Back to resultsA Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX
Primary Purpose
Rheumatoid Arthritis(RA)
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SM03
Placebo
MTX
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis(RA)
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.
Sites / Locations
- Peking Union Medical College HostipalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SM03 600 mg
Placebo
Arm Description
SM03: 600 mg intravenous (IV) Randomizd period:on week 0,2,4 and 12,14,16;Participants with inadequate response (defined as less than 10% improvement from baseline in TJC and SJC by Week 12) were rescued with open label SM03 600 mg IV treatment. Open-lable treatment on week 24,30,36,42,48; Methotrexate: 7.5-20 mg/wk oral.
placebo: 600 mg intravenous (IV) on week 0,2, 4, and week 12,14,16;Participants with inadequate response (defined as less than 10% improvement from baseline in TJC and SJC by Week 12) were rescued with open label SM03 600 mg IV treatment. SM03: 600 mg intravenous (IV) on week 24,30,36,42,48; Methotrexate: 7.5-20 mg/wk oral.
Outcomes
Primary Outcome Measures
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24
To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements:
Physician's global assessment of disease activity (assessed using a 10 cm Visual Analog Scale [VAS]); Patient's global assessment of disease activity (assessed using a 10 cm VAS); Patient's assessment of pain (assessed using a 10 cm VAS); Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3); Acute phase reactant: C-reactive protein (CRP)
Secondary Outcome Measures
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12,52
To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements:
Physician's global assessment of disease activity (assessed using a 10 cm Visual Analog Scale [VAS]); Patient's global assessment of disease activity (assessed using a 10 cm VAS); Patient's assessment of pain (assessed using a 10 cm VAS); Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3); Acute phase reactant: C-reactive protein (CRP)
Percentage of Participants With an ACR50/ACR70 Response at Week 12,24,52
To achieve an ACR50/ACR70 required at least a 50%/70% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50%/70% improvement in three of the following five additional measurements:
Physician's global assessment of disease activity (assessed using a 10 cm Visual Analog Scale [VAS]); Patient's global assessment of disease activity (assessed using a 10 cm VAS); Patient's assessment of pain (assessed using a 10 cm VAS); Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3); Acute phase reactant: C-reactive protein (CRP)
Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 12,24,52
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The number of swollen and tender joints assessed using the 28-joint count; Erythrocyte sedimentation rate (ESR); Patient's global assessment of disease activity measured on a 10 cm visual analog scale.
The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 12,24,52
A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.
A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2.
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2.
No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1.
Percentage of Participants With Adverse Events
Percentage of participants who reported an AE or SAE, a drug-related AE, who had an acute infusion reaction, an AE leading to study drug discontinuation, with an infection or serious infection, or who died.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04312815
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 28, 2017 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SinoMab BioScience Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis(RA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
510 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SM03 600 mg
Arm Type
Experimental
Arm Description
SM03: 600 mg intravenous (IV) Randomizd period:on week 0,2,4 and 12,14,16;Participants with inadequate response (defined as less than 10% improvement from baseline in TJC and SJC by Week 12) were rescued with open label SM03 600 mg IV treatment.
Open-lable treatment on week 24,30,36,42,48; Methotrexate: 7.5-20 mg/wk oral.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo: 600 mg intravenous (IV) on week 0,2, 4, and week 12,14,16;Participants with inadequate response (defined as less than 10% improvement from baseline in TJC and SJC by Week 12) were rescued with open label SM03 600 mg IV treatment.
SM03: 600 mg intravenous (IV) on week 24,30,36,42,48; Methotrexate: 7.5-20 mg/wk oral.
Intervention Type
Drug
Intervention Name(s)
SM03
Intervention Description
SM03: 600 mg intravenous (IV)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo: 600 mg intravenous (IV)
Intervention Type
Drug
Intervention Name(s)
MTX
Intervention Description
Methotrexate: 7.5-20 mg/wk oral
Primary Outcome Measure Information:
Title
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24
Description
To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements:
Physician's global assessment of disease activity (assessed using a 10 cm Visual Analog Scale [VAS]); Patient's global assessment of disease activity (assessed using a 10 cm VAS); Patient's assessment of pain (assessed using a 10 cm VAS); Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3); Acute phase reactant: C-reactive protein (CRP)
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12,52
Description
To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements:
Physician's global assessment of disease activity (assessed using a 10 cm Visual Analog Scale [VAS]); Patient's global assessment of disease activity (assessed using a 10 cm VAS); Patient's assessment of pain (assessed using a 10 cm VAS); Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3); Acute phase reactant: C-reactive protein (CRP)
Time Frame
Week 12,52
Title
Percentage of Participants With an ACR50/ACR70 Response at Week 12,24,52
Description
To achieve an ACR50/ACR70 required at least a 50%/70% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50%/70% improvement in three of the following five additional measurements:
Physician's global assessment of disease activity (assessed using a 10 cm Visual Analog Scale [VAS]); Patient's global assessment of disease activity (assessed using a 10 cm VAS); Patient's assessment of pain (assessed using a 10 cm VAS); Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3); Acute phase reactant: C-reactive protein (CRP)
Time Frame
Week 12,24,52
Title
Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 12,24,52
Description
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The number of swollen and tender joints assessed using the 28-joint count; Erythrocyte sedimentation rate (ESR); Patient's global assessment of disease activity measured on a 10 cm visual analog scale.
The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.
Time Frame
Baseline and Week12,24,52
Title
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 12,24,52
Description
A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.
A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2.
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2.
No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1.
Time Frame
Baseline and Week12,24,52
Title
Percentage of Participants With Adverse Events
Description
Percentage of participants who reported an AE or SAE, a drug-related AE, who had an acute infusion reaction, an AE leading to study drug discontinuation, with an infection or serious infection, or who died.
Time Frame
For Placebo arm: Baseline up to week 24; For SM03 arm: Baseline up to week 52;
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Nie, Ms
Phone
(86)755-26611079
Email
niexin@sinomab.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zeng, MD
Organizational Affiliation
Department of Rheumatology and Immunology, Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hostipal
City
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Nie
Phone
(86)755-26611079
Email
niexin@sinomab.com
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zeng, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
35688465
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.
Results Reference
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A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX
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