Back to resultsA Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Biological: SM03
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria 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 C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes.
- Receiving methotrexate (MTX) 7.5 - 25mg/week (oral) for at least 12 weeks, at a stable dose over the past 4 weeks.
Exclusion Criteria:
- Females who are pregnant, breastfeeding, or planning a pregnancy during the Treatment Period of and 12 months after the last infusion of study drug.
- Rheumatic autoimmune disease other than RA.
- Use of any biological DMARDs for RA within past 6 months.
- Active infection, or history of serious or chronic infection.
- Any significant cardiac disease, moderate to severe chronic obstructive pulmonary disease.
- Allergy or sensitivity to components of the drug vial or any of the materials used for infusion
Sites / Locations
- Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biological: SM03
Arm Description
Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0 , 2.
Outcomes
Primary Outcome Measures
Area Under the Concentration Time Cure(AUC0-t)
Pharmacokinetic endpoint: Area Under the Concentration Time Cure(AUC0-t)
Time to Maximum Plasma Concentration (Tmax)
Pharmacokinetic endpoint: Time to Maximum Plasma Concentration (Tmax)
Peak Plasma Concentration (Cmax)
Pharmacokinetic endpoint: Peak Plasma Concentration (Cmax)
Systemic Clearance (CL)
Pharmacokinetic endpoint: Systemic Clearance (CL)
Terminal Half-life (T1/2)
Pharmacokinetic endpoint:Terminal Half-life (T1/2)
Secondary Outcome Measures
Number of Participants Who Experienced at Least One Adverse Event
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Number of ACR20, ACR50, and ACR70 Responders at Week 12
American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD
Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 12
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.
Full Information
NCT ID
NCT04704492
First Posted
January 6, 2021
Last Updated
January 8, 2021
Sponsor
SinoMab BioScience Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04704492
Brief Title
A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis
Official Title
An Open-label, Multiple-dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Preliminary Clinical Activity and Safety of Human Mouse Chimeric Anti-CD22 Monoclonal Antibody (SM03) in Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 14, 2012 (Actual)
Primary Completion Date
December 16, 2013 (Actual)
Study Completion Date
December 16, 2013 (Actual)
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
This was an open phase I trial to evaluate the pharmacokinetic, pharmacodynamic, safety and clinical activity profiles of anti-CD22 monoclonal antibody SM03 in patients with active RA.
Detailed Description
This was an open phase I trial to evaluate the PK, PD, safety,tolerability, efficacy, and immunogenicity of SM03 in patients with RA. The total study duration was approximately 16 weeks for each participant, including a screening period of maximally 4 weeks, a multiple-dose period of 2 weeks (day 0 ~ day 14), and a post-treatment follow-up period of 10 weeks (day 15 ~ day 84).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biological: SM03
Arm Type
Experimental
Arm Description
Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0 , 2.
Intervention Type
Drug
Intervention Name(s)
Biological: SM03
Other Intervention Name(s)
SM03
Intervention Description
Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0,2
Primary Outcome Measure Information:
Title
Area Under the Concentration Time Cure(AUC0-t)
Description
Pharmacokinetic endpoint: Area Under the Concentration Time Cure(AUC0-t)
Time Frame
Week 0 to 12
Title
Time to Maximum Plasma Concentration (Tmax)
Description
Pharmacokinetic endpoint: Time to Maximum Plasma Concentration (Tmax)
Time Frame
Week 0,2
Title
Peak Plasma Concentration (Cmax)
Description
Pharmacokinetic endpoint: Peak Plasma Concentration (Cmax)
Time Frame
Week 0, 2
Title
Systemic Clearance (CL)
Description
Pharmacokinetic endpoint: Systemic Clearance (CL)
Time Frame
Week 0 to 12
Title
Terminal Half-life (T1/2)
Description
Pharmacokinetic endpoint:Terminal Half-life (T1/2)
Time Frame
Week 0 to 12
Secondary Outcome Measure Information:
Title
Number of Participants Who Experienced at Least One Adverse Event
Description
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Time Frame
Week 0 to 12
Title
Number of ACR20, ACR50, and ACR70 Responders at Week 12
Description
American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD
Time Frame
Week 2,4,8,12
Title
Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 12
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
Week 0,2,4,8,12
Other Pre-specified Outcome Measures:
Title
Number of Participants Positive for Anti-Drug Antibody (ADA)
Description
Serum ADA positivity is determined over course of the trial duration
Time Frame
Week 0,4,8,12
Title
Change From Baseline in CD19+ B-cell Count During the Study Period
Description
Pharmacodynamic endpoint: change from baseline in CD19+ B-cell count during the study period
Time Frame
Week 0,4,8,12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria 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 C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes.
Receiving methotrexate (MTX) 7.5 - 25mg/week (oral) for at least 12 weeks, at a stable dose over the past 4 weeks.
Exclusion Criteria:
Females who are pregnant, breastfeeding, or planning a pregnancy during the Treatment Period of and 12 months after the last infusion of study drug.
Rheumatic autoimmune disease other than RA.
Use of any biological DMARDs for RA within past 6 months.
Active infection, or history of serious or chronic infection.
Any significant cardiac disease, moderate to severe chronic obstructive pulmonary disease.
Allergy or sensitivity to components of the drug vial or any of the materials used for infusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei Hu, PhD,MD
Organizational Affiliation
Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100032
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis
We'll reach out to this number within 24 hrs