A Phase 3 interventional study of HS628+MTX and Actemra +MTX in Moderate to Severe Active Rheumatoid Arthritis, sponsored by Zhejiang Hisun Pharmaceutical Co. Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Zhejiang Hisun Pharmaceutical Co. Ltd. · Phase 3, Interventional, and Treatment
Among 113 studies testing methotrexate in Arthritis, Rheumatoid — 8 open to participants now, 10 under way, 2 of them phase 3. Methotrexate · Arthritis, Rheumatoid.
Among the 113 studies testing methotrexate in Arthritis, Rheumatoid, this one is the 9th largest by enrollment, is the only one that started in 2020, is one of 47 in phase 3, and was the 108th registered.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 669 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →8 of the 113 studies testing methotrexate in Arthritis, Rheumatoid are open now, in 5 countries. Each count lists the studies.
Methotrexate: first FDA approval 1953 (METHOTREXATE SODIUM), first EMA approval 2016. What it is approved for, and how studies give it, is on its page →
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →113 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked.
Median enrollment 130 across the 113 interventional studies. Of the 93 that completed or were terminated, 58 (62%) have results posted.
84 of 113 have an industry lead sponsor. The 10 most frequent:
Zhejiang Hisun Pharmaceutical Co. Ltd. is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Zhejiang Hisun Pharmaceutical Co. Ltd. has 3 studies filed under Arthritis, Rheumatoid — fewer than ten, so there is no comparison to draw.
3 of the studies testing methotrexate in Arthritis, Rheumatoid that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05353829Region VästerbottenMethotrexate in Patients with Early Rheumatoid Arthritis | 2026-12-31 |
| NCT06590090XBiotech, Inc.Natrunix in Combination With Methotrexate for Rheumatoid Arthritis Treatment | 2027-01-15 |
| NCT06649136Medical University of ViennaMethMax Trial: MAXimising the METHotrexate Therapy Potential in Patients With Active Rheumatoid Arthritis | 2027-06-07 |
Among the 113 studies testing methotrexate in Arthritis, Rheumatoid, from their registry updates:
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.
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.
the person who has signed the and can complete the test according to the program;
Subjects have previously received Tocilizumab treatment or are allergic to any component of Tocilizumab (or drug product);
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive 8mg/kg intravenous(IV) HS628 at Week 0,Week 4, Week 8, Week 12, Week 16, Week 20,Week 24
Drug: HS628+MTX
Subjects will receive 8mg/kg intravenous(IV) ACTEMRA® at Week 0,Week 4, Week 8, Week 12, Week 16, Week 20,Week 24
Drug: Actemra +MTX
Drug page: Methotrexate
Participants will receive HS628 SC injections Q4W along with MTX orally for 24-week
Drug pages: Tocilizumab · Methotrexate
Participants will receive tocilizumab SC injections Q4W along with MTX orally for 24-week
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
Time frame: Week 24
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
Time frame: Week 24
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
Time frame: Week 12
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
Time frame: Week 12
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
Time frame: Week 24
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.
Time frame: Week 12、 Week 24
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.
Time frame: Week 12、 Week 24
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.
Time frame: Week 24
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.
Time frame: Week 24
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.
Time frame: Week 24
Change From Baseline in CRP
as stated above
Time frame: Week 12、Week 24
Change From Baseline in ESR
as stated above
Time frame: Week 12、Week 24
Change From Baseline in VAS（PtAAP-VAS、PtGADA-VAS、PhGADA-VAS）
as stated above
Time frame: Week 12、Week 24
Ran from Dec 2020 to primary completion in Sep 2021, 8 months.
Of 116 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 8 months is below that.
Counting every sponsor, half of 148 studies reached it within 26 months; a quarter within 17 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methotrexate
Zhejiang Hisun Pharmaceutical Co. Ltd.