Clinical trial NCT04312815: A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX
Official title: A Randomized,Placebo Controlled, Double-blind, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of SM03, Compared to Placebo, in Patients With Moderate-to-Severely Active Rheumatoid Arthritis Receiving Methotrexate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rheumatoid Arthritis(RA)
Lead sponsor: SinoMab BioScience Ltd
Sponsor class: INDUSTRY
First posted: 2020-03-18
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * To demonstrate that SM03 added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Chinese RA participants with an inadequate response to MTX.
* To assess the safety of SM03 added to MTX in Chinese RA participants with an inadequate response to MTX

Detailed description: The total duration of study was expected up to 58 weeks (screening period of 6 weeks, randomized treatment period of 24 weeks and open-label treatment extention period of 24 weeks , and a 4-week post treatment observation).

Eligibility criteria: Inclusion Criteria:

* Adult patients 18-75 years of age.
* Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria, or 2010 ACR/EULAR for the classification of rheumatoid arthritis.
* Moderate to severe active RA with swollen joint count (SJC) ≥ 6(66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
* At screening, either High sensitivity C-Reactive Protein (hs-CRP) ≥ 1.5 UNL, or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes.
* Inadequate response to methotrexate, having received and tolerated at a dose of 7.5-20 mg/week for ≥ 12 weeks, at a stable dose over the past 4 weeks.

Exclusion Criteria:

* Rheumatic autoimmune disease other than RA.
* Use of any biological DMARDs for RA.
* Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
* Active infection, or history of serious or chronic infection

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12,52
timeFrame: Week 12,52
measure: Percentage of Participants With an ACR50/ACR70 Response at Week 12,24,52
timeFrame: Week 12,24,52
measure: Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 12,24,52
timeFrame: Baseline and Week12,24,52
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 12,24,52
timeFrame: Baseline and Week12,24,52
measure: Percentage of Participants With Adverse Events
timeFrame: For Placebo arm: Baseline up to week 24; For SM03 arm: Baseline up to week 52;
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hostipal
Study officials:
affiliation: Department of Rheumatology and Immunology, Peking Union Medical College Hospital
name: Xiaofeng Zeng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong KL, Li Z, Ma F, Wang D, Song N, Chong CH, Luk KK, Leung SO. SM03, an Anti-CD22 Antibody, Converts Cis-to-Trans Ligand Binding of CD22 against alpha2,6-Linked Sialic Acid Glycans and Immunomodulates Systemic Autoimmune Diseases. J Immunol. 2022 Jun 15;208(12):2726-2737. doi: 10.4049/jimmunol.2100820. Epub 2022 Jun 10.