Trial | NCT04704492  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    8
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.
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).
Study Started
Aug 14
2012
Primary Completion
Dec 16
2013
Study Completion
Dec 16
2013
Last Update
Jan 11
2021

Drug Biological: SM03

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

  • Other names: SM03

Biological: SM03 Experimental

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

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
No Results Posted