A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis

NCT ID: NCT04704492

Last Updated: 2021-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-14
• Study Completion Date: 2013-12-16

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).

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biological: SM03

Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0 , 2.

Group Type: EXPERIMENTAL

Biological: SM03

Intervention Type: DRUG

Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0,2

Interventions

Biological: SM03

Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0,2

Intervention Type: DRUG

Other Intervention Names

SM03

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SinoMab BioScience Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pei Hu, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital

Locations

Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital

Beijing, , China

Countries

China

Other Identifiers

CTR20131127

Identifier Type: OTHER

Identifier Source: secondary_id

SM03-RA(I/II)-1.0

Identifier Type: -

Identifier Source: org_study_id