Rheumatoid ArthritisPhase 4NCT05606107
To Compare the Efficacy and Safety of Low-dose Glucocorticoids and Tofacitinib in Alleviating Moderate to High Disease Activity Rheumatoid Arthritis for 24 Weeks
A Phase 4 study testing Tofacitinib and Glucocorticoid in people with Rheumatoid Arthritis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites in China.
Trial summary
Glucocorticoids are effective in the treatment of rheumatoid arthritis, but long-term use of glucocorticoids has many side effects. Tofacitinib is a new small-molecule drug targeting JAK, which has been found to act quickly. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tofacitinib and Glucocorticoid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 5 sitesChina
- Study dates
- 20 May 2022to 31 Dec 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years;
- met the 2010 ACR and EULAR diagnostic criteria for rheumatoid arthritis (RA), and was diagnosed as RA;
- After more than 3 months of initial treatment or conventional DMARDs treatment, the disease was still in medium-high disease activity, and DAS28-CRP>3.2;
- No birth plan during and within 3 months after the end of the study;
- Voluntarily sign the informed consent form.
Who cannot join
- Patients who are using or have used glucocorticoids, tofacitib and biological agents in the past 3 months;
- At the time of screening, patients were in the acute phase of acute infection or chronic infection;
- Laboratory test results: Hb<100g/L; White blood cell count <4.0×10^9/L; Platelets <100×10^9/L; Liver function (transaminase, bilirubin)> 2 times the upper limit of normal value; Renal function (SCr) > the upper limit of normal;
- Active gastrointestinal disease: gastrointestinal bleeding or active gastrointestinal ulcer and acute gastric mucosal injury diagnosed by gastroenteroscopy in the past three months;
- A history of severe cardiovascular, cerebrovascular, kidney and other important organs, blood and endocrine system lesions, malignant tumors and thrombosis;
- suffering from serious, progressive and uncontrolled diseases of other important organs and systems;
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- mental disease patients;
- Other conditions deemed unsuitable for trial participation by the investigator;
- Pregnancy tests of women of childbearing age were positive.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Changxing Country People's Hospital
Changxing
Wang yingying
- Not yet recruiting
Jiaxing Central Hospital
Jiaxing
Wang Hongzhi
- Recruiting
Jinhua Central Hospital
Jinhua
Du Hongwei
- Recruiting
Shaoxing Central Hospital
Shaoxing
Hou Tao
- Recruiting
Zhuji People's Hospital
Zhuji
Guan Ying
About this study
Glucocorticoids are effective in the treatment of rheumatoid arthritis, but long-term use of glucocorticoids has many side effects. Tofacitinib is a new small-molecule drug targeting JAK, which has been found to act quickly. The aim of this clinical trial was to investigate the efficacy and safety of tofacitinib and low-dose glucocorticoids in inducing remission in patients with rheumatoid arthritis with moderate to high disease activity.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tofacitinib, Glucocorticoid
- Keywords
- rheumatoid arthritis, moderate disease activity, high disease activity
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
Tofacitinib combined with other csDMARDs, but no glucocorticoids.
GlucocorticoidDrug
Glucocorticoid
| Study group | Role | What they receive |
|---|---|---|
| Glucocorticoid group | Active comparator | Not described Receives: Drug: Glucocorticoid |
| Tofacitinib group | Experimental | Not described Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS28-CRP
Disease activity
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start20 May 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiaxing Hospital of Traditional Chinese Medicine, Jinhua Municipal Central Hospital, SAHZU.CHANGXING CAMPUS, Zhuji People's Hospital of Zhejiang Province, Shaoxing People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606107
- Sponsor's protocol ID
- 2022-0159
- Status last verified
- Oct 2022
- First submitted
- 1 Nov 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Efficacy and Safety of Low-dose Glucocorticoids and Tofacitinib in Alleviating Moderate to High Disease Activity Rheumatoid Arthritis for 24 Weeks
- ClinicalTrials.gov ID
- NCT05606107
- Acronym / sponsor ID
- 2022-0159
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, moderate disease activity, high disease activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Jiaxing Hospital of Traditional Chinese Medicine, Jinhua Municipal Central Hospital, SAHZU.CHANGXING CAMPUS, Zhuji People's Hospital of Zhejiang Province, Shaoxing People's Hospital
- Study start
- 20 May 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Nov 2022 (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.
Glucocorticoids are effective in the treatment of rheumatoid arthritis, but long-term use of glucocorticoids has many side effects. Tofacitinib is a new small-molecule drug targeting JAK, which has been found to act quickly. The aim of this clinical trial was to investigate the efficacy and safety of tofacitinib and low-dose glucocorticoids in inducing remission in patients with rheumatoid arthritis with moderate to high disease activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucocorticoid group | Active comparator | Drug: Glucocorticoid |
| Tofacitinib group | Experimental | Drug: Tofacitinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70 years;
- met the 2010 ACR and EULAR diagnostic criteria for rheumatoid arthritis (RA), and was diagnosed as RA;
- After more than 3 months of initial treatment or conventional DMARDs treatment, the disease was still in medium-high disease activity, and DAS28-CRP>3.2;
- No birth plan during and within 3 months after the end of the study;
- Voluntarily sign the informed consent form.
Key exclusion criteria (9 listed)
- Patients who are using or have used glucocorticoids, tofacitib and biological agents in the past 3 months;
- At the time of screening, patients were in the acute phase of acute infection or chronic infection;
- Laboratory test results: Hb<100g/L; White blood cell count <4.0×10^9/L; Platelets <100×10^9/L; Liver function (transaminase, bilirubin)> 2 times the upper limit of normal value; Renal function (SCr) > the upper limit of normal;
- Active gastrointestinal disease: gastrointestinal bleeding or active gastrointestinal ulcer and acute gastric mucosal injury diagnosed by gastroenteroscopy in the past three months;
- A history of severe cardiovascular, cerebrovascular, kidney and other important organs, blood and endocrine system lesions, malignant tumors and thrombosis;
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 |
|---|---|---|
| TofacitinibTofacitinib combined with other csDMARDs, but no glucocorticoids. | Drug | Tofacitinib group |
| GlucocorticoidGlucocorticoid | Drug | Glucocorticoid group |
Primary outcome
DAS28-CRP
Time frame: 24 weeks
Disease activity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
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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.
5 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 Tofacitinib and Glucocorticoid in people with Rheumatoid Arthritis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 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 5 inclusion and 9 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 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 Wu Huaxiang, Doctor (13757118395, wuhx8855@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAS28-CRP (time frame: 24 weeks). 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 4 Nov 2022.