NCT04333771

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
566

participants targeted

Target at P75+ for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Jul 2020

Typical duration for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 31, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

2.5 years

First QC Date

April 2, 2020

Last Update Submit

November 21, 2023

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • ACR20 response rate at week 24

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

    Week 24

Secondary Outcomes (7)

  • ACR20 response rate at week 52

    Week 52

  • ACR50 response rate at week 24 and week 52

    Week 24 and week 52

  • ACR70 response rate at week 24 and week 52

    Week 24 and week 52

  • Change from baseline in HAQ-DI score at week 24 and week 52

    Week 24 and week 52

  • Change from baseline in SF-36 score at week 24 and week 52

    Week 24 and week 52

  • +2 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

SHR0302 dose1

EXPERIMENTAL
Drug: SHR0302

SHR0302 dose2

EXPERIMENTAL
Drug: SHR0302

Interventions

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.

SHR0302 dose1SHR0302 dose2
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.

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liuzhou workers' Hospital

Liuchow, Guangxi, China

Location

Related Publications (1)

  • 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.

    PMID: 39919893DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ivarmacitinib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2020

First Posted

April 3, 2020

Study Start

July 31, 2020

Primary Completion

January 30, 2023

Study Completion

September 21, 2023

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

CN(1)