinded, single center, randomized clinical trial. It compares the clinical efficacy and safety of thees 2 drugs in the treatment of active Takayasu's arteritis patients.
Read the detailed description
In this study, 40 Takayasu's arteritis patients with active disease will be enrolled. Patients are randomized into the tofacitinib treatment group and prednisolone treatment group. Patients will follow the same reduction steps for prednisolone and its placebo. The primary end point is the percentage of patients who are in complete response at week 24.
The efficacy will be evaluated at week 4, 12 and 24. Safety is also monitored during the study.
- Conditions
- Takayasu Arteritis
- Being tested
- Tofacitinib 5 MG, Prednisolone, Placebo of tofacitinib 5mg, Placebo of prednisolone
- Keywords
- Tofacitinib, prednisolone
- Medical subject headings
- Takayasu Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib 5 MGDrug
Tofacitinib 5 MG BID taken orally for 24 weeks
PrednisoloneDrug
Prednisolone taken daily according to preset tapering protocol
Placebo of tofacitinib 5mgOther
Placebo of tofacitinib 5mg BID taken orally for 24 weeks
Placebo of prednisoloneOther
Placebo of prednisolone taken daily according to preset tapering protocol for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib group | Experimental | Tofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period Receives: Drug: Tofacitinib 5 MG; Other: Placebo of prednisolone |
| Prednisolone group | Active comparator | Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks Receives: Drug: Prednisolone; Other: Placebo of tofacitinib 5mg |
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 24
Measured: week 24
Secondary outcomes (7)
Percentage of patients with partial response
Percentage of patients with partial response at week 24
Measured: week 24
Percentage of patients with adverse events due to treatment of tofacitinib
Percentage of patients with adverse events due to treatment of tofacitinib at week 24
Measured: 24 weeks
Percentage of patients with adverse events due to treatment of prednisolone
Percentage of patients with adverse events due to treatment of prednisolone at week 24
Measured: 24 weeks
Percentage of patients with progression, no change, and improvement in vessel image at the end of study
Percentage of patients with progress disease, stable disease, and improved disease demonstrated by CTA, MRI or Doppler at week 24
Measured: week 24
Intervention procedures
Percentage of patients who require intervention procedures during the study period
Measured: 24 weeks
Complication of Takayasu's arteritis
Complication of Takayasu's arteritis happened during 24 weeks
Measured: 24 weeks
Glucocorticoid toxicity index
Glucocorticoid toxicity index at week 24 which indicate the toxicity of prednisolone.
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start20 Jan 2023
- Primary completion20 Jul 2025 (estimated)
- Study completion20 Jul 2025 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 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
- Xinping Tian, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749666
- Sponsor's protocol ID
- CSTAR-009
- Acronym
- TOFGCTAK
- Status last verified
- Feb 2023
- First submitted
- 19 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Double-blinded Controlled Single Center Clinical Study of the Efficacy and Safety for Tofacitinib Compared With Glucocorticoid in the Remission-reduction Treatment of Active Takayasu's Arteritis
- ClinicalTrials.gov ID
- NCT05749666
- Acronym / sponsor ID
- TOFGCTAK / CSTAR-009
- Conditions
- Takayasu Arteritis
- Keywords
- Tofacitinib, prednisolone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese SLE Treatment And Research GroupUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 20 Jul 2025 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 1 Mar 2023 (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, double-blinded, single center, randomized clinical trial. It compares the clinical efficacy and safety of thees 2 drugs in the treatment of active Takayasu's arteritis patients.
Detailed description
In this study, 40 Takayasu's arteritis patients with active disease will be enrolled. Patients are randomized into the tofacitinib treatment group and prednisolone treatment group. Patients will follow the same reduction steps for prednisolone and its placebo. The primary end point is the percentage of patients who are in complete response at week 24.
The efficacy will be evaluated at week 4, 12 and 24. Safety is also monitored during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib group | Experimental | Drug: Tofacitinib 5 MG, Other: Placebo of prednisoloneTofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period |
| Prednisolone group | Active comparator | Drug: Prednisolone, Other: Placebo of tofacitinib 5mgPrednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 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;
- Active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018 or Kerr's criteria by NIH;
- Patients who signed the informed consent form.
Key exclusion criteria (13 listed)
- Patients who failed or intolerant to either tofacitinib or its similar drugs;
- Patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;
- Not well controlled diabetes;
- Moderate and severe hyperlipedimia;
- Patients with history of thrombus;
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 |
|---|---|---|
| Tofacitinib 5 MGTofacitinib 5 MG BID taken orally for 24 weeks | Drug | Tofacitinib group |
| PrednisolonePrednisolone taken daily according to preset tapering protocol | Drug | Prednisolone group |
| Placebo of tofacitinib 5mgPlacebo of tofacitinib 5mg BID taken orally for 24 weeks | Other | Prednisolone group |
| Placebo of prednisolonePlacebo of prednisolone taken daily according to preset tapering protocol for 24 weeks | Other | Tofacitinib group |
Primary outcome
Percentage of patients with complete response
Time frame: week 24
Percentage of patients with complete response at week 24
7 secondary outcomes
Percentage of patients with partial response
Time frame: week 24
Percentage of patients with adverse events due to treatment of tofacitinib
Time frame: 24 weeks
Percentage of patients with adverse events due to treatment of prednisolone
Time frame: 24 weeks
Percentage of patients with progression, no change, and improvement in vessel image at the end of study
Time frame: week 24
Intervention procedures
Time frame: 24 weeks
Complication of Takayasu's arteritis
Time frame: 24 weeks
Glucocorticoid toxicity index
Time frame: week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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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.
Xinping Tian, MD principal investigator
Peking 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 3 study testing Tofacitinib 5 MG and Prednisolone in people with Takayasu Arteritis, run by Chinese SLE Treatment And Research Group 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 4 inclusion and 13 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 1 Mar 2023. 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 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 Xinping Tian, MD (+86-13691165939, 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 24). 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 1 Mar 2023.