Moderate and Severe RheumatoId Arthritis
Conditions
Brief summary
The purpose of this study is to initially access the safety and effectivity of RC18 combined with methotrexate (MTX) in comparison with the use of methotrexate alone in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response to MTX therapy.
Interventions
BIOLOGICALPlacebo plus MTX
The trial was divided into two groups: (1) placebo + MTX; (2) telitacicept 160 mg + MTX. MTX was used as the basic treatment, the dose of MTX was stable during the trial, and could not be adjusted. Telitacicept or placebo was administered once a week for the first 24 weeks. Beginning at week 24, subjects in the placebo group will enter the RC-18 treatment group. All subjects received RC-18 treatment once a week from week 24 to week 48.
BIOLOGICALRC18 160 mg plus MTX
The trial was divided into two groups: (1) placebo + MTX; (2) telitacicept 160 mg + MTX. MTX was used as the basic treatment, the dose of MTX was stable during the trial, and could not be adjusted. Telitacicept or placebo was administered once a week for the first 24 weeks. Beginning at week 24, subjects in the placebo group will enter the RC-18 treatment group. All subjects received RC-18 treatment once a week from week 24 to week 48.
Sponsors
RemeGen Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of adult onset RA by a physician as defined by the 1987 and/or 2010 ACR criteria and ESR or C - reaction protein ( CRP ) is greater than the normal range; * Aged 18-65 years old; * Consent to use effective contraception during the study period (women of childbearing age); * Patients with an inadequate response to existing therapies at least one anti-TNFs Infliximab (Remicade ) at least three times, adalimumab (Humira), at least four times, etanercept ( Enbrel) use at least 8 weeks, etanercept use at least 8 weeks.And Last medication time to randomization more than 12 weeks; * Voluntarily signed informed consent; * Patients have been taking MTX for at least 12 weeks at the screening and maintaining dose stability ≥7.5mg/ weeks (or equivalent dose) 4 weeks before randomization; * Treatment with traditional oral disease-modifying antirheumatic drugs (DMARD) /immunosuppressive agents other than MTX within 4 weeks or 12 weeks before the screening visit, depending on DMARD; * If subjects are receiving treatment of corticosteroid, must stabilize dose (dose of prednisone) at least equal to or less than 10mg/day for 4 weeks (before randomization); * If subjects are receiving treatment of NSAIDs,must stabilize dose (dose of prednisone) at least 4 weeks (before randomization); * When the patient's condition to achieve moderate to severe active RA at the screening, defined as at least 6/68 tenderness joints and at least 6/66 swollen joints.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients in each group reached ACR20 at week 24 | Week 24（Visit 9） | ACR20 response: Patients with tenderness and swollen joint counts and 20% improvement,At least 3 20% improvement in the following 5:a.Health Assessment Questionnaire;b.Subjects assessed pain VAS score;c.Assess the overall situation of the disease subject VAS score;d.Researchers assessed the overall situation of the disease in the VAS score;e.Acute phase reactants(ESR or CRP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Low Disease Activity and clinical remission. (DAS28 ≤3.20 and DAS28 < 2.6). | Week 24 | Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score \>5.10=higher disease activity; \<3.20=low disease activity; \<2.60=clinical remission. |
| Percentage of Participants Achieving American College of Rheumatology ACR50 and ACR70 Responses at week 12 or week 24. | Week 12 and Week 24 | — |
| Percentage of Participants Achieving American College of Rheumatology ACR50 and ACR70 Responses at week 24. | Week 24 | — |
| Percentage of Participants With American College of Rheumatology 20% ,50% and 70% (ACR20, ACR50 and ACR70) Response | Week 4, Week 8, Week 12, Week 28, Week 32, Week 40, Week48 | — |
| Change From Baseline in Joint Space Narrowing and Erosions at week 24 and week 48. | Week 24,Week48 | Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion).And Joint space narrowing score (a component of the modified TSS) also is a measure of change in joint health. Joint space narrowing score range is 0 (no narrowing) to 168 (high narrowing). |
| Sharp Score Relative Change from Baseline at Week 24 | Week 24 | — |
Countries
China
Outcome results
None listed