Arthritis, RheumatoidPhase 4NCT04928066
The Efficacy and Safety of Tofacitinib (TF) With Iguratimod (IGU) on RA
A Phase 4 study testing Iguratimod, Tofacitinib and Pred in people with Arthritis, Rheumatoid, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
RA is a common autoimmune disease that causes joint damage.It is necessary to reach the standard as soon as possible and give effective drugs according to the patient's disease activity to avoid disability. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Iguratimod, Tofacitinib and Pred
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 30 Jul 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet the following inclusion criteria will be eligible to participate in the study:
- Patients who meet RA standards in 1987 and 2010 or ERA standards in 2012;
- Age > 18 years old;
- the extrapulmonary manifestations of RA were stable;
- Patients with NSAIDs tolerance;
- DAS28-ESR is highergreater than 2.6.
Who cannot join
- Patients who meet any of the following criteria will be excluded from the study:
- Patients with acute and chronic infection;
- Platelet count < 80*10^9/L, or white blood cell < 3*10^9/L;
- ALT or AST is 2 times higher than the upper limit of normal value;
- Renal insufficiency: serum Cr ≥ 176 umol/L;
- Pregnant or lactating women (breastfeeding);
Show all 10Show fewer
- Have a history of malignant tumor (the cure time is less than 5 years);
- Patients with severe hypertension and cardiac insufficiency;
- Other diseases or conditions in which immune suppressants cannot be used;
- People who are allergic to TF.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Tofacitinib (TF) Combined With Iguratimod(IGU) in the Treatment of Moderate to Severe Active Rheumatoid Arthritis (RA)
RA is a common autoimmune disease that causes joint damage.It is necessary to reach the standard as soon as possible and give effective drugs according to the patient's disease activity to avoid disability. Tofacitinib(TF) is a new type of oral tyrosine kinase inhibitor (JAKi) for the treatment of moderate to severe active RA. However, there is alack of Chinese data on the joint scheme, long-term use, maintenance and stop of TF in the real world. We will use the new JAK combination regimen to treat RA patients, and carry out long-term clinical follow-up for 30 weeks.
Read the detailed description
Objective: To observe the clinical efficacy and safety of TF combined with/ without IGU for 30 weeks in patients with moderate to severe active RA with different clinical characteristics and subgroups by using a prospective cohort , and to find the best combination scheme of TF.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Iguratimod, Tofacitinib, Pred
- Keywords
- Tofacitinib, Iguratimod
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IguratimodDrug
Also called IGU, T-614
Iguratimod tablet，25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.
TofacitinibDrug
Also called TF
Tofacitinib,5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.
PredDrug
Also called Prednisone
Pred, 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib (TF)+Iguratimod (IGU) | Experimental | Drug: Iguratimod（IGU），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Tofacitinib（TF），5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Prednisone （Pred）： 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response. Receives: Drug: Iguratimod; Drug: Tofacitinib; Drug: Pred |
| Tofacitinib (TF) | Other | Drug: Tofacitinib（TF），5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Prednisone （Pred）： 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response. Receives: Drug: Tofacitinib; Drug: Pred |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who achieve clinical remission at week 30 using European League Against Rheumatism (EULAR) response criteria DAS28
The percentage of patients whose Disease Activity Score in 28 Joints (DAS28) achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2). The DAS28 is a composite score derived from 4 of these measures，that is the count of tender joint count（TJC, 0-28）and swollen joint count（SJC, 0-28）, measure erythrocyte sedimentation rate (ESR, mm/h) or C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity i.e. 'global assessment of health' (GH) using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst. DAS28 values were calculated as follows: DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x GH. High disease activity: DAS28-ESR > 5.1; Moderate disease activity: 5.1≥ DAS28 > 3.2 to 5.1; Low disease activity (LDA) and Remission mean Clinical remission.
Measured: week 30
Secondary outcomes (16)
The percentage of patients who achieve clinical remission using DAS28-ESR at week 18
The percentage of patients whose DAS28 achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2) at week 18.
Measured: week 18
The percentage of patients who achieve clinical remission using DAS28-ESR at week 6
The percentage of patients whose DAS28 achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2) at week 18.
Measured: week 6
Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 30
△DAS28 indicates the decline of DAS28-ESR from the baseline to week 30. EULAR response states were classified as follows: good responders were patients with an improvement from baseline (△DAS28-ESR) of > 1.2 and a DAS28-ESR at week 30 ≤ 3.2. Moderate responders: △DAS28 > 1.2 and still DAS28 > 3.2 at week 30, or 1.2 ≥△DAS28 > 0.6 and DAS28 ≤ 5.1 at week 30. Nonresponders：△DAS28 ≤0.6 or DAS28 >5.1 at week 30. DAS28-defined remission was classified as a score of <2.6.
Measured: week 30
Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 18
EULAR response states were classified as follows: DAS28-ESR Good responders: △DAS28 > 1.2 and DAS28 ≤3.2 at week 18. Moderate responders：△DAS28 > 1.2 and still DAS28 > 3.2 at week 18; or 1.2 ≥△DAS28 > 0.6 and DAS28 ≤ 5.1 at week 18. Nonresponders：△DAS28 ≤0.6，or DAS28 >5.1 at week 18. DAS28-defined remission was classified as a score of <2.6.
Measured: week 18
Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 6
EULAR response states were classified as follows: DAS28-ESR Good responders: △DAS28 > 1.2 and DAS28 ≤3.2 at week 6. Moderate responders：△DAS28 > 1.2 and still DAS28 > 3.2 at week 6; or 1.2 ≥△DAS28 > 0.6 and DAS28 ≤ 5.1 at week 6. Nonresponders：△DAS28 ≤0.6，or DAS28 >5.1 at week 6. DAS28-defined remission was classified as a score of <2.6.
Measured: week 6
Percentage of participants achieving ACR/EULAR remission at week 30
If all of the following 4 parameters are fulfilled, it is defined as remission: TJC ≤ 1, SJC ≤ 1, CRP ≤ 1 mg/dL, Patient global assessment（PGA） ≤ 1 cm (on a visual analog scale ranging from 0-10 cm, with higher scores indicating severe disease).
Measured: week 30
Percentage of participants achieving ACR/EULAR remission at week 18
If all of the following 4 parameters are fulfilled, it is defined as remission: TJC ≤ 1, SJC ≤ 1, CRP ≤ 1 mg/dL, Patient global assessment（PGA） ≤ 1 cm (on a visual analog scale ranging from 0-10 cm, with higher scores indicating severe disease).
Measured: week 18
Percentage of participants achieving ACR/EULAR remission at week 6
If all of the following 4 parameters are fulfilled, it is defined as remission: TJC ≤ 1, SJC ≤ 1, CRP ≤ 1 mg/dL, Patient global assessment（PGA） ≤ 1 cm (on a visual analog scale ranging from 0-10 cm, with higher scores indicating severe disease).
Measured: week 6
Change from baseline Simplified Disease Activity Index (SDAI)
The SDAI is a composite score derived from these measures，that is the count of tender joint count（TJC, 0-28）, swollen joint count（SJC, 0-28）, C-reactive protein (CRP, mg/L), Patient global assessment（PGA）and physician global assessment（PHGA）, each of the last two was assessed on a visual analog scale ranging from 0-10 cm, with higher scores indicating severe disease. SDAI score will be calculated with formula SDAI = TJC + SJC + PGA+PHGA+ CRP. SDAI score exceeding 26 is considered high disease activity; 11 <SDAI ≤26，moderate disease activity; 3.3 <SDAI ≤11, low disease activity; remission is SDAI score ≤ 3.3.
Measured: up to week 30
Change from baseline Clinical Disease Activity Index (CDAI)
Change from baseline Clinical Disease Activity Index (CDAI) CDAI is a composite score derived from these measures，that is the count of tender joint count（TJC, 0-28）, swollen joint count（SJC, 0-28）, Patient global assessment（PGA）and physician global assessment（PHGA）, each of the last two was CDAI score will be calculated with formula CDAI = TJC + SJC + PGA + PHGA. CDAI > 22 is considered high disease activity; 10 <CDAI ≤ 22, moderate disease activity; 2.8 <CDAI ≤10, low disease activity; remission is CDAI score ≤2.8.
Measured: up to week 30
Change From Baseline in C-reactive Protein (CRP)
Change from Baseline in C-reactive Protein (CRP), a component index of ACR20 and SDAI, CRP will be measured with blood samples.
Measured: up to week 30
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Change from Baseline in ESR, that is a component index of ACR20, DAS28-ESR and SDAI, ESR will be measured with blood samples.
Measured: up to week 30
Change from baseline Health Assessment Questionnaire Disability Index (HAQ-DI)
Change from Baseline in HAQ-DI, a participant assessed measure of health assessment, shaveing eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item on a single scale has 4 degrees ranging from 0 (no functional difficulty) to 3 (unable to do), with higher scores indicating severe disease.
Measured: up to week 30
Percentage of American College of Rheumatology [ACR] 20 Criteria Responders every time
Percentage of American College of Rheumatology [ACR] 20 Criteria Responders every time
Measured: up to week 30
Incidence of participant withdrawal
Percentage of participants who withdraw from this study.
Measured: up to week 30
Number of participants with"adverse events (AEs)"
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with"adverse events (AEs)"i.e. physical exam abnormalities，vital sign abnormalities，laboratory value abnormalities，symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Measured: up to week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start1 Mar 2020
- Primary completion30 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Shu, Qilu Hospital of Shandong University
- Investigators
- Xiaoyun Yang, Dr., Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928066
- Sponsor's protocol ID
- Tofacitinib-RA QiluH
- Status last verified
- Nov 2023
- First submitted
- 9 Jun 2021
- Last updated
- 18 Nov 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tofacitinib (TF) Combined With Iguratimod(IGU) in the Treatment of Moderate to Severe Active Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT04928066
- Acronym / sponsor ID
- Tofacitinib-RA QiluH
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Tofacitinib, Iguratimod
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 16 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.
RA is a common autoimmune disease that causes joint damage.It is necessary to reach the standard as soon as possible and give effective drugs according to the patient's disease activity to avoid disability. Tofacitinib(TF) is a new type of oral tyrosine kinase inhibitor (JAKi) for the treatment of moderate to severe active RA. However, there is alack of Chinese data on the joint scheme, long-term use, maintenance and stop of TF in the real world. We will use the new JAK combination regimen to treat RA patients, and carry out long-term clinical follow-up for 30 weeks.
Detailed description
Objective: To observe the clinical efficacy and safety of TF combined with/ without IGU for 30 weeks in patients with moderate to severe active RA with different clinical characteristics and subgroups by using a prospective cohort , and to find the best combination scheme of TF.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib (TF)+Iguratimod (IGU) | Experimental | Drug: Iguratimod, Drug: Tofacitinib, Drug: PredDrug: Iguratimod（IGU），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Tofacitinib（TF），5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Prednisone （Pred）： 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response. |
| Tofacitinib (TF) | Other | Drug: Tofacitinib, Drug: PredDrug: Tofacitinib（TF），5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Prednisone （Pred）： 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who meet the following inclusion criteria will be eligible to participate in the study:
- Patients who meet RA standards in 1987 and 2010 or ERA standards in 2012;
- Age > 18 years old;
- the extrapulmonary manifestations of RA were stable;
- Patients with NSAIDs tolerance;
Key exclusion criteria (10 listed)
- Patients with acute and chronic infection;
- Platelet count < 80*10^9/L, or white blood cell < 3*10^9/L;
- ALT or AST is 2 times higher than the upper limit of normal value;
- Renal insufficiency: serum Cr ≥ 176 umol/L;
- Pregnant or lactating women (breastfeeding);
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 |
|---|---|---|
| IguratimodAlso: IGU, T-614Iguratimod tablet，25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint. | Drug | Tofacitinib (TF)+Iguratimod (IGU) |
| TofacitinibAlso: TFTofacitinib,5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint. | Drug | Tofacitinib (TF), Tofacitinib (TF)+Iguratimod (IGU) |
| PredAlso: PrednisonePred, 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response. | Drug | Tofacitinib (TF), Tofacitinib (TF)+Iguratimod (IGU) |
Primary outcome
The percentage of patients who achieve clinical remission at week 30 using European League Against Rheumatism (EULAR) response criteria DAS28
Time frame: week 30
The percentage of patients whose Disease Activity Score in 28 Joints (DAS28) achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2). The DAS28 is a composite score derived from 4 of these measures，that is the count of tender joint count（TJC, 0-28）and swollen joint count（SJC, 0-28）, measure erythrocyte sedimentation rate (ESR, mm/h) or C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity i.e. 'global assessment of health' (GH) using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst. DAS28 values were calculated as follows: DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x GH. High disease activity: DAS28-ESR > 5.1; Moderate disease activity: 5.1≥ DAS28 > 3.2 to 5.1; Low disease activity (LDA) and Remission mean Clinical remission.
16 secondary outcomes
The percentage of patients who achieve clinical remission using DAS28-ESR at week 18
Time frame: week 18
The percentage of patients who achieve clinical remission using DAS28-ESR at week 6
Time frame: week 6
Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 30
Time frame: week 30
Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 18
Time frame: week 18
Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 6
Time frame: week 6
Percentage of participants achieving ACR/EULAR remission at week 30
Time frame: week 30
Percentage of participants achieving ACR/EULAR remission at week 18
Time frame: week 18
Percentage of participants achieving ACR/EULAR remission at week 6
Time frame: week 6
Change from baseline Simplified Disease Activity Index (SDAI)
Time frame: up to week 30
Change from baseline Clinical Disease Activity Index (CDAI)
Time frame: up to week 30
Change From Baseline in C-reactive Protein (CRP)
Time frame: up to week 30
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Time frame: up to week 30
Change from baseline Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: up to week 30
Percentage of American College of Rheumatology [ACR] 20 Criteria Responders every time
Time frame: up to week 30
Incidence of participant withdrawal
Time frame: up to week 30
Number of participants with"adverse events (AEs)"
Time frame: up to week 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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.
Xiaoyun Yang, Dr. study director
Qilu Hospital of Shandong University
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 Iguratimod, Tofacitinib and Pred in people with Arthritis, Rheumatoid, run by Qilu Hospital of Shandong University 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 18 Nov 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients who achieve clinical remission at week 30 using European League Against Rheumatism (EULAR) response criteria DAS28 (time frame: week 30). 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 18 Nov 2023.