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

• Status: Completed
• Trial end date: 2013-12-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SinoMab Pty Ltd

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