Rheumatoid ArthritisPhase 2NCT03254966

Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients

A Phase 2 study testing SHR0302 in people with Rheumatoid Arthritis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 70 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: 194 participants
Where: 1 siteChina
Study dates: 24 Nov 2017to 12 Oct 2019
Phase: Phase 2
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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,

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Peking Union Medical College Hospital
Beijing, 100032

Other trials in China

About this study

Official title: Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Safety and Efficacy of SHR0302 in Patients With Moderate to Severe Active Rheumatoid Arthritis

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

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
Oral tablets
PlaceboDrug
Oral tablets

Study groups in NCT03254966
Study group	Role	What they receive
SHR0302 dose level 1	Experimental	Not described Receives: Drug: SHR0302
SHR0302 dose level 2	Experimental	Not described Receives: Drug: SHR0302
SHR0302 dose level 3	Experimental	Not described Receives: Drug: SHR0302
SHR0302 dose level 4	Experimental	Not described Receives: Drug: SHR0302
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12
Measured: Baseline - Week 12

Secondary outcomes (9)

Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24
Measured: Baseline - Week 24
Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 12
Measured: Baseline - Week 12
Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 24
Measured: Baseline - Week 24
Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 12
Measured: Baseline - Week 12
Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 24
Measured: Baseline - Week 24
Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 12
Measured: Baseline - Week 12
Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 24
Measured: Baseline - Week 24
Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 12
Measured: Baseline - Week 12
Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 24
Measured: Baseline - Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Nov 201712 Oct 2019

First posted21 Aug 2017
Study start24 Nov 2017
Primary completion16 Apr 2019
Study completion12 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 194 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03254966
Sponsor's protocol ID: SHR0302-201
Status last verified: Sep 2021
First submitted: 15 Aug 2017
Last updated: 30 Sep 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
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RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Safety and Efficacy of SHR0302 in Patients With Moderate to Severe Active Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT03254966
Acronym / sponsor ID: SHR0302-201
Conditions: Rheumatoid Arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 194 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 24 Nov 2017 (actual)
Primary completion: 16 Apr 2019 (actual)
Study completion: 12 Oct 2019 (actual)
First posted: 21 Aug 2017 (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.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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,

Key exclusion criteria (2 listed)

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

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
SHR0302Oral tablets	Drug	SHR0302 dose level 1, SHR0302 dose level 2, SHR0302 dose level 3, SHR0302 dose level 4
PlaceboOral tablets	Drug	Placebo

Primary outcome

Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12
Time frame: Baseline - Week 12

9 secondary outcomes

Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24
Time frame: Baseline - Week 24
Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 12
Time frame: Baseline - Week 12
Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 24
Time frame: Baseline - Week 24
Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 12
Time frame: Baseline - Week 12
Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 24
Time frame: Baseline - Week 24
Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 12
Time frame: Baseline - Week 12
Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 24
Time frame: Baseline - Week 24
Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 12
Time frame: Baseline - Week 12
Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 24
Time frame: Baseline - Week 24

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 30 Sep 2021.
Individual participant dataSharing planned: Undecided

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

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.

Xiaofeng Zeng principal investigator

Peking Union Medical College Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 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 5 inclusion and 2 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 30 Sep 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12 (time frame: Baseline - Week 12). 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 NCT03254966.

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 30 Sep 2021.