Rheumatoid ArthritisPhase 3NCT04333771
A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis
A Phase 3 study testing SHR0302 in people with Rheumatoid Arthritis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with moderate to severe active rheumatoid arthritis who had inadequate response to conventional synthetic DMARDs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- SHR0302
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 566 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2020to 21 Sep 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide signed informed consent.
- RA diagnosis consistent with the 2010 ACR/EULAR criteria;
- Moderate to severe RA defined by 6 or more tender joints, 6 or more swollen joints (68- or 66-joint count), and an ESR of 28 mm/h or greater or a CRP level greater than 5mg/L.
- Subjects were required to have an inadequate response to treatment with csDMARDs before baseline.
- If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already.
- BMI ≥18 kg/m2
Who cannot join
- Pregnant women or refuse to receive contraception during the study.
- Lab abnormality within 4 weeks of randomization as follows: WBC count <3.0×10^9/L；neutrophil count<1.5×10^9/L;hemoglobin level<90.0 g/L ; platelet count <100×10^9/L; AST or ALT levels greater than the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
- History of another autoimmune rheumatic disease ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
- Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 3 months of randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Moderate to Severe Active Rheumatoid Arthritis Subjects With Inadequate Response to csDMARDs.
This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with moderate to severe active rheumatoid arthritis who had inadequate response to conventional synthetic DMARDs.
- Conditions
- Rheumatoid Arthritis
- Being tested
- SHR0302, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0302Drug
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.
PlaceboDrug
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| SHR0302 dose1 | Experimental | Not described Receives: Drug: SHR0302 |
| SHR0302 dose2 | Experimental | Not described Receives: Drug: SHR0302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20 response rate at week 24
Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 24
Measured: Week 24
Secondary outcomes (7)
ACR20 response rate at week 52
Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 52
Measured: Week 52
ACR50 response rate at week 24 and week 52
Response rate of 50% improvement in American College of Rheumatology (ACR50) criteria at week 24 and week 52
Measured: Week 24 and week 52
ACR70 response rate at week 24 and week 52
Response rate of 70% improvement in American College of Rheumatology (ACR70) criteria at week 24 and week 52
Measured: Week 24 and week 52
Change from baseline in HAQ-DI score at week 24 and week 52
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score at week 24 and week 52
Measured: Week 24 and week 52
Change from baseline in SF-36 score at week 24 and week 52
Change from baseline in the medical outcomes study 36-Item Short-Form Health Survey (SF-36) score at week 24 and week 52
Measured: Week 24 and week 52
DAS28-CRP <2.6 proportion at week 24 and week 52
Disease Activity Score for 28-joint counts based on the c-reaction protein (DAS28-CRP) of less than 2.6
Measured: Week 24 and week 52
DAS28-CRP≤3.2 proportion at week 24 and week 52
Disease Activity Score for 28-joint counts based on the c-reaction protein (DAS28-CRP) of equal to and less than 3.2
Measured: Week 24 and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start31 Jul 2020
- Primary completion30 Jan 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333771
- Sponsor's protocol ID
- SHR0302-301
- Status last verified
- Nov 2023
- First submitted
- 2 Apr 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu J, Jiang Y, Zhang S, Liu S, Su J, Lin C, He X, Wu R, Yang L, Liu H, Duan X, Xu S, Luo H, Liu J, Xie Q, Mi C, Chen L, Zhang N, Gong H, Zhu J, Li Y, Wei H, Qian L, Wang J, Shi X, Jin H, Jiang Z, Xie X, Zhan F, Geng X, Zheng Z, Du Z, Dong G, Sun Y, Zeng X. Ivarmacitinib, a selective Janus kinase 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: results from a phase III randomised clinical trial. Ann Rheum Dis. 2025 Feb;84(2):188-200. doi: 10.1136/ard-2024-226385. Epub 2025 Jan 3.
PubMed 39919893
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Moderate to Severe Active Rheumatoid Arthritis Subjects With Inadequate Response to csDMARDs.
- ClinicalTrials.gov ID
- NCT04333771
- Acronym / sponsor ID
- SHR0302-301
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 3 Apr 2020 (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 study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with moderate to severe active rheumatoid arthritis who had inadequate response to conventional synthetic DMARDs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| SHR0302 dose1 | Experimental | Drug: SHR0302 |
| SHR0302 dose2 | Experimental | Drug: SHR0302 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide signed informed consent.
- RA diagnosis consistent with the 2010 ACR/EULAR criteria;
- Moderate to severe RA defined by 6 or more tender joints, 6 or more swollen joints (68- or 66-joint count), and an ESR of 28 mm/h or greater or a CRP level greater than 5mg/L.
- Subjects were required to have an inadequate response to treatment with csDMARDs before baseline.
- If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already.
Key exclusion criteria (4 listed)
- Pregnant women or refuse to receive contraception during the study.
- Lab abnormality within 4 weeks of randomization as follows: WBC count <3.0×10^9/L；neutrophil count<1.5×10^9/L;hemoglobin level<90.0 g/L ; platelet count <100×10^9/L; AST or ALT levels greater than the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
- History of another autoimmune rheumatic disease ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
- Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 3 months of randomization.
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 |
|---|---|---|
| SHR0302The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks. | Drug | SHR0302 dose1, SHR0302 dose2 |
| PlaceboThe placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks. | Drug | Placebo |
Primary outcome
ACR20 response rate at week 24
Time frame: Week 24
Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 24
7 secondary outcomes
ACR20 response rate at week 52
Time frame: Week 52
ACR50 response rate at week 24 and week 52
Time frame: Week 24 and week 52
ACR70 response rate at week 24 and week 52
Time frame: Week 24 and week 52
Change from baseline in HAQ-DI score at week 24 and week 52
Time frame: Week 24 and week 52
Change from baseline in SF-36 score at week 24 and week 52
Time frame: Week 24 and week 52
DAS28-CRP <2.6 proportion at week 24 and week 52
Time frame: Week 24 and week 52
DAS28-CRP≤3.2 proportion at week 24 and week 52
Time frame: Week 24 and week 52
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 22 Nov 2023.
- Derived from this study: PubMed 39919893Liu J, Jiang Y, Zhang S, Liu S, Su J, Lin C, He X, Wu R, Yang L, Liu H, Duan X, Xu S, Luo H, Liu J, Xie Q, Mi C, Chen L, Zhang N, Gong H, Zhu J, Li Y, Wei H, Qian L, Wang J, Shi X, Jin H, Jiang Z, Xie X, Zhan F, Geng X, Zheng Z, Du Z, Dong G, Sun Y, Zeng X. Ivarmacitinib, a selective Janus kinase 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: results from a phase III randomised clinical trial. Ann Rheum Dis. 2025 Feb;84(2):188-200. doi: 10.1136/ard-2024-226385. Epub 2025 Jan 3.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SHR0302 in people with Rheumatoid Arthritis, run by Jiangsu HengRui Medicine Co., Ltd. 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 4 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 22 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. Some participants in this study may receive a placebo. 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?
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?
ACR20 response rate at week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04333771, which also lists 1 linked publication.
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 22 Nov 2023.