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CompletedNCT04333771Updated Nov 22, 2023

A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis

A Phase 3 interventional study of SHR0302 and Placebo in Rheumatoid Arthritis, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
566
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis, Rheumatoid

2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's enrollment of 566 is above the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 570 studies on the registry; 85 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.

Browse Jiangsu HengRui Medicine Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
566 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    SHR0302 dose1

    Drug: SHR0302

  • Experimental
    SHR0302 dose2

    Drug: SHR0302

Interventions

  • DrugSHR0302

    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.

  • DrugPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. ACR20 response rate at week 24

    Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 24

    Time frame: Week 24

Secondary outcomes

  1. ACR20 response rate at week 52

    Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 52

    Time frame: Week 52

  2. 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

    Time frame: Week 24 and week 52

  3. 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

    Time frame: Week 24 and week 52

  4. 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

    Time frame: Week 24 and week 52

  5. 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

    Time frame: Week 24 and week 52

  6. 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

    Time frame: Week 24 and week 52

  7. 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

    Time frame: Week 24 and week 52

07

Study locations

1 site
  • Liuzhou workers' Hospital
    Liuzhou, Guangxi, China
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2020 to primary completion in Jan 2023, 29 months.

Of 117 industry-sponsored phase 3 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 31. This study's 29 months is above that.

Counting every sponsor, half of 148 studies reached it within 26 months; a quarter within 16 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2020
First posted
Apr 3, 2020
StartActual
Jul 31, 2020
Primary completionActual
Jan 30, 2023
CompletionActual
Sep 21, 2023
Last update
Nov 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04333771
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Apr 3, 2020
Start date
Jul 31, 2020
Primary completion
Jan 30, 2023
Completion
Sep 21, 2023
Last update
Nov 22, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ivarmacitinib

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