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

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).

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