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Moderate to Severe Active Rheumatoid ArthritisPhase 3NCT06048224

Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of Recombinant Anti-interleukin-6 Receptor Humanized Monoclonal Antibody Injection in Combination With Methotrexate and Jamelor ® in the Treatment of Moderate to Severe Rheumatoid Arthritis

A Phase 3 study testing HS628+MTX and Actemra +MTX in people with Moderate to Severe Active Rheumatoid Arthritis, run by Zhejiang Hisun Pharmaceutical 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

This is a multi-center, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of intravenous HS628 in combination with MTX versus Actemra in combination with MTX, in participants with moderate to severe active rheumatoid arthritis (RA) who have inadequate response to current MTX therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
HS628+MTX and Actemra +MTX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
669 participants
Where
1 siteChina
Study dates
28 Dec 2020to 31 Jan 2022
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

  • the person who has signed the informed consent and can complete the test according to the program;
  • age ≥18 years old and ≤75 years old (subject to the date of signing the informed consent), male or female;
  • weight ≥30kg;
  • according to the 2010 ACR/EULAR diagnostic criteria, rheumatoid arthritis was diagnosed with the disease duration ≥ 6 months;
  • swelling and tenderness joint count ≥ 6 (based on 66 joint counts) and tenderness joint count ≥ 6 (based on 68 joint counts) during the screening period, if both swelling and tenderness are present in the same joint, the joint shall be included in both swelling and tenderness joint count (excluding artificial joints);
  • C-reactive protein (CRP) ≥10mg/L or erythrocyte sedimentation rate (ESR) > 28mm/hr at the screening stage;
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  • patinents who had received DMARD treatment for at least 3 months before screening visit;
  • Inadequate response to previous or current methotrexate treatment;
  • patients who received at least 12 weeks of oral methotrexate treatment (≥ 7.5mg/week) and at least 4 weeks of stable oral dose (methotrexate dose 7.5-25mg/week, with critical value) before random administration;
  • all non-biological agents DMARD except methotrexate should be discontinued for at least 2 weeks before random administration( In addition, leflunomide should be discontinued for ≥8 weeks, and at least 2 weeks before randomized administration if standard coletenide therapy or activated carbon elution has been followed; Discontinuation of sulfasalazine ≥4 weeks; Yunke withdrawal ≥12 weeks）;
  • Patinents who will receive oral folic acid treatment (at least 5 mg/ week or a dose determined according to local medical practice) or an equivalent drug (a combination of drugs required for MTX treatment) throughout the study, and the dose of folic acid or an equivalent drug was stable for at least 2 weeks prior to random administration.
  • biologic DMARD should have been discontinued for at least 2 weeks prior to random administration.For example, adamumab, setuzumab, infliximab and golimumab should be discontinued for ≥8 weeks.Etanercept (enley, esipher, and jeanke), Anbainuo should be discontinued for ≥ 4 weeks;Tofetib and baritinib should be discontinued for ≥2 weeks;
  • any Chinese herbal medicine, proprietary Chinese medicine or natural medicine for the treatment of RA has been discontinued for at least 2 weeks before random administration;
  • any non-steroidal anti-inflammatory drug must be given at a stable dose for at least 2 weeks prior to random administration;
  • at the time of screening, if the subject was taking prednisone or a comparable dose of glucocorticoid, the prerandomized stable dose (prednisone dose ≤10mg/ day) was administered for at least 4 weeks;
  • Non-lactating women and non-pregnant women (negative blood pregnancy test for women of childbearing age; the subject or his or her spouse will use appropriate and effective contraceptive methods, such as abstinence, oral contraceptives, Iuds, or double barrier methods, during the trial period and for 3 months after the end of the last dose.

Who cannot join

  • Subjects have previously received Tocilizumab treatment or are allergic to any component of Tocilizumab (or investigational drug product);
  • Subjects with long-term bedridden/wheelchair;
  • Subjects with inflammatory joint disease other than rheumatoid arthritis in their previous or current medical history; or other systemic autoimmune diseases;
  • Current symptoms of severe, progressive or uncontrolled diseases of renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral. Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study;
  • Subjects with history of severe hypersensitivity or anaphylaxis to human, humanized or mouse monoclonal antibodies.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: A Randomized Controlled, Double-blind, Phase III, Multicenter Clinical Study of HS628 Versus Actemra® in Combination With Methotrexate as Therapy in Patients With Moderate to Severe Rheumatoid Arthritis

This is a multi-center, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of intravenous HS628 in combination with MTX versus Actemra in combination with MTX, in participants with moderate to severe active rheumatoid arthritis (RA) who have inadequate response to current MTX therapy. The study comprises a 24-week treatment phase, followed by a 4-week safety observation period.

Being tested
HS628+MTX, Actemra +MTX

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS628+MTXDrug

    Participants will receive HS628 SC injections Q4W along with MTX orally for 24-week

  • Actemra +MTXDrug

    Participants will receive tocilizumab SC injections Q4W along with MTX orally for 24-week

Study groups in NCT06048224
Study groupRoleWhat they receive
HS628ExperimentalSubjects will receive 8mg/kg intravenous(IV) HS628 at Week 0,Week 4, Week 8, Week 12, Week 16, Week 20,Week 24
Receives: Drug: HS628+MTX
ActemraActive comparatorSubjects will receive 8mg/kg intravenous(IV) ACTEMRA® at Week 0,Week 4, Week 8, Week 12, Week 16, Week 20,Week 24
Receives: Drug: Actemra +MTX

What is being measured

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

  1. Proportion of patients with an ACR20 response

    The ACR 20 responses: greater than or equal to 20 percent improvement in TJC and SJC (28 assessed joints), and 20% improvement in 3 of the following 5 criteria, respectively: 1) PtAAP- VAS, 2) PtGADA-VAS, 3) PhGADA-VAS, 4) HAQ-DI, and 5) CRP or ESR

    Measured: Week 24

Secondary outcomes (12)

  1. Proportion of patients with an ACR50, 70 response

    The ACR50, 70 responses: greater than or equal to 50, 70 percent improvement in TJC and SJC (28 assessed joints), and 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PtAAP- VAS, 2) PtGADA-VAS, 3) PhGADA-VAS, 4) HAQ-DI, and 5) CRP or ESR

    Measured: Week 24

  2. Proportion of patients with an ACR20, 50, 70 response

    The ACR20, 50, 70 responses: greater than or equal to 20, 50 70 percent improvement in TJC and SJC (28 assessed joints), and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PtAAP- VAS, 2) PtGADA-VAS, 3) PhGADA-VAS, 4) HAQ-DI, and 5) CRP or ESR

    Measured: Week 12

  3. Proportion of patients with DAS28 (ESP、CRP) ≤3.2 and <2.6

    The DAS28-ESR（CRP）score is a measure of the patient's disease activity calculated using the tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), patient's global assessment (PGA) of disease activity based on visual analog scale (VAS) and the erythrocyte sedimentation rate (C-reactive protein) in millimeter/hour (mm/hr)（mg/L）. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total possible score ranged from 0 to 10. Higher scores represent higher disease activity. A negative change from baseline indicates an improvement

    Measured: Week 12

  4. Proportion of patients with DAS28 (ESP、CRP) ≤3.2 and <2.6

    The DAS28-ESR（CRP）score is a measure of the patient's disease activity calculated using the tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), patient's global assessment (PGA) of disease activity based on visual analog scale (VAS) and the erythrocyte sedimentation rate (C-reactive protein) in millimeter/hour (mm/hr)（mg/L）. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total possible score ranged from 0 to 10. Higher scores represent higher disease activity. A negative change from baseline indicates an improvement

    Measured: Week 24

  5. Simplified Disease Activity Index (SDAI)Change From Baseline

    SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and CRP in mg/dL. Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.

    Measured: Week 12、 Week 24

  6. Clinical Disease Activity Index (CDAI)（Change From Baseline）

    The CDAI is a numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient's global assessment of disease activity (PtGDA) and physician global assessment of disease activity (PGDA) assessed on 0-10 centimeters (cm) visual analogue scale (VAS). Higher scores represent greater affectation due to disease activity.

    Measured: Week 12、 Week 24

  7. Change From Baseline in TJC and SJC

    The number of tender joints (based on 68 joints) and swollen joints (based on 66 joints) were counted at each visit. TJC was determined by identifying the joints that were painful under pressure or to passive motion, A negative change from baseline indicates an improvement.

    Measured: Week 24

  8. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)

    HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week.

    Measured: Week 24

  9. Change From Baseline in the Short Form 36 (SF-36) Health Survey

    The SF-36 Health Survey uses participant-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). A clinically relevant improvement in the Physical and Mental Component Scores of the SF-36 was defined as a ≥ 5-point increase from Baseline.

    Measured: Week 24

  10. Change From Baseline in CRP

    as stated above

    Measured: Week 12、Week 24

  11. Change From Baseline in ESR

    as stated above

    Measured: Week 12、Week 24

  12. Change From Baseline in VAS（PtAAP-VAS、PtGADA-VAS、PhGADA-VAS）

    as stated above

    Measured: Week 12、Week 24

Timeline

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

  1. First posted21 Sep 2023
  2. Study start28 Dec 2020
  3. Primary completion14 Sep 2021
  4. Study completion31 Jan 2022

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
669 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06048224
Sponsor's protocol ID
HS628-III
Status last verified
Sep 2023
First submitted
6 Sep 2023
Last updated
21 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HS628+MTX and Actemra +MTX in people with Moderate to Severe Active Rheumatoid Arthritis, run by Zhejiang Hisun Pharmaceutical 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 16 inclusion and 5 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 21 Sep 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. 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?

Proportion of patients with an ACR20 response (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 NCT06048224.

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 21 Sep 2023.

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