NCT03254966

Brief Summary

To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to severe active rheumatoid arthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P50-P75 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Nov 2017

Typical duration for phase_2 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

August 15, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 24, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2019

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

August 15, 2017

Last Update Submit

September 24, 2021

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12

    Baseline - Week 12

Secondary Outcomes (9)

  • Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24

    Baseline - Week 24

  • Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 12

    Baseline - Week 12

  • Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 24

    Baseline - Week 24

  • Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 12

    Baseline - Week 12

  • Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 24

    Baseline - Week 24

  • +4 more secondary outcomes

Study Arms (5)

SHR0302 dose level 1

EXPERIMENTAL
Drug: SHR0302

SHR0302 dose level 2

EXPERIMENTAL
Drug: SHR0302

SHR0302 dose level 3

EXPERIMENTAL
Drug: SHR0302

SHR0302 dose level 4

EXPERIMENTAL
Drug: SHR0302

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SHR0302DRUG

Oral tablets

SHR0302 dose level 1SHR0302 dose level 2SHR0302 dose level 3SHR0302 dose level 4
PlaceboDRUG

Oral tablets

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female subjects who are 18 - 70 (inclusive) years of age on the day of signing informed consent
  • have a diagnosis of RA meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III
  • have ≥6 swollen joints (from a 66-joint count) and ≥8 tender joints (from a 68-joint count) at Screening and at Baseline, Screening serum c-reactive protein (CRP)or hsCRP \> 1.2 x upper limit of laboratory normal range (ULN),or erythrocyte sedimentation rate (ESR) \> 28 mm/h
  • have not used any disease modifying anti-rheumatic drug (DMARD) or have an inadequate response to one or more kinds of conditional DMARDs (methotrexate, leflunomide, Chloroquine, hydroxychloroquine, sulfasalazine, minocycline, penicillamine, auranofin or injection gold preparation, and iguratimod) due to lack of efficacy or toxicity, and have agreed to be washed out from these conditional DMARDs for a period of at least 7 t1/2s prior to randomization, with the exception of antimalarials, which must be at a stable dose for at least 12 weeks prior to randomization
  • Body mass index (BMI = weight/height squared (kg/m2)) within the range of 18 to 35,

You may not qualify if:

  • current or previous RA treatment with a jak inhibitor
  • current or previous RA treatment with a biologic DMARD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100032, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ivarmacitinib

Condition Hierarchy (Ancestors)

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

Study Officials

  • Xiaofeng Zeng

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 21, 2017

Study Start

November 24, 2017

Primary Completion

April 16, 2019

Study Completion

October 12, 2019

Last Updated

September 30, 2021

Record last verified: 2021-09

Locations

CN(1)