Rheumatoid ArthritisPhase 4NCT04927000
The Role of Tofacitinib in Steroid Withdrawal in Rheumatoid Arthritis
A Phase 4 study testing Tofacitinib in people with Rheumatoid Arthritis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Rheumatoid arthritis (RA) is a systemic chronic arthritis characterized by systemic inflammation, persistent synovitis and final joint destruction Inflammatory diseases can lead to decreased productivity and impaired health-related quality of life. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tofacitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2021to 30 Dec 2023
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of rheumatoid arthritis female gender, 30 to 65 years old, all patients the traditional DMARDs combined with glucocorticoid for 1 month (glucocorticoid dosage 10-15mg/ day) was used, and DAS28 score was large than 3.2, consider that the disease is still active.
Who cannot join
- other connective tissue diseases, neurological diseases, major depression, cardiovascular disease, latent tuberculosis, tumor, severe liver and kidney dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
Xuyan Yang, PhD, 13819186380, hangzhouyxy@zju.edu.cn
About this study
Rheumatoid arthritis (RA) is a systemic chronic arthritis characterized by systemic inflammation, persistent synovitis and final joint destruction Inflammatory diseases can lead to decreased productivity and impaired health-related quality of life. As a chronic disease, rheumatoid Chronic arthritis needs long-term treatment. At the same time, RA can cause skin, eye, lung, liver, kidney, blood and cardiovascular diseases All of them were extraarticular lesions. It causes a heavy burden to the patients themselves, their families and the society. The main clinical manifestations of RA were morning stiffness Joint swelling and pain, cartilage destruction and joint space narrowing, if not treated, will lead to joint destruction, deformity and dysfunction The rate of disability is high. As a new drug in the treatment of RA, tofacitinib can relieve RA symptoms and promote joint healing It can recover the injury and correct the abnormal immune function. At present, studies have proved that the traditional anti rheumatic drugs are ineffective in the treatment of RA. The addition of tofacitinib to patients may be beneficial to the treatment.
Read the detailed description
Participant inclusion and selection criteria: A total of 170 patients with rheumatoid arthritis were enrolled.
Inclusion criteria: The diagnosis of rheumatoid arthritis of patients must meet the ACR 1987 classification criteria for rheumatoid arthritis, female, aged 30-65 years old, all The patients have been using traditional dMARDs combined with glucocorticoid for 1 month (glucocorticoid dosage 10-15mg/day), and the DAS28 scores are all greater than 3.2, considering that the disease is still active.
Exclusion criteria: Including other connective tissue diseases, neurological diseases, combined depression, ongoing antidepressant treatment, severe cardiovascular disease, latent tuberculosis, tumors, severe liver and kidney dysfunction.
Randomly divided into two groups: tofacitinib treatment group and control group with 85 cases each. The probability of patients being classified into different groups: both are 50%.
Control group: basic dMARDs of all subjects: methotrexate (10mg) combined with [(sulfasalazine (2g/day), isilamod (50mg/day), leflunomide (20mg/day)] One or two of the two. All subjects used glucocorticoids (10-15 mg/day).
Tofacitinib group: combined with tofacitinib 5mg/twice a day on the basis of the above scheme.
All patients will be evaluated once a month for the first three months, including the DAS28 score, serum C-reactive protein, erythrocyte sedimentation rate, liver and kidney function and other serological indicators. After three months, the disease will be evaluated once 1-2 months. The assessment content is the same as above. .
Research endpoints: 1. After treatment, the DAS28 score is less than 2.6, considering the disease remission, gradually reduce the dose to stop the hormone. 2. Hormone use for more than 6 months cannot be reduced or stopped or if the condition worsens, consider adding other dMARDs or biological agents to control the condition. 3. The test needs to be terminated in case of serious adverse reactions. All subjects recorded the time when hormones were stopped and the total amount of hormones used.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tofacitinib
- Keywords
- Rheumatoid arthritis, tofacitinib, dsease remission
- 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
Also called Xeljanz
in tofacitinib treatment group，we added tofacitinib 5mg/BID in the basic treatment in all subjects.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | All subjects used one or two the basic DMARDs: Methotrexate (10mg) combined with sulfasalazine (2G / day), Iguratimod (50 mg / day), leflunomide (20 mg / day)]. All subjects were treated with Glucocorticoid (10-15mg)/Days). |
| Tofacitinib treatment group | Experimental | All subjects used one or two the basic DMARDs: Methotrexate (10mg) combined with sulfasalazine (2G / day), Iguratimod (50 mg / day), leflunomide (20 mg / day)].
All subjects were treated with Glucocorticoid (10-15mg)/Days). All subjects were treated with Tofacitinib 5mg/BID. Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease remission of rheumatoid arthritis patients
Disease Activity Score 28 score(DAS28). DAS28>3.2 means disease active，DAS28 <2.6 means disease remission
Measured: through study completion，an average of 1 year
Disease remission of rheumatoid arthritis patients
Liver and kidney function were measured with a BN ProSpec System. Alanine aminotransferase more than three times of the normal value and eGRF<60 were exclued for further study.
Measured: through study completion，an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start31 May 2021
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Dec 2023 (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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927000
- Sponsor's protocol ID
- 2020-388
- Status last verified
- Jul 2020
- First submitted
- 31 May 2021
- Last updated
- 15 Jun 2021
- 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 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Tofacitinib in Steroid Withdrawal in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04927000
- Acronym / sponsor ID
- 2020-388
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, tofacitinib, dsease remission
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 31 May 2021 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 15 Jun 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.
Rheumatoid arthritis (RA) is a systemic chronic arthritis characterized by systemic inflammation, persistent synovitis and final joint destruction Inflammatory diseases can lead to decreased productivity and impaired health-related quality of life. As a chronic disease, rheumatoid Chronic arthritis needs long-term treatment. At the same time, RA can cause skin, eye, lung, liver, kidney, blood and cardiovascular diseases All of them were extraarticular lesions. It causes a heavy burden to the patients themselves, their families and the society. The main clinical manifestations of RA were morning stiffness Joint swelling and pain, cartilage destruction and joint space narrowing, if not treated, will lead to joint destruction, deformity and dysfunction The rate of disability is high. As a new drug in the treatment of RA, tofacitinib can relieve RA symptoms and promote joint healing It can recover the injury and correct the abnormal immune function. At present, studies have proved that the traditional anti rheumatic drugs are ineffective in the treatment of RA. The addition of tofacitinib to patients may be beneficial to the treatment.
Detailed description
Participant inclusion and selection criteria: A total of 170 patients with rheumatoid arthritis were enrolled.
Inclusion criteria: The diagnosis of rheumatoid arthritis of patients must meet the ACR 1987 classification criteria for rheumatoid arthritis, female, aged 30-65 years old, all The patients have been using traditional dMARDs combined with glucocorticoid for 1 month (glucocorticoid dosage 10-15mg/day), and the DAS28 scores are all greater than 3.2, considering that the disease is still active.
Exclusion criteria: Including other connective tissue diseases, neurological diseases, combined depression, ongoing antidepressant treatment, severe cardiovascular disease, latent tuberculosis, tumors, severe liver and kidney dysfunction.
Randomly divided into two groups: tofacitinib treatment group and control group with 85 cases each. The probability of patients being classified into different groups: both are 50%.
Control group: basic dMARDs of all subjects: methotrexate (10mg) combined with [(sulfasalazine (2g/day), isilamod (50mg/day), leflunomide (20mg/day)] One or two of the two. All subjects used glucocorticoids (10-15 mg/day).
Tofacitinib group: combined with tofacitinib 5mg/twice a day on the basis of the above scheme.
All patients will be evaluated once a month for the first three months, including the DAS28 score, serum C-reactive protein, erythrocyte sedimentation rate, liver and kidney function and other serological indicators. After three months, the disease will be evaluated once 1-2 months. The assessment content is the same as above. .
Research endpoints: 1. After treatment, the DAS28 score is less than 2.6, considering the disease remission, gradually reduce the dose to stop the hormone. 2. Hormone use for more than 6 months cannot be reduced or stopped or if the condition worsens, consider adding other dMARDs or biological agents to control the condition. 3. The test needs to be terminated in case of serious adverse reactions. All subjects recorded the time when hormones were stopped and the total amount of hormones used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –All subjects used one or two the basic DMARDs: Methotrexate (10mg) combined with sulfasalazine (2G / day), Iguratimod (50 mg / day), leflunomide (20 mg / day)]. All subjects were treated with Glucocorticoid (10-15mg)/Days). |
| Tofacitinib treatment group | Experimental | Drug: TofacitinibAll subjects used one or two the basic DMARDs: Methotrexate (10mg) combined with sulfasalazine (2G / day), Iguratimod (50 mg / day), leflunomide (20 mg / day)]. All subjects were treated with Glucocorticoid (10-15mg)/Days). All subjects were treated with Tofacitinib 5mg/BID. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of rheumatoid arthritis female gender, 30 to 65 years old, all patients the traditional DMARDs combined with glucocorticoid for 1 month (glucocorticoid dosage 10-15mg/ day) was used, and DAS28 score was large than 3.2, consider that the disease is still active.
Key exclusion criteria (1 listed)
- other connective tissue diseases, neurological diseases, major depression, cardiovascular disease, latent tuberculosis, tumor, severe liver and kidney dysfunction.
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 |
|---|---|---|
| TofacitinibAlso: Xeljanzin tofacitinib treatment group，we added tofacitinib 5mg/BID in the basic treatment in all subjects. | Drug | Tofacitinib treatment group |
Primary outcome
Disease remission of rheumatoid arthritis patients
Time frame: through study completion，an average of 1 year
Disease Activity Score 28 score(DAS28). DAS28>3.2 means disease active，DAS28 <2.6 means disease remission
Disease remission of rheumatoid arthritis patients
Time frame: through study completion，an average of 1 year
Liver and kidney function were measured with a BN ProSpec System. Alanine aminotransferase more than three times of the normal value and eGRF<60 were exclued for further study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
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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.
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 Tofacitinib in people with Rheumatoid Arthritis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 1 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 15 Jun 2021. 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 xuyan U yang, PHD (+8613819186380, hangzhouyxy@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease remission of rheumatoid arthritis patients (time frame: through study completion，an average of 1 year). The study lists 2 primary outcomes in all. 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 15 Jun 2021.